https://skin.dermsquared.com/skin/issue/feedSKIN The Journal of Cutaneous Medicine2025-01-13T01:57:46+00:00SKIN The Journal of Cutaneous Medicineeditor@jofskin.orgOpen Journal Systems<p><strong>SKIN</strong> is a peer-reviewed, open access, online only journal dedicated to providing free access globally to disseminate dermatological knowledge. Authors retain copyright in their articles, licensing publication of their content through use of Creative Commons CCBY license. The journal does not charge fees, and is supported by the National Society for Cutaneous Medicine. </p>https://skin.dermsquared.com/skin/article/view/3154Early and Sustained Treatment Satisfaction Observed in Patients With Moderate to Severe Psoriasis Treated With Ixekizumab: Results From Second Interim Analysis of the Real-World Psoriasis in Special Areas (PSoSA) Study2024-11-19T16:17:49+00:00April Armstrongjofskin@gmail.comSarah Lonowskijofskin@gmail.comDavid Fivensonjofskin@gmail.comWilliam Malatestinicjofskin@gmail.comMwangi James Muragejofskin@gmail.comMeghan Feely McDonaldjofskin@gmail.comAli Sheikhi Mehrabadijofskin@gmail.comJoseph F. Merolajofskin@gmail.com<p><strong><span data-contrast="auto">Introduction:</span></strong><span data-contrast="auto"> Psoriasis (PsO) is an inflammatory disease that affects 3.2% of the US adult population (1). Patients treated with biological agents show higher treatment satisfaction over those treated with oral therapy, phototherapy and topical therapy (1). Ixekizumab has proven to be effective in treating moderate-to-severe plaque PsO in clinical trials. This analysis describes treatment satisfaction with ixekizumab in a real-world population using the IDEOM-7 (International Dermatology Outcomes Measures) treatment satisfaction questionnaire (2). </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><strong><span data-contrast="auto">Methods: </span></strong><span data-contrast="auto">The Psoriasis in Special Areas (PSoSA) study is a US-based, 52-week (W), prospective, multicenter, single-arm, observational study that enrolled adults with moderate-to-severe plaque PsO and nail involvement, with/without scalp involvement, in patients who initiated ixekizumab. Here, we describe observed data from the second interim analysis of the PSoSA study. Treatment satisfaction is measured using DermStat-7 also referred as IDEOM-7, a 7-item questionnaire completed by patients to assess overall treatment satisfaction using a 5-point response option from 1 “not satisfied”, 2 “slightly satisfied”, 3 “somewhat satisfied”, 4 “mostly satisfied” to 5 “completely satisfied”. This questionnaire is a novel method for assessing effectiveness of treatment (3 items), convenience of treatment (3 items), and a single item assessing overall satisfaction. Patients were requested to complete the IDEOM-7 at each follow-up visit. Here we describe results from the 2</span><span data-contrast="auto">nd</span><span data-contrast="auto"> interim analysis for patients with available data at W4, W12, and W24 based on responses to the questions.</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><strong><span data-contrast="auto">Results</span></strong><span data-contrast="auto">: At W4, 146 patients were analysed. 80.9% (n=106) of the patients treated with ixekizumab responded as “mostly or completely satisfied”, 11.5% (n=15) as “somewhat satisfied”, 6.1% (n=8) as “slightly satisfied” and 1.5% (n=2) as “not satisfied”.</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><span data-ccp-props="{"335551550":6,"335551620":6}"> </span><span data-contrast="auto">At W12, 115 patients were analysed. 85.3% (n=93) of the patients treated with ixekizumab responded as “mostly or completely satisfied”, 7.3% (n=8) as “somewhat satisfied”, 3.7% (n=4) as “slightly satisfied” and 3.7% (n=4) as “not satisfied”.</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><span data-contrast="auto">At W24, 71 patients were analysed. 86.4% (n=57) of the patients treated with ixekizumab responded as “mostly or completely satisfied”, 9.1% (n=6) as “somewhat satisfied”, 1.5% (n=1) as “slightly satisfied” and 3% (n=2) as “not satisfied”.</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><strong><span data-contrast="auto">Conclusion</span></strong><span data-contrast="auto">: In this second interim analysis of the PSoSA study, moderate to severe PsO patients initiating ixekizumab reported high levels of overall treatment satisfaction as early as week 4 which was sustained at week 24. </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <ol> <li data-leveltext="(%1)" data-font="Arial" data-listid="4" data-list-defn-props="{"335552541":0,"335559685":720,"335559991":360,"469769242":[65533,0],"469777803":"left","469777804":"(%1)","469777815":"hybridMultilevel"}" aria-setsize="-1" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Florek AG, Wang CJ, Armstrong AW. Treatment preferences and treatment satisfaction among psoriasis patients: a systematic review. Archives of Dermatological Research. 2018 May;310:271-319.</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></li> </ol> <ol> <li data-leveltext="(%1)" data-font="Arial" data-listid="4" data-list-defn-props="{"335552541":0,"335559685":720,"335559991":360,"469769242":[65533,0],"469777803":"left","469777804":"(%1)","469777815":"hybridMultilevel"}" aria-setsize="-1" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Ball GD, Yee D, Zhang AJ, Perez-Chada LM, Strand V, Merola JF, Armstrong AW, Gottlieb AB. Report of the IDEOM meeting adjacent to the GRAPPA 2023 annual meeting. The Journal of Rheumatology. 2024 Jul 15.</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></li> </ol>2025-01-13T00:00:00+00:00Copyright (c) 2025 April Armstrong, Sarah Lonowski, David Fivenson, William Malatestinic, Mwangi James Murage, Meghan Feely McDonald, Ali Sheikhi Mehrabadi, Joseph F. Merolahttps://skin.dermsquared.com/skin/article/view/2906Elastic Garment Bands in an Adult 2025-01-03T20:10:49+00:00Sara Attarisattari@augusta.eduMargaret Newsomemanewsome@augusta.eduMatthew Belchermbelcher@augusta.edu2025-01-13T00:00:00+00:00Copyright (c) 2025 Sara Attari, Margaret Newsome, Matthew Belcherhttps://skin.dermsquared.com/skin/article/view/2774Leukemia Cutis in An Adult Patient with Acute Lymphoblastic Leukemia: A Review of Histopathology and Immunohistochemistry in Diagnosis2024-10-30T16:51:31+00:00Alessandro Alfieriandro.alfieri@mail.ugm.ac.idSatiti Retno Pudjiatisatiti_rp@ugm.ac.idEry Kus Dwianingsihery_malueka@ugm.ac.id<p>Leukemia Cutis (LC) is a condition of cutaneous infiltration by neoplastic leukocytes. It can manifest in any leukemia, but LC caused by acute lymphoblastic leukemia (ALL) has the rarest incidence compared to other types of leukemia. The examination of histopathological morphology supported by immunohistochemical examination and its correlation with peripheral blood morphology and bone marrow is important in the final diagnosis of LC. We present a LC case of a 35-year-old male patient with ALL, using histopathological and immunohistochemistry examinations to diagnose. This case report aims to help clinicians establish the diagnosis for cutaneous manifestations in patients with ALL by using histopathological and immunohistochemical examinations.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Alessandro Alfieri, Satiti Retno Pudjiati, Ery Kus Dwianingsihhttps://skin.dermsquared.com/skin/article/view/2942Treatment of Generalized Pustular Psoriasis with Bimekizumab2025-01-03T08:21:31+00:00Mimi Chungmimi.chung145@gmail.comBoni E Elewskibelewski@uabmc.edu<p>Generalized pustular psoriasis (GPP) is a rare but serious subtype of pustular psoriasis. In the United States, the IL-36 inhibitor spesolimab is the only medication currently approved for GPP. We describe the longitudinal treatment of a patient with concomitant GPP, plaque psoriasis, and psoriatic arthritis. After almost a decade of recalcitrant disease and difficulty managing cardiovascular concerns, the patient was successfully treated with bimekizumab, a novel biologic targeting IL-17A/F. To our knowledge, this represents the first case of concomitant GPP and plaque psoriasis treated with this immunomodulator, offering additional treatment options for patients with this challenging disease.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Mimi Chung, Boni E Elewskihttps://skin.dermsquared.com/skin/article/view/2832Acute Generalized Exanthematous Pustulosis after Oral Antihistamine2024-10-31T04:13:27+00:00Hannah Rivahriva@ttuhsc.eduMartin Giandonimbgiandoni@aol.comFrank Celisfcnp123@gmail.comCynthia Reyes Barroncreyesba711@gmail.com<p style="font-weight: 400;">Acute generalized exanthematous pustulosis (AGEP) is a cutaneous adverse reaction that may be severe. It is often caused by drug exposure, most commonly antibiotics; however, many others have been implicated. We present a case of hydroxyzine associated AGEP in a 34-year-old man taking the antihistamine for anxiety. The patient presented with a pruritic, erythematous rash on the extremities, trunk and neck. He was initially diagnosed with folliculitis, although Gram stain and culture were negative. With worsening rash, a punch biopsy was performed and showed subcorneal pustules filled with neutrophils, consistent with AGEP. Additional history led to the identification of the causative agent. Hydroxyzine was discontinued, and the patient’s symptoms improved. Although AGEP is usually self-limited, persisting for one to two weeks followed by desquamation, 17 percent of patients will have organ dysfunction and may require hospitalization. Clinicians should be prepared to recognize this potentially severe reaction, particularly when prescribing a new medication, including a common antihistamine, as in this rare case.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Hannah Riva, Martin Giandoni, Frank Celis, Cynthia Reyes Barronhttps://skin.dermsquared.com/skin/article/view/2994Eruptive Melanocytic Nevi Secondary to Chemotherapy in a Pediatric Patient a Case Report2024-10-02T18:39:45+00:00Chloe Haverkampchaverkamp@auburn.vcom.eduRafael Mojia-Ruizrafikines@dermatology.med.ufl.eduMichael Laverym.lavery@dermatology.med.ufl.edu<p style="font-weight: 400;"><strong>Introduction:</strong> Eruptive Melanocytic Nevi (EMN) is an uncommon skin manifestation of either skin trauma, immunosuppression due to internal disease, or pharmacotherapy. As the use of biological therapy increases and new chemotherapy regimens form, there is potential for an increase in the incidence of EMN.</p> <p style="font-weight: 400;"><strong>Case Report:</strong> In the case described in this study, a 9-year-old boy presents with EMN, which formed during his chemotherapy treatment for acute lymphoblastic leukemia (ALL). He completed treatment with a relatively new chemotherapy regimen, which was associated with EMN in one prior study. Since the completion of treatment in 2020, the nevi have remained stable and have not developed any gross or dermoscopic features concerning for malignancy.</p> <p style="font-weight: 400;"><strong>Discussion:</strong> There has not been enough wide-scale research conducted on EMN secondary to chemotherapy to confidently say if these nevi are at a higher risk of malignancy than typical melanocytic nevi. For this reason, current recommendations are to monitor patients with EMN for malignancy closely throughout their lifetime. This case means to increase awareness and understanding of this rare chemotherapy reaction, and potentially contribute to future decision making regarding the management of EMN.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Chloe Haverkamp, Rafael Mojia-Ruiz, Michael Laveryhttps://skin.dermsquared.com/skin/article/view/2673Vulvar Porocarcinoma with Inguinal Nodal Recurrence: A Case Report2024-08-14T16:27:46+00:00Hannah J Porterhannah.porter@uvmhealth.orgNadeem Marghoobnadeem.marghoob@uvmhealth.orgHayden Christensenhayden.christensen@med.uvm.eduMatthew Dinehartmatthewmdinehart@arkansasdermatology.comConor O'Neillconor.oneill@uvmhealth.orgMark Wickmwick@prwlaboratories.comLaura Greenelaura.greene@uvmhealth.orgChristine H Weinbergerchristine.weinberger@uvmhealth.org<p><strong>Introduction: </strong>Porocarcinoma (PC) is an uncommon, aggressive malignancy of the sweat gland apparatus characterized by diverse clinical presentation and challenging histopathology. Patients diagnosed with PC face a grim prognosis due to high rates of recurrence and metastasis.</p> <p><strong>Case Report: </strong>We present a case of a vulvar porocarcinoma initially managed by surgical excisions, achieving clear margins. Subsequent surveillance revealed regional lymph node metastasis, prompting lymph node dissection.</p> <p><strong>Discussion:</strong> Here, we highlight the difficulty in recognizing and managing PC. While surgical excision remains the mainstay of treatment, there exists no consensus on adjuvant therapies and the role of sentinel lymph node biopsy at diagnosis. Given its rarity, diagnostic complexities, and aggressive behavior, PC warrants a collaborative approach to maximize patient outcomes.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Hannah J Porter, Nadeem Marghoob, Hayden Christensen, Matthew Dinehart, Conor O'Neill, Mark Wick, Laura Greene, Christine H Weinbergerhttps://skin.dermsquared.com/skin/article/view/2773Improvement of Suspected Linear Morphea seen with Topical Ruxolitinib2024-09-02T19:49:38+00:00Shivkar Amarashivkar.amara@mountsinai.orgMiyahra Lopezmiyahra.lopez@mountsinai.orgMark Lebwohlmark.lebwohl@mountsinai.org<p style="font-weight: 400;">Linear morphea is an autoimmune skin condition characterized by localized sclerosis and discoloration. Current standard of care includes topical and intralesional steroids, phototherapy, and immunosuppressive agents; however, no gold-standard treatment exists. We present a 34-year-old female who presented with a hypopigmented and indurated plaque in an en coup de sabre configuration on her forehead, suspicious of linear morphea, that improved significantly in thickness and hypopigmentation after eight weeks of 1.5% ruxolitinib cream.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Shivkar Amara, Miyahra Lopez, Mark Lebwohlhttps://skin.dermsquared.com/skin/article/view/2681Clinical Improvement of Necrobiosis Lipoidica Diabeticorum with Opzelura (Ruxolitinib) Cream: A Case Report2024-09-02T20:40:28+00:00Annie Vuannie.vu@westernu.eduCheldon Alcantaraannie.vu@westernu.eduDiem Q. Phamannie.vu@westernu.edu<p>Necrobiosis lipoidica (NL) is an idiopathic granulomatous, inflammatory skin disorder, traditionally linked to diabetes mellitus but often occurs independently of glucose metabolism abnormalities. Proposed pathogenic mechanisms include microangiopathy, collagen devitalization, metabolic changes, trauma, and immune dysregulation. Management of NL is limited by data on treatment efficacy but includes high-potency topical steroids, intralesional steroids, topical immunomodulators, psoralen-ultraviolet A photochemotherapy, hydroxychloroquine, or TNF-alpha inhibitors, pentoxifylline, topical ALA-PDT, and more recently Janus kinase (JAK) inhibitors. This case discusses a 66-year-old female with type 2 diabetes that presents with necrobiosis lipiodica diabeticorum (NLD) who was refractory to high-potency topical corticosteroid but showed improvement after use of Opzelura cream.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Annie Vu, Cheldon Alcantara, Diem Q. Phamhttps://skin.dermsquared.com/skin/article/view/3205A Rare Case of Pemphigoid Gestationis 2025-01-07T16:42:27+00:00Sonia Patelpatels129@rowan.eduLauren Okonlauren.okon@mpderm.com<p>Pemphigoid gestationis (PG) is a condition that arises in pregnant women, typically presenting with pruritic and urticarial plaques and/or bullae involving the umbilicus. This report discusses a 36-year-old woman, 26 weeks pregnant, who presented with an intensely pruritic rash that spread from her thighs to her abdomen, forearms, and toe. Physical examination revealed annular pink papules and plaques, notably lacking bullae and sparing the umbilicus. Biopsy and direct immunofluorescence confirmed PG as well as the presence of serum BP180 antibodies. She responded well to clobetasol and cetirizine, and due to preeclampsia delivered preterm. PG is a rare condition that must be considered in pregnant patients promptly in order to avoid complications for both the mother and child.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Sonia Patel, Lauren Okonhttps://skin.dermsquared.com/skin/article/view/2918Representation and Quality of Acne-Related Content on Social Media2024-07-31T18:30:41+00:00Samantha Zoltansamanthamzoltan@gmail.comNanette Silverbergnanette.silverberg@mountsinai.org<p>Acne is a common dermatological condition affecting individuals of all races and ethnicities, with most cases occurring in teenagers and young adults. Patients in these age groups frequently turn to online platforms for guidance, relying on videos on social media platforms like TikTok. This study evaluated the top TikTok videos' content quality (DISCERN score) about perceived racial/ ethnic diversity. Findings demonstrate that videos showcasing the skin of individuals of color tend to have lower scientific content and potentially feature the application of agents that would promote dyspigmentation and scarring. There is a need to improve acne-related social media posts to provide higher-quality content targeted at patients of color, focusing on safer therapeutics.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Samantha Zoltan, Nanette Silverberghttps://skin.dermsquared.com/skin/article/view/2985Alopecia Areata and Vitamin D3 Deficiency: The Potential of Calcipotriol as a Treatment2024-11-04T15:00:34+00:00Michał Majewskimichalmajewski137@gmail.com<p style="font-weight: 400;"><strong>Background:</strong> Alopecia areata is a non-scarring form of hair loss associated with the loss of the hair follicle immune privilege with a prevalence of 2% in the population. It results in an accumulation of lymphocytes around the lower part of the hair bulb ultimately leading to hair loss.</p> <p style="font-weight: 400;"><strong>Discussion: </strong>Vitamin D<sub>3</sub> deficiency is significantly more prevalent in patients with alopecia areata than in healthy populations and correlates with disease severity. Screening patients with alopecia areata for vitamin D<sub>3</sub> deficiency could be beneficial, potentially allowing for supplementation. The pathogenic involvement of vitamin D<sub>3</sub> in alopecia areata is attributed to its regulatory impact on immune and epidermal cells’ function, particularly through modulation of the JAK/STAT pathway, T lymphocytes proliferation and hair follicle damage.</p> <p style="font-weight: 400;"><strong>Conclusion: </strong>The data on the effectiveness of vitamin D3 supplementation and topical calcipotriol in treating alopecia areata are inconsistent, and the evidence supporting their efficacy is primarily of low quality. This article underscores the need for randomized, placebo-controlled studies with large patient cohorts to evaluate the efficacy of calcipotriol in the treatment of alopecia areata.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Michał Majewskihttps://skin.dermsquared.com/skin/article/view/3210The Role of Image-Guided Superficial Radiation Therapy in the Treatment of Nonmelanoma Skin Cancer2025-01-07T01:32:58+00:00Danny Zakriadzakria13@gmail.comJoshua Burshteinjofskin@gmail.comMilaan Shahjofskin@gmail.comClay Cockerelljofskin@gmail.comGary Goldenbergjofskin@gmail.comMark Nestorjofskin@gmail.comDeborah Sarnoffjofskin@gmail.comSusan Weinklejofskin@gmail.comDarrell Rigeldarrell.rigel@gmail.comJames Q. Del Rossojqdelrosso@yahoo.com<p><strong>Background</strong>: Basal cell carcinoma (BCC) and squamous cell carcinoma, collectively referred to as nonmelanoma skin cancer (NMSC) are the most common type of skin cancer and can lead to significant morbidity and mortality. There are several treatment options available for NMSC including superficial radiation therapy (SRT), which has improved in recent years with the addition of image guidance (IGSRT). In some cases, patients are not offered IGSRT as a treatment option and additional guidance on its benefits may be beneficial.</p> <p><strong>Objective</strong>: For a panel of expert dermatologists to review published studies on IGSRT for the treatment NMSC and create consensus recommendations on its use.</p> <p><strong>Methods</strong>: A comprehensive literature search of PubMed, EMBASE, Scopus, and Google Scholar was completed for English-language original research articles on the use of IGSRT to treat NMSC. A panel of six dermatologists with significant expertise in treating NMSC convened to review the articles and create consensus statements based on the available data. A modified Delphi process was used to approve each statement for adoption and a strength of recommendation was assigned using Strength of Recommendation Taxonomy (SORT) criteria.</p> <p><strong>Results</strong>: After screening the articles that met the initial search criteria, 12 articles were distributed to the panelists for review prior to the roundtable discussion. The panel unanimously voted to adopt eight statements with an additional two statements receiving five out six votes for adoption. Eight of the statements received a strength of recommendation of “A” while two of the statements were given a strength of recommendation of “B” based on SORT criteria.</p> <p><strong>Conclusion</strong>: IGSRT is a safe and effective treatment for NMSC that often results in highly favorable cosmetic outcomes. It can be considered a first-line treatment option for appropriately selected cases of NMSC.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Danny Zakria, Joshua Burshtein, Milaan Shah, Clay Cockerell, Gary Goldenberg, Mark Nestor, Deborah Sarnoff, Susan Weinkle, Darrell Rigel, James Q. Del Rossohttps://skin.dermsquared.com/skin/article/view/2874Mixed Connective Tissue Disease Onset in the Setting of COVID Vaccination - Case Report and Recommendations2024-10-30T21:37:21+00:00Akber Sheikhakber.sheikh@westernu.eduAsim Godilasimagodil@gmail.comDiem Phamdpham@westernu.eduSuha Godilsuhagod@western.edu<p><strong>Background:</strong> As of 2024, the COVID-19 pandemic has infected over 700 million people resulting in over 7 million deaths worldwide. The vaccination has had significant controversy, partially implicated through a number of reported adverse events. Previous studies have suggested that vaccines can trigger autoimmune disease and the COVID-19 vaccine has been no exception to this. This study presents a case report and literature review exploring the potential link between the COVID-19 vaccination and autoimmune reactions.</p> <p><strong>Case Report:</strong> We present a previously healthy 28 year old male who developed a diffuse pruritic rash two weeks after receiving a booster Moderna vaccine for COVID-19. The patient, with a history of hypothyroidism and positive antinuclear antibody (ANA), exhibited pink erythematous, minimally scaly papules and plaques, predominantly on his hands, forearms, wrists, face, neck, and left shoulder. Subsequent workup revealed elevated anti-ribonucleoprotein (RNP) levels, leading to a diagnosis of mixed connective tissue disease (MCTD). This paper also features a review on cutaneous and systemic autoimmune conditions thought to be triggered by COVID-19 vaccines. Potential mechanisms are explored including molecular mimicry, bystander activation, and epitope spreading. Findings indicate that cutaneous reactions like dermatitis, urticaria, and morbilliform rashes are relatively common and can predispose more severe autoimmune conditions.</p> <p><strong>Conclusion: </strong>Implications of this study are the importance for medical professionals and patients to be wary of autoimmune reactions post-vaccination. Early recognition and management of these reactions is critical in ensuring patient safety, improving vaccination protocols, and maintaining public trust in vaccination programs and efforts.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Akber Sheikh, Asim Godil, Diem Pham, Suha Godilhttps://skin.dermsquared.com/skin/article/view/3072HPV and Genital Warts: Mapping Awareness Through Google Trends in the United States Trends2024-12-15T19:51:49+00:00Maci Terrellmaci.terrell@bcm.eduTheodore Rosenvampireted@aol.com<p><strong>Background:</strong> Human Papillomavirus is a sexually transmitted infection in the United States with an estimated 40% prevalence.</p> <p><strong>Methods:</strong> This study assessed Google Trends data for genital warts related search terms from 2004 to 2023. The latest Centers for Disease Control-reported National Immunization Survey for 2022 were compared to Google Trends data for patterns or correlations.</p> <p><strong>Results:</strong> Average annual searches for genital warts decreased by 73.7% from 2004 to 2023 with the largest reduction (-23.14%) occurring between 2019 and 2020. West Virginia had the highest twenty-year average searches for genital warts related search terms (94), while Utah was found to have the lowest. Minnesota, Massachusetts and Washington were reported on top ten states with the highest HPV vaccination coverage ( ≥ 1 dose) also were found on top ten states with the lowest twenty-year average Google Trend search inquiries for genital warts. Conversely, West Virginia, South Carolina, Oklahoma, Kentucky and Mississippi were found to be on the top ten states with the lowest reported ≥ 1 HPV dose vaccination coverage and among top ten states with highest genital wart searches. </p> <p><strong>Conclusion:</strong> Google Trends data can help identify at-risk regions and guide efforts to improve HPV vaccination rates in the United States.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Maci Terrell, Theodore Rosenhttps://skin.dermsquared.com/skin/article/view/3172Comparing Improvements in Biopsy Decision Making with Electrical Impedance Spectroscopy Between US and German Dermatologists2024-12-11T02:41:31+00:00Danny Zakriadzakria13@gmail.comNicholas Brownstonenickbrownstone34@gmail.comMilaan Shahmilaan8697@gmail.comJoshua Burshteinjburshtein13@gmail.comLauren DeBuskledebusk@gmail.comAngela Rosenbergangelarosenberg9@gmail.comDarrell Rigeldarrell.rigel@gmail.com<p>Electrical impedance spectroscopy (EIS) is a noninvasive tool that measures the electrophysical properties of pigmented lesions, generating a score to aid in the differentiation of benign and malignant lesions. This research letter compares two studies, conducted in the United States (US) and Germany, evaluating the impact of EIS on biopsy decision-making among dermatologists. Both studies used the same set of clinical and dermoscopic images along with EIS scores for 49 lesions. Findings revealed that American dermatologists had a higher rate of correct biopsy decisions for malignant melanomas (MMs) and severe dysplastic nevi (SDNs) compared to their German counterparts. However, German dermatologists showed greater accuracy in avoiding unnecessary biopsies of benign pigmented skin lesions (PSLs). The addition of both dermoscopy and EIS significantly improved biopsy decision accuracy for MMs and SDNs in both groups, with EIS further mitigating initial reductions in correct biopsy choices for benign lesions. Differences in practice patterns, training, and malpractice concerns may explain the observed variations between US and German dermatologists. These results underscore the utility of EIS as a complementary tool to dermoscopy, enhancing the accuracy of biopsy decisions and improving patient outcomes.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Danny Zakria, Nicholas Brownstone, Milaan Shah, Joshua Burshtein, Lauren DeBusk, Angela Rosenberg, Darrell Rigelhttps://skin.dermsquared.com/skin/article/view/2775Analyzing Inpatient Vaccine Reactions Amongst Systemic Lupus Erythematosus Patients in the COVID-19 Era: A National Analysis2024-09-02T20:30:03+00:00Amar D. Desaiamardesai95@gmail.comJennifer E. Yehjeyeh@stanford.edu<p style="font-weight: 400;"><strong>Introduction:</strong> Systemic lupus erythematosus (SLE) patient hospitalizations were areas of concern during the coronavirus of 2019 (COVID-19) and subsequent vaccine rollout. We aimed to characterize hospitalization trends nationally amongst SLE patients following COVID-19 vaccine rollout.</p> <p style="font-weight: 400;"><strong>Methods:</strong> The 2016-2020 Nationwide Inpatient Sample (NIS) was queried for SLE hospitalizations using International Classification of Diseases, Tenth Revision (ICD-10) code “M32”. SLE hospitalizations with co-morbid vaccine reactions (RX+) were identified using ICD-10 codes “T50.x”. Clinical and demographic features and rates of high-risk underlying co-morbidities were compared.</p> <p style="font-weight: 400;"><strong>Results: </strong>Among total SLE hospitalizations, 1.4% were RX+ between 2016-2020. RX+ patient hospitalizations increased from 2019-2020. RX+ patients exhibited a significantly higher burden of heart disease, chronic kidney disease (CKD), chronic liver or lung disease, HIV, and obesity.</p> <p style="font-weight: 400;"><strong>Discussion: </strong>Our findings suggest that RX+ SLE patients are slightly older, and have significantly greater proportions of comorbid conditions, namely heart disease, CKD, and diabetes compared to RX- SLE patients. Increased SLE severity may impart an inflammatory burden on patients not explained by immunosuppression alone, making them more susceptible to factors with shared pathogenic risks like vaccine reactions.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Amar D. Desai, Jennifer E. Yehhttps://skin.dermsquared.com/skin/article/view/2815The Safety Profile of Acne Supplements: Analysis of Active Ingredients2024-09-02T20:55:46+00:00Sasan Noveirdnoveir@mednet.ucla.eduJayden Galamgamjgalamgam@mednet.ucla.eduCarol Chengcecheng@mednet.ucla.edu<p><strong>Introduction</strong>: Acne treatment options vary widely, with many patients using dietary supplements. Despite their popularity, these products pose safety concerns due to lack of FDA approval for safety or efficacy before release. The US Institute of Medicine sets Tolerable Upper Intake Levels (ULs) for nutrients, but there are no regulatory limits to prevent supplements from exceeding these ULs.</p> <p><strong>Methods</strong>: On March 3, 2024, active ingredients from the top 50 best-selling acne supplements were collected from Amazon. Data were analyzed to identify ingredients and the frequency at which their dosages surpassed the ULs for different age groups.</p> <p><strong>Results</strong>: The most prevalent active ingredients were zinc (40%), vitamin A (30%), diindolylmethane (DIM) (26%), vitamin E (26%), and selenium (24%). Thirty percent of all supplements contained at least one ingredient exceeding its UL for ages 9 to 13, 20% for ages 14-18, and 16% for ages 19 and older. Twenty-five percent of zinc-containing supplements and 33% of vitamin A-containing supplements exceeded the UL for any all groups.</p> <p><strong>Discussion</strong>: Acne supplements frequently contain ingredients that surpass ULs, particularly zinc and vitamin A. Chronic toxicity from these nutrients can lead to significant health issues. Dermatologists should inquire about supplement use when prescribing treatments like isotretinoin to prevent toxicity risks.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Sasan Noveir, Jayden Galamgam, Carol Chenghttps://skin.dermsquared.com/skin/article/view/3029Prevalence of Sun-Protective Behaviors Among Medical Students: Insights from a Survey at the University of Texas Medical Branch2024-10-30T19:56:12+00:00Madelyn Schmidtmlschmid@utmb.eduAyezel Munoz Gonzalezammunozg@utmb.edu<p style="font-weight: 400;"><strong>Introduction:</strong> Skin cancer encompasses almost half of the cancers diagnosed in the United States and the majority are caused by excessive sun exposure. Studies have found minimal sunscreen use among medical students and physicians despite understanding the importance of its use. This survey aims to evaluate the prevalence of sun-protective behaviors among the University of Texas Medical Branch (UTMB) medical students.</p> <p style="font-weight: 400;"><strong>Methods:</strong> An anonymous survey assessed participants' demographic information, use of sun-protective measures, and weekly sun exposure from currently enrolled UTMB medical students.</p> <p style="font-weight: 400;"><strong>Results:</strong> Out of the 920 medical students currently enrolled at UTMB, surveys were completed by 171 medical students, 18.6% of the student population. Regarding sunscreen use, 119 students (69.6%) regularly apply sunscreen, and of those students, 68.9% apply sunscreen daily. The most common sunscreens used were between SPF 20-60, however, most respondents did not reapply sunscreen (63.9%). Most participants were outside for one-three hours without shade covering (59.6%), did not wear protective clothing (65.5%), and did not get sunburned in the previous week (97.1%).</p> <p style="font-weight: 400;"><strong>Discussion:</strong> Our results demonstrate increased sunscreen use among medical students compared to previously reported literature, however, most students did not wear sun-protective clothing or reapply sunscreen. Proper sun safety education in medical school has been shown to increase the likelihood of future sun-safety-related patient counseling. Addressing skin-protective measures in medical school can decrease the risk of skin cancer among medical students and their future patients. Future interventions can aim to educate medical students on sun safety.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Madelyn Schmidt, Ayezel Munoz Gonzalezhttps://skin.dermsquared.com/skin/article/view/3005A Five-year Consumer Protection Database Study Yielded Emergent Demographic and Dermatological Condition Information Associated with Rock Climbing for One Hundred and Sixty-Six Patients 2024-10-15T17:45:15+00:00Ryan Scheinkmanscheinkman@med.miami.eduAnika Pulumatiapulumati072@gmail.comPhilippe Jean-Pierrephilanator@med.miami.eduKayla Mashoudykmashoudy@med.miami.eduKeyvan Nouriknouri@miami.edu<p style="font-weight: 400;"><strong>Introduction:</strong> Rock climbing is a popular activity that poses various injury risks, including falls, equipment failures, physical stress from climbing, and contact with falling objects. We aimed to quantify emergent dermatological injuries and conditions</p> <p style="font-weight: 400;"><strong>Methods:</strong> We used the NEISS database that collates data from over 100 emergency rooms and applied filters to analyze rock climbing injury and skin condition data from 2019 and 2023 for demographics, anatomical location, and types of injuries and conditions.</p> <p style="font-weight: 400;"><strong>Results:</strong> A total of 166 patient vignettes with 186 injuries were included. The majority of the climbers with dermatological injuries were male (64%), with the most common injuries found to be contusions or abrasions (n = 109) and the most common injury sites being the upper extremities (n = 61) and the head/neck (n = 50).</p> <p style="font-weight: 400;"><strong>Discussion:</strong> These results emphasize the need for targeted preventive measures to reduce the incidence of dermatological injuries among rock climbers, considering that the severity and impact of these injuries can be significant (e.g., lacerations) and prevalent in cosmetically sensitive areas (head/neck). Additional research should also be performed at ambulatory and outpatient settings to identify less emergent dermatological conditions associated with the sport and allow for appropriate guidance for those conditions. </p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Ryan Scheinkman, Anika Pulumati, Philippe Jean-Pierre, Kayla Mashoudy, Keyvan Nourihttps://skin.dermsquared.com/skin/article/view/3178The Rise of TikTok Facial Filler Influencers: Implications for Demand and Practice2025-01-03T17:20:08+00:00Sheila Sharifiss4647@georgetown.eduIsabel Rodriguezixr294@miami.eduLauren Denderldender@med.miami.eduKeyvan Nouriknouri@med.miami.edu<p><strong>Background:</strong> This study seeks to analyze online engagement with established TikTok accounts sharing public information about facial fillers and compare these trends with reported industry demand for fillers in 2023.</p> <p><strong>Methods: </strong>Relevant TikTok accounts with a focus on facial fillers and aesthetics were identified, with account followers, video likes, and uploads in 2023 measured. Accounts included in our study had to be currently active and English-speaking, with particular attention to high follower accounts (e.g. greater than 20,000 followers).</p> <p><strong>Results: </strong>The TikTok accounts analyzed collectively had 1,659,300 online followers with a 11% increase in followers in 2023. Additionally, the total number of likes increased by 6,408,800 and total video content uploads increased by 1,362.</p> <p><strong>Conclusion: </strong>According to industry data, there was an 8% increase in filler procedures performed in 2023 suggesting that increased demand may coincide with heightened social media exposure. Due to growing concern over misinformation and a lack of accredited content, the sharing and support of qualified educational material should be emphasized.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Sheila Sharifi, Isabel Rodriguez, Lauren Dender, Keyvan Nourihttps://skin.dermsquared.com/skin/article/view/3148 Post-Hoc Analyses Support Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Uncontrolled Eosinophilic Asthma and Prior Exacerbations2024-11-19T15:13:27+00:00Jonathan Correnjofskin@gmail.comStanley J. Szeflerjofskin@gmail.comEllen Sherjofskin@gmail.comPhillip Korenblatjofskin@gmail.comWeily Soongjofskin@gmail.comNicola A. Hananiajofskin@gmail.comGary Bermanjofskin@gmail.comGuy Brussellejofskin@gmail.comRalph Zitnikjofskin@gmail.comChitra R. Nataliejofskin@gmail.comKimberly Siujofskin@gmail.comWen-Shuo Wujofskin@gmail.comMeihua Qiaojofskin@gmail.comPeter Liojofskin@gmail.comApril W. Armstrongjofskin@gmail.com<p><strong><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW46302027 BCX8">Introduction</span><span class="NormalTextRun SCXW46302027 BCX8">:</span></span></strong><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"> <span class="NormalTextRun SCXW46302027 BCX8">Lebrikizumab, a novel, high-affinity monoclonal antibody selectively targeting </span><span class="NormalTextRun SCXW46302027 BCX8">interleukin</span><span class="NormalTextRun SCXW46302027 BCX8">-13, has </span></span><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW46302027 BCX8">demonstrated</span> <span class="NormalTextRun SCXW46302027 BCX8">efficacy</span><span class="NormalTextRun SCXW46302027 BCX8"> and safety</span><span class="NormalTextRun SCXW46302027 BCX8"> in </span><span class="NormalTextRun SCXW46302027 BCX8">moderate-to-severe </span><span class="NormalTextRun SCXW46302027 BCX8">at</span><span class="NormalTextRun SCXW46302027 BCX8">opic dermatitis</span><span class="NormalTextRun SCXW46302027 BCX8"> at higher doses than </span><span class="NormalTextRun SCXW46302027 BCX8">studied in</span> <span class="NormalTextRun SCXW46302027 BCX8">asthma</span></span><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW46302027 BCX8">.</span> <span class="NormalTextRun SCXW46302027 BCX8">C</span><span class="NormalTextRun SCXW46302027 BCX8">linical trials of lebrikizumab</span><span class="NormalTextRun SCXW46302027 BCX8"> in </span><span class="NormalTextRun SCXW46302027 BCX8">moderate-to-severe uncontrolled </span><span class="NormalTextRun SCXW46302027 BCX8">asthma</span><span class="NormalTextRun SCXW46302027 BCX8"> have not </span><span class="NormalTextRun SCXW46302027 BCX8">demonstrated</span><span class="NormalTextRun SCXW46302027 BCX8"> consistent</span><span class="NormalTextRun SCXW46302027 BCX8"> exacerbation</span><span class="NormalTextRun SCXW46302027 BCX8"> reductions, </span><span class="NormalTextRun SCXW46302027 BCX8">possibly due</span><span class="NormalTextRun SCXW46302027 BCX8"> to suboptimal patient selection</span> <span class="NormalTextRun SCXW46302027 BCX8">and </span><span class="NormalTextRun SCXW46302027 BCX8">premature understanding of asthma phenotypes</span><span class="NormalTextRun SCXW46302027 BCX8">.</span> <span class="NormalTextRun SCXW46302027 BCX8">We describe</span><span class="NormalTextRun SCXW46302027 BCX8"> post-hoc an</span><span class="NormalTextRun SCXW46302027 BCX8">a</span><span class="NormalTextRun SCXW46302027 BCX8">lyses</span><span class="NormalTextRun SCXW46302027 BCX8"> in </span><span class="NormalTextRun SCXW46302027 BCX8">adults with uncontrolled </span><span class="NormalTextRun SCXW46302027 BCX8">eosinophilic </span><span class="NormalTextRun SCXW46302027 BCX8">asthma </span><span class="NormalTextRun SCXW46302027 BCX8">with a </span><span class="NormalTextRun SCXW46302027 BCX8">history of </span><span class="NormalTextRun SCXW46302027 BCX8">≥</span><span class="NormalTextRun SCXW46302027 BCX8">1 </span><span class="NormalTextRun SCXW46302027 BCX8">asthma exacerbation</span> <span class="NormalTextRun SCXW46302027 BCX8">in</span><span class="NormalTextRun SCXW46302027 BCX8"> the</span><span class="NormalTextRun SCXW46302027 BCX8"> past 12 </span></span><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW46302027 BCX8">months</span><span class="NormalTextRun SCXW46302027 BCX8"> from </span><span class="NormalTextRun SCXW46302027 BCX8">2 </span><span class="NormalTextRun SCXW46302027 BCX8">phase 3 </span><span class="NormalTextRun SCXW46302027 BCX8">lebrikizumab </span><span class="NormalTextRun SCXW46302027 BCX8">clinical trials (LAVOLTA I and II)</span><span class="NormalTextRun SCXW46302027 BCX8"> completed in 20</span><span class="NormalTextRun SCXW46302027 BCX8">16</span><span class="NormalTextRun SCXW46302027 BCX8">.</span> </span></p> <p><strong><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW46302027 BCX8">Methods</span><span class="NormalTextRun SCXW46302027 BCX8">:</span></span></strong><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW46302027 BCX8"> Patients</span><span class="NormalTextRun SCXW46302027 BCX8"> were randomly assigned to</span><span class="NormalTextRun SCXW46302027 BCX8"> receive </span><span class="NormalTextRun SCXW46302027 BCX8">lebrikizumab </span><span class="NormalTextRun SCXW46302027 BCX8">(</span><span class="NormalTextRun SCXW46302027 BCX8">37.5mg</span><span class="NormalTextRun SCXW46302027 BCX8"> or</span> <span class="NormalTextRun SCXW46302027 BCX8">1</span><span class="NormalTextRun SCXW46302027 BCX8">25</span><span class="NormalTextRun SCXW46302027 BCX8">mg</span><span class="NormalTextRun SCXW46302027 BCX8">)</span><span class="NormalTextRun SCXW46302027 BCX8">, </span><span class="NormalTextRun SCXW46302027 BCX8">or placebo</span> <span class="NormalTextRun SCXW46302027 BCX8">(</span><span class="NormalTextRun SCXW46302027 BCX8">all </span><span class="NormalTextRun SCXW46302027 BCX8">N</span><span class="NormalTextRun SCXW46302027 BCX8">=</span><span class="NormalTextRun SCXW46302027 BCX8">716</span><span class="NormalTextRun SCXW46302027 BCX8">) </span><span class="NormalTextRun SCXW46302027 BCX8">every 4</span><span class="NormalTextRun SCXW46302027 BCX8"> </span><span class="NormalTextRun SCXW46302027 BCX8">weeks</span><span class="NormalTextRun SCXW46302027 BCX8">. </span><span class="NormalTextRun SCXW46302027 BCX8">A</span><span class="NormalTextRun SCXW46302027 BCX8">djusted exacerbation rate</span><span class="NormalTextRun SCXW46302027 BCX8"> (AER)</span><span class="NormalTextRun SCXW46302027 BCX8"> at </span><span class="NormalTextRun SCXW46302027 BCX8">w</span><span class="NormalTextRun SCXW46302027 BCX8">eek 52</span><span class="NormalTextRun SCXW46302027 BCX8"> (W52)</span><span class="NormalTextRun SCXW46302027 BCX8">, </span><span class="NormalTextRun SCXW46302027 BCX8">presented as </span><span class="NormalTextRun SCXW46302027 BCX8">rate reduction</span><span class="NormalTextRun SCXW46302027 BCX8">,</span><span class="NormalTextRun SCXW46302027 BCX8"> and </span><span class="NormalTextRun SCXW46302027 BCX8">placebo</span><span class="NormalTextRun SCXW46302027 BCX8">-corrected </span><span class="NormalTextRun SCXW46302027 BCX8">mean </span><span class="NormalTextRun SCXW46302027 BCX8">change in prebronchodilator forced expiratory </span><span class="NormalTextRun SCXW46302027 BCX8">volume in 1</span><span class="NormalTextRun SCXW46302027 BCX8"> </span><span class="NormalTextRun SCXW46302027 BCX8">second (FEV</span></span><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="none"><span class="NormalTextRun Subscript SCXW46302027 BCX8" data-fontsize="12">1</span></span><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW46302027 BCX8">)</span> <span class="NormalTextRun SCXW46302027 BCX8">at </span><span class="NormalTextRun SCXW46302027 BCX8">w</span><span class="NormalTextRun SCXW46302027 BCX8">eek</span><span class="NormalTextRun SCXW46302027 BCX8">s</span><span class="NormalTextRun SCXW46302027 BCX8"> 24</span><span class="NormalTextRun SCXW46302027 BCX8"> (W24)</span><span class="NormalTextRun SCXW46302027 BCX8"> and 52</span><span class="NormalTextRun SCXW46302027 BCX8"> were assessed in </span><span class="NormalTextRun SCXW46302027 BCX8">patients </span><span class="NormalTextRun SCXW46302027 BCX8">with </span><span class="NormalTextRun SCXW46302027 BCX8">elevated fractional exhaled nitric oxide (</span><span class="NormalTextRun SpellingErrorV2Themed SCXW46302027 BCX8">FeNO</span> <span class="NormalTextRun SCXW46302027 BCX8">[</span><span class="NormalTextRun SCXW46302027 BCX8">≥50 mean p</span><span class="NormalTextRun SCXW46302027 BCX8">arts per billion</span><span class="NormalTextRun SCXW46302027 BCX8">]</span><span class="NormalTextRun SCXW46302027 BCX8">; </span><span class="NormalTextRun SCXW46302027 BCX8">37.5mg </span><span class="NormalTextRun SCXW46302027 BCX8">[</span><span class="NormalTextRun SCXW46302027 BCX8">n=</span><span class="NormalTextRun SCXW46302027 BCX8">105</span><span class="NormalTextRun SCXW46302027 BCX8">]</span><span class="NormalTextRun SCXW46302027 BCX8">, 125mg </span><span class="NormalTextRun SCXW46302027 BCX8">[</span><span class="NormalTextRun SCXW46302027 BCX8">n=</span><span class="NormalTextRun SCXW46302027 BCX8">107</span><span class="NormalTextRun SCXW46302027 BCX8">]</span><span class="NormalTextRun SCXW46302027 BCX8">, </span><span class="NormalTextRun SCXW46302027 BCX8">placebo</span> <span class="NormalTextRun SCXW46302027 BCX8">[</span><span class="NormalTextRun SCXW46302027 BCX8">n=</span><span class="NormalTextRun SCXW46302027 BCX8">109</span><span class="NormalTextRun SCXW46302027 BCX8">]</span><span class="NormalTextRun SCXW46302027 BCX8">)</span> <span class="NormalTextRun SCXW46302027 BCX8">and </span><span class="NormalTextRun SCXW46302027 BCX8">in </span><span class="NormalTextRun SCXW46302027 BCX8">those </span><span class="NormalTextRun SCXW46302027 BCX8">with </span><span class="NormalTextRun SCXW46302027 BCX8">both </span><span class="NormalTextRun SCXW46302027 BCX8">elevated </span><span class="NormalTextRun SpellingErrorV2Themed SCXW46302027 BCX8">FeNO</span> <span class="NormalTextRun SCXW46302027 BCX8">and </span><span class="NormalTextRun SCXW46302027 BCX8">elevated blood eosinophils (</span><span class="NormalTextRun SCXW46302027 BCX8">≥300 cells/µL</span><span class="NormalTextRun SCXW46302027 BCX8">; </span><span class="NormalTextRun SCXW46302027 BCX8">37.5mg </span><span class="NormalTextRun SCXW46302027 BCX8">[</span><span class="NormalTextRun SCXW46302027 BCX8">n=</span><span class="NormalTextRun SCXW46302027 BCX8">60</span><span class="NormalTextRun SCXW46302027 BCX8">]</span><span class="NormalTextRun SCXW46302027 BCX8">, 125mg </span><span class="NormalTextRun SCXW46302027 BCX8">[</span><span class="NormalTextRun SCXW46302027 BCX8">n=</span><span class="NormalTextRun SCXW46302027 BCX8">66</span><span class="NormalTextRun SCXW46302027 BCX8">]</span><span class="NormalTextRun SCXW46302027 BCX8">, </span><span class="NormalTextRun SCXW46302027 BCX8">placebo</span> <span class="NormalTextRun SCXW46302027 BCX8">[</span><span class="NormalTextRun SCXW46302027 BCX8">n=</span><span class="NormalTextRun SCXW46302027 BCX8">62</span><span class="NormalTextRun SCXW46302027 BCX8">]</span><span class="NormalTextRun SCXW46302027 BCX8">)</span> <span class="NormalTextRun SCXW46302027 BCX8">at baseline</span><span class="NormalTextRun SCXW46302027 BCX8">.</span></span></p> <p><strong><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW46302027 BCX8">Results</span><span class="NormalTextRun SCXW46302027 BCX8">:</span></span></strong><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"> <span class="NormalTextRun SCXW46302027 BCX8">L</span><span class="NormalTextRun SCXW46302027 BCX8">ebrikizumab </span><span class="NormalTextRun SCXW46302027 BCX8">significantly </span><span class="NormalTextRun SCXW46302027 BCX8">reduced</span> <span class="NormalTextRun SCXW46302027 BCX8">the </span><span class="NormalTextRun SCXW46302027 BCX8">AER</span> <span class="NormalTextRun SCXW46302027 BCX8">versus</span> <span class="NormalTextRun SCXW46302027 BCX8">placebo </span><span class="NormalTextRun SCXW46302027 BCX8">at </span><span class="NormalTextRun SCXW46302027 BCX8">W</span><span class="NormalTextRun SCXW46302027 BCX8">52</span><span class="NormalTextRun SCXW46302027 BCX8"> in </span><span class="NormalTextRun SCXW46302027 BCX8">the</span><span class="NormalTextRun SCXW46302027 BCX8"> elevated </span><span class="NormalTextRun SpellingErrorV2Themed SCXW46302027 BCX8">FeNO</span> <span class="NormalTextRun SCXW46302027 BCX8">(37.5mg</span><span class="NormalTextRun SCXW46302027 BCX8">,</span> <span class="NormalTextRun SCXW46302027 BCX8">47.5</span><span class="NormalTextRun SCXW46302027 BCX8">%</span><span class="NormalTextRun SCXW46302027 BCX8">;</span><span class="NormalTextRun SCXW46302027 BCX8"> 125mg</span><span class="NormalTextRun SCXW46302027 BCX8">,</span> <span class="NormalTextRun SCXW46302027 BCX8">45.5</span><span class="NormalTextRun SCXW46302027 BCX8">%)</span><span class="NormalTextRun SCXW46302027 BCX8"> and </span><span class="NormalTextRun SCXW46302027 BCX8">elevated</span> <span class="NormalTextRun SpellingErrorV2Themed SCXW46302027 BCX8">FeNO</span> <span class="NormalTextRun SCXW46302027 BCX8">and </span><span class="NormalTextRun SCXW46302027 BCX8">blood </span><span class="NormalTextRun SCXW46302027 BCX8">eosinophils (37.5mg</span><span class="NormalTextRun SCXW46302027 BCX8">,</span><span class="NormalTextRun SCXW46302027 BCX8"> 52.3%</span><span class="NormalTextRun SCXW46302027 BCX8">;</span><span class="NormalTextRun SCXW46302027 BCX8"> 125mg</span><span class="NormalTextRun SCXW46302027 BCX8">,</span><span class="NormalTextRun SCXW46302027 BCX8"> 52.</span><span class="NormalTextRun SCXW46302027 BCX8">9</span><span class="NormalTextRun SCXW46302027 BCX8">%)</span><span class="NormalTextRun SCXW46302027 BCX8"> subgroup</span><span class="NormalTextRun SCXW46302027 BCX8">s</span><span class="NormalTextRun SCXW46302027 BCX8">. </span><span class="NormalTextRun SCXW46302027 BCX8">S</span><span class="NormalTextRun SCXW46302027 BCX8">ignificant FEV</span></span><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun Subscript SCXW46302027 BCX8" data-fontsize="12">1</span></span><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"> <span class="NormalTextRun SCXW46302027 BCX8">improvement </span><span class="NormalTextRun SCXW46302027 BCX8">was </span><span class="NormalTextRun SCXW46302027 BCX8">o</span><span class="NormalTextRun SCXW46302027 BCX8">bserved</span> <span class="NormalTextRun SCXW46302027 BCX8">in patients </span><span class="NormalTextRun SCXW46302027 BCX8">with</span></span> <span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW46302027 BCX8">elevated </span><span class="NormalTextRun SpellingErrorV2Themed SCXW46302027 BCX8">FeNO</span> <span class="NormalTextRun SCXW46302027 BCX8">at </span><span class="NormalTextRun SCXW46302027 BCX8">W</span><span class="NormalTextRun SCXW46302027 BCX8">24 </span><span class="NormalTextRun SCXW46302027 BCX8">(</span><span class="NormalTextRun SCXW46302027 BCX8">improvement for </span><span class="NormalTextRun SCXW46302027 BCX8">37.5mg</span><span class="NormalTextRun SCXW46302027 BCX8">,</span> <span class="NormalTextRun SCXW46302027 BCX8">205.4</span><span class="NormalTextRun SCXW46302027 BCX8">m</span><span class="NormalTextRun SCXW46302027 BCX8">L</span><span class="NormalTextRun SCXW46302027 BCX8">;</span><span class="NormalTextRun SCXW46302027 BCX8"> 125mg</span><span class="NormalTextRun SCXW46302027 BCX8">,</span> <span class="NormalTextRun SCXW46302027 BCX8">240.9</span><span class="NormalTextRun SCXW46302027 BCX8">m</span><span class="NormalTextRun SCXW46302027 BCX8">L</span><span class="NormalTextRun SCXW46302027 BCX8">) </span><span class="NormalTextRun SCXW46302027 BCX8">a</span><span class="NormalTextRun SCXW46302027 BCX8">nd </span><span class="NormalTextRun SCXW46302027 BCX8">W</span><span class="NormalTextRun SCXW46302027 BCX8">52</span> <span class="NormalTextRun SCXW46302027 BCX8">(37.5mg</span><span class="NormalTextRun SCXW46302027 BCX8">,</span> <span class="NormalTextRun SCXW46302027 BCX8">189.8</span><span class="NormalTextRun SCXW46302027 BCX8">m</span><span class="NormalTextRun SCXW46302027 BCX8">L</span><span class="NormalTextRun SCXW46302027 BCX8">;</span><span class="NormalTextRun SCXW46302027 BCX8"> 125mg</span><span class="NormalTextRun SCXW46302027 BCX8">,</span> <span class="NormalTextRun SCXW46302027 BCX8">212.0</span><span class="NormalTextRun SCXW46302027 BCX8">m</span><span class="NormalTextRun SCXW46302027 BCX8">L</span><span class="NormalTextRun SCXW46302027 BCX8">)</span><span class="NormalTextRun SCXW46302027 BCX8">.</span> <span class="NormalTextRun SCXW46302027 BCX8">In patients with elevat</span><span class="NormalTextRun SCXW46302027 BCX8">ed </span><span class="NormalTextRun SpellingErrorV2Themed SCXW46302027 BCX8">FeNO</span> <span class="NormalTextRun SCXW46302027 BCX8">and </span><span class="NormalTextRun SCXW46302027 BCX8">elevated </span><span class="NormalTextRun SCXW46302027 BCX8">blood </span><span class="NormalTextRun SCXW46302027 BCX8">eosinophils, </span><span class="NormalTextRun SCXW46302027 BCX8">FEV</span></span><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun Subscript SCXW46302027 BCX8" data-fontsize="12">1</span></span><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"> <span class="NormalTextRun SCXW46302027 BCX8">significantly improved at </span><span class="NormalTextRun SCXW46302027 BCX8">W</span><span class="NormalTextRun SCXW46302027 BCX8">24 (37.5mg</span><span class="NormalTextRun SCXW46302027 BCX8">,</span> <span class="NormalTextRun SCXW46302027 BCX8">274.8</span><span class="NormalTextRun SCXW46302027 BCX8">m</span><span class="NormalTextRun SCXW46302027 BCX8">L</span><span class="NormalTextRun SCXW46302027 BCX8">;</span><span class="NormalTextRun SCXW46302027 BCX8"> 125mg</span><span class="NormalTextRun SCXW46302027 BCX8">,</span> <span class="NormalTextRun SCXW46302027 BCX8">234.1</span><span class="NormalTextRun SCXW46302027 BCX8">m</span><span class="NormalTextRun SCXW46302027 BCX8">L</span><span class="NormalTextRun SCXW46302027 BCX8">)</span><span class="NormalTextRun SCXW46302027 BCX8"> and </span><span class="NormalTextRun SCXW46302027 BCX8">for </span><span class="NormalTextRun SCXW46302027 BCX8">the </span><span class="NormalTextRun SCXW46302027 BCX8">lower dose</span><span class="NormalTextRun SCXW46302027 BCX8"> at </span><span class="NormalTextRun SCXW46302027 BCX8">W</span><span class="NormalTextRun SCXW46302027 BCX8">52</span><span class="NormalTextRun SCXW46302027 BCX8"> (</span><span class="NormalTextRun SCXW46302027 BCX8">37.5mg, </span><span class="NormalTextRun SCXW46302027 BCX8">209.5m</span><span class="NormalTextRun SCXW46302027 BCX8">L</span><span class="NormalTextRun SCXW46302027 BCX8">)</span><span class="NormalTextRun SCXW46302027 BCX8">, </span><span class="NormalTextRun SCXW46302027 BCX8">while </span><span class="NormalTextRun SCXW46302027 BCX8">a numeric </span><span class="NormalTextRun SCXW46302027 BCX8">increase</span> <span class="NormalTextRun SCXW46302027 BCX8">was </span><span class="NormalTextRun SCXW46302027 BCX8">observed</span> <span class="NormalTextRun SCXW46302027 BCX8">for the higher dose</span><span class="NormalTextRun SCXW46302027 BCX8"> (</span><span class="NormalTextRun SCXW46302027 BCX8">125mg</span><span class="NormalTextRun SCXW46302027 BCX8">,</span> <span class="NormalTextRun SCXW46302027 BCX8">139.2</span><span class="NormalTextRun SCXW46302027 BCX8">m</span><span class="NormalTextRun SCXW46302027 BCX8">L</span><span class="NormalTextRun SCXW46302027 BCX8">). </span></span></p> <p><strong><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW46302027 BCX8">Conclusion</span><span class="NormalTextRun SCXW46302027 BCX8">:</span></span></strong><span class="TextRun SCXW46302027 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW46302027 BCX8"> </span><span class="NormalTextRun SCXW46302027 BCX8">L</span><span class="NormalTextRun SCXW46302027 BCX8">ebrikizumab could be beneficial in </span><span class="NormalTextRun SCXW46302027 BCX8">patients with </span><span class="NormalTextRun SCXW46302027 BCX8">uncontrolled </span><span class="NormalTextRun SCXW46302027 BCX8">asthma </span><span class="NormalTextRun SCXW46302027 BCX8">with</span> <span class="NormalTextRun SCXW46302027 BCX8">type 2 </span><span class="NormalTextRun SCXW46302027 BCX8">inflammation (elevated </span><span class="NormalTextRun SpellingErrorV2Themed SCXW46302027 BCX8">FeNO</span><span class="NormalTextRun SCXW46302027 BCX8"> and/or </span><span class="NormalTextRun SCXW46302027 BCX8">elevated </span><span class="NormalTextRun SCXW46302027 BCX8">blood </span><span class="NormalTextRun SCXW46302027 BCX8">eosinophils) and a</span> <span class="NormalTextRun SCXW46302027 BCX8">history of</span> <span class="NormalTextRun SCXW46302027 BCX8">recent </span><span class="NormalTextRun SCXW46302027 BCX8">exacerbations</span><span class="NormalTextRun SCXW46302027 BCX8">.</span><span class="NormalTextRun SCXW46302027 BCX8"> </span></span><span class="EOP SCXW46302027 BCX8" data-ccp-props="{"201341983":0,"335559739":120,"335559740":240}"> </span></p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Jonathan Corren, Stanley J. Szefler, Ellen Sher, Phillip Korenblat, Weily Soong, Nicola A. Hanania, Gary Berman, Guy Brusselle, Ralph Zitnik, Chitra R. Natalie, Kimberly Siu, Wen-Shuo Wu, Meihua Qiao, Peter Lio, April W. Armstronghttps://skin.dermsquared.com/skin/article/view/3163Baricitinib Achieved Complete/Near Complete Scalp Coverage in SALT Score ≤20 Responders: 52-Week Findings From BRAVE-AA Trials2024-11-25T10:49:47+00:00Justin Kojofskin@gmail.comAmy McMichaeljofskin@gmail.comMaria Hordinskyjofskin@gmail.comThierry Passeronjofskin@gmail.comYutaka Shimomurajofskin@gmail.comSamuel Ogwujofskin@gmail.comRukhsar Chughtaijofskin@gmail.comNajwa Somanijofskin@gmail.comBrett Kingjofskin@gmail.com<p><strong><span data-contrast="auto">Introduction:</span></strong><span data-contrast="auto"> Baricitinib is an approved and widely used treatment option for severe alopecia areata (AA). In the Phase 2/3 BRAVE-AA1 (NCT03570749) and Phase 3 BRAVE-AA2 (NCT03899259) trials, a significant proportion of patients achieved the clinically meaningful endpoint of Severity of Alopecia Tool (SALT) score ≤20, and maintained it through Week 52. While SALT score ≤20 is a standard endpoint, it does not capture the full extent of patient improvement among responders. Many patients who achieved SALT score ≤20 in the BRAVE-AA trials, also achieved complete or nearly complete scalp coverage (SALT score ≤10 or ≤5). The objective of this analysis was to evaluate the proportion of patients achieving SALT score ≤10 or ≤5 among patients treated with baricitinib who achieved SALT score ≤20 through Week 52. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto">Methods:</span></strong><span data-contrast="auto"> This analysis evaluated the proportion of patients achieving SALT score ≤10 or ≤5 among patients with severe AA pooled from the two BRAVE-AA trials who achieved SALT score ≤20 after treatment with baricitinib 4-mg or 2-mg at Weeks (W) 4, 8, 12, 16, 24, 36, and 52. Baseline demographics were evaluated to assess potential differences between patients with different levels of response. As-observed analyses used all collected data. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto">Results</span></strong><span data-contrast="auto">: Among patients treated with baricitinib 4-mg, the proportions of SALT score ≤20 </span><span data-contrast="auto">responders who achieved </span><span data-contrast="auto">SALT score ≤10 at W4, 8, 12, 16, 24, 36, and 52 were 0% (0/2), 44.4% (8/18), 46.0% (23/50), 52.4% (55/105), 67.5% (106/157), 74.6% (150/201), and 75.0% (171/228), respectively. The proportions achieving SALT score ≤5 were 0%, 16.7%, 26.0%, 31.4%, 51.6%, 55.2%, and 62.7% at W52, respectively among the SALT score ≤20 responders at each timepoint.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="auto">Among patients treated with baricitinib 2-mg, the proportions of SALT score ≤20 </span><span data-contrast="auto">responders who achieved </span><span data-contrast="auto">SALT score ≤10 at W4, 8, 12, 16, 24, 36, and 52 were 0% (0/2), 37.5% (3/8), 50.0% (7/14), 48.5% (16/33), 63.5% (33/52), 62.2% (51/82), and 71.0% (66/93), respectively. The proportions achieving SALT score ≤5 were 0%, 12.5%, 28.6%, 24.2%, 34.6%, 42.7%, and 47.3% at W52, respectively among the SALT score ≤20 responders at each timepoint. Patients achieving SALT score ≤10 or ≤5 tended to have less severe baseline disease characteristics relative to the overall population.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto">Conclusions: </span></strong><span data-contrast="auto">A significant proportion of patients who achieved SALT score ≤20 with baricitinib treatment also achieved complete or nearly complete scalp coverage, with some patients achieving this as early as Week 8. The proportion of complete or nearly complete responders increased over time with continued therapy. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Justin Ko, Amy McMichael, Maria Hordinsky, Thierry Passeron, Yutaka Shimomura, Samuel Ogwu, Rukhsar Chughtai, Najwa Somani, Brett Kinghttps://skin.dermsquared.com/skin/article/view/3164Evidence-Based Data on How Long to Treat to Achieve Treatment Response With Baricitinib in Severe Alopecia Areata2024-11-25T10:57:37+00:00Brett Kingjofskin@gmail.comMaryanne Sennajofskin@gmail.comManabu Ohyamajofskin@gmail.comRodney Sinclairjofskin@gmail.comNajwa Somanijofskin@gmail.comYves Dutroncjofskin@gmail.comNa Lujofskin@gmail.comYun-Fei Chenjofskin@gmail.comJakub P. Jedynakjofskin@gmail.comAndrew Buchananjofskin@gmail.comBianca M. Piraccinijofskin@gmail.com<p><strong><span data-contrast="auto">Introduction</span></strong><strong><span data-contrast="auto">: </span></strong><span data-contrast="auto">Previous data on baricitinib treatment in severe alopecia areata (AA) has shown that treatment response varies by baseline disease severity and by duration of current episode. In general, hair regrowth response varies, and clinicians lack data on how long to optimally treat patients to achieve response. </span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">In the literature, time to onset of improvement (defined as 30% improvement from baseline SALT score, i.e. SALT</span><span data-contrast="auto">30</span> <span data-contrast="auto">can predict ultimate achievement of SALT score ≤20 by Week 52. In this analysis, we evaluated improvement(SALT</span><span data-contrast="auto">30</span><span data-contrast="auto">) and meaningful response(SALT score ≤20), in clinically relevant subpopulations to characterize time required to treat patients based on their disease presentation. </span><span data-ccp-props="{}"> </span></p> <p><strong><span data-contrast="auto">Procedure:</span></strong> <span data-contrast="auto">Patients randomized to treatment with baricitinib 4mg daily for up to 52 weeks were evaluated from the pooled BRAVE AA1/AA2 phase 3 trials according to four clinically relevant subpopulations divided by baseline SALT score (severe: 50-94; very severe: 95-100) and current AA episode duration (<4 years; </span><span data-contrast="auto">></span><span data-contrast="auto">4 years). </span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">Patients achieving SALT</span><span data-contrast="auto">30</span><span data-contrast="auto"> improvement across visits was evaluated for each subpopulation. Among those achieving SALT</span><span data-contrast="auto">30</span><span data-contrast="auto">, proportion of patients achieving SALT score ≤20 through Week 52 was evaluated at the timepoint during which SALT</span><span data-contrast="auto">30</span><span data-contrast="auto"> improvers began to plateau. Non- Responder Imputation was used for the missing SALT</span><span data-contrast="auto">30</span><span data-contrast="auto"> and SALT score ≤20.</span><span data-ccp-props="{}"> </span></p> <p><strong><span data-contrast="auto">Results</span></strong><span data-contrast="auto">: Among subpopulations with baseline severe AA, the proportion of SALT</span><span data-contrast="auto">30</span><span data-contrast="auto"> improvers plateaued between 24weeks (61-70%) and 36 weeks (63%-73%) of treatment. Among those who reached SALT</span><span data-contrast="auto">30</span><span data-contrast="auto"> improvement at Week 24, achievement of SALT score ≤20 at Week 52 was 75% vs. 65%, respectively among those with < 4 years vs. </span><span data-contrast="auto">></span><span data-contrast="auto"> 4 years duration of current episode. </span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">In the baseline very severe AA group, the proportion of SALT</span><span data-contrast="auto">30</span><span data-contrast="auto"> improvers continued to increase through 52 weeks without plateau.</span><span data-ccp-props="{}"> </span></p> <p><strong><span data-contrast="auto">Discussion</span></strong><strong><span data-contrast="auto">: </span></strong><span data-contrast="auto">This data suggests that 'how long to treat’ with baricitinib 4 mg monotherapy can be tailored to patient baseline characteristics. Evidence of improvement (SALT</span><span data-contrast="auto">30</span><span data-contrast="auto">) is seen relatively early among those patients with baseline severe SALT score(50-94). Most who achieve improvement at 6 months achieve clinical response (SALT score </span><span data-contrast="auto"><</span><span data-contrast="auto"> 20) within a year of treatment. This suggests that if improvement is seen by 6 months, treatment should be continued to achieve optimal outcomes. </span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">Patients with a very severe SALT score (95-100) at baseline (i.e. alopecia totalis or universalis) show continuing (SALT</span><span data-contrast="auto">30</span><span data-contrast="auto">) improvement up to 1 year. Very severe AA may need at least 1 year to see evidence of treatment effect before considering a stop or switch in therapy, and longer treatment may be required in some improvers to achieve optimal outcomes.</span><span data-ccp-props="{}"> </span></p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Brett King, Maryanne Senna, Manabu Ohyama, Rodney Sinclair, Najwa Somani, Yves Dutronc, Na Lu, Yun-Fei Chen, Jakub P. Jedynak, Andrew Buchanan, Bianca M. Piraccinihttps://skin.dermsquared.com/skin/article/view/3165Characterizing Loss of Response Occurring in a Small Number of Patients During 3 Years of Long-Term Maintenance Therapy with Baricitinib 4-mg: Results From BRAVE-AA1 and -AA2 Trials2024-11-25T13:08:27+00:00Maryanne Sennajofskin@gmail.comSusan Taylorjofskin@gmail.comBianca M. Piraccinijofskin@gmail.comJerry Shapirojofskin@gmail.comNajwa Somanijofskin@gmail.comJakub P. Jedynakjofskin@gmail.comSamuel Ogwujofskin@gmail.comAndrew Buchananjofskin@gmail.comBrittany Craiglowjofskin@gmail.comManabu Ohyamajofskin@gmail.com<p><strong>Introduction:</strong> Baricitinib, a approved for adults with severe alopecia areata (AA), demonstrated a high level of sustained efficacy (89.1%) at Week 152 among patients who achieved a Severity of Alopecia Tool (SALT) score ≤20 at Week 52 following one year of treatment with once-daily baricitinib 4 mg in phase 3 trials (BRAVE-AA1, BRAVE-AA2). In this post hoc analysis, we characterize patterns of loss of response during maintenance treatment (Weeks 52–152) among the 10.9% (n=14) of patients who demonstrated loss of response (SALT score >20) at Week 152 and explore differences between patients who lost vs maintained response.</p> <p><strong>Methods:</strong> Patient records were reviewed to identify patients who demonstrated loss of response at Week 152. Descriptive statistics were used to summarize baseline characteristics and the timing and extent of loss for these patients.</p> <p><strong>Results:</strong> Baseline disease characteristics differed between those losing (10.9%, n=14/129) and those maintaining (89.1%, n=115/129) treatment response. Characteristics that were numerically more common among those losing vs maintaining response were a longer baseline duration of current episode (≥4 years; 50.0% vs 20.9%, respectively) and baseline very severe AA (SALT score 95–100; 64.3% vs 35.7%, respectively). Seven patients who lost response had received a COVID-19 vaccination and/or experienced a COVID-19 infection during the maintenance period; four of these patients had a vaccination or infection ≤6 months before their initial loss of response. Overall, time to loss of response varied: six lost response within the first 4 weeks of maintenance treatment (Weeks 52–56); eight lost response at or after Week 88. The magnitude of change in SALT score also varied: 35.7% (n=5) maintained a SALT score ≤30 throughout Weeks 52–152; 21.4% (n=3) worsened to a SALT score >90 at ≥1 maintenance period visit. The median SALT score at Week 152 among patients demonstrating loss of response was 32.5.</p> <p><strong>Conclusions:</strong> A small number of patients demonstrated loss of response at Week 152 during the maintenance phase of the BRAVE trials. A third of those who lost response maintained at least 70% scalp coverage throughout the two-year maintenance period, which followed one year of initial treatment. Future research is needed to confirm what factors potentially trigger loss of response on baricitinib monotherapy and to determine the potential role of adjunctive therapies in mitigating this risk.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Maryanne Senna, Susan Taylor, Bianca M. Piraccini, Jerry Shapiro, Najwa Somani, Jakub P. Jedynak, Samuel Ogwu, Andrew Buchanan, Brittany Craiglow, Manabu Ohyamahttps://skin.dermsquared.com/skin/article/view/3166Understanding the Experience of Healthcare Access and Health-Related Impacts among Individuals with Alopecia Areata 2024-11-25T15:01:02+00:00Candrice Heathdrcandrice@drcandriceheath.comLisa Andersonlisa@naaf.orgShamsha Damanishamsha.damani@gmail.comElizabeth Baccielizabeth.bacci@evidera.comAndrew Buchananbuchanan_andrew_s@lilly.comJulia Correlljulia.correll@evidera.comEvangeline Pierceevangeline.pierce@lilly.comMelissa Constantinemelissa.constantine@evidera.comBeth Mitchellmitchell_beth_d@lilly.comRaj Chovatiyaraj.chovatiya@gmail.com<p>n/a</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Candrice R. Heath, Lisa Anderson, Shamsha Damani, Elizabeth D. Bacci, Andrew Buchanan, Julia R. Correll, Evangeline J. Pierce, Melissa L. Constantine, Beth Mitchell, Raj Chovatiyahttps://skin.dermsquared.com/skin/article/view/3153Long-Term Efficacy and Safety of Lebrikizumab Is Maintained in Patients With Moderate-to-Severe Atopic Dermatitis: Results Up to 3 Years From ADjoin2024-11-19T16:08:16+00:00Emma Guttman-Yasskyjofskin@gmail.comAlan Irvinejofskin@gmail.comEric Simpsonjofskin@gmail.comMelinda Gooderhamjofskin@gmail.comStephan Weidingerjofskin@gmail.comLynda Spelmanjofskin@gmail.comJonathan Silverbergjofskin@gmail.comHeidi Cranejofskin@gmail.comHany Elmaraghyjofskin@gmail.comLouise DeLuca-Carterjofskin@gmail.comMaria Lucia Buziqui Piruzelijofskin@gmail.comChaoran Hujofskin@gmail.comEvangeline Piercejofskin@gmail.comHelena Agelljofskin@gmail.comDiamant Thaçijofskin@gmail.com<p><strong><span data-contrast="auto">Introduction: </span></strong><span data-contrast="auto">We report efficacy and safety of lebrikizumab (LEB) in long-term extension study ADjoin (NCT04392154) following up to 152 Weeks (W) of continuous LEB treatment with/without TCS.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto">Methods: </span></strong><span data-contrast="auto">Patients in ADvocate1&2 who achieved per-protocol response (EASI 75 or IGA 0/1 without rescue) following 16W of LEB treatment were re-randomized 2:2:1 to LEB250mg Q2W, LEB250mg Q4W, or placebo (LEB withdrawal). Patients who completed W52 of ADvocate1&2 could enroll in ADjoin. Patients who completed 16W of ADhere could enroll into ADjoin; per-protocol LEB responders were randomized 2:1 to LEB250mg Q2W or Q4W. Intermittent use of topicals was allowed in ADvocate1&2 W16–52, topicals and short-term systemics were allowed in ADjoin. Data</span> <span data-contrast="auto">are reported for W16 LEB responders originating from ADvocate1&2 (N=181) and ADhere (N=86) who received LEB250mg Q2W or Q4W in ADjoin. Efficacy outcomes were assessed based on all collected data (as observed analysis) up to W100 of ADjoin (total 152W and 116W of LEB treatment for patients from ADvocate1&2 and ADhere, respectively). Safety was reported from ADjoin enrollment up to the data cut-off April 24, 2024. </span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto">Results: </span></strong><span data-contrast="auto">In patients from ADvocate1&2, at W152 IGA 0/1 was maintained by 82.9% (34/41; Q2W) and 84.0% (42/50; Q4W) and EASI 75 was maintained by 90.5% (57/63; Q2W) and 94.1% (64/68; Q4W) of patients. In patients from ADhere, at W116 IGA 0/1 was maintained by 86.7% (26/30; Q2W) and 91.7% (11/12; Q4W) and EASI 75 was maintained by 94.9% (37/39; Q2W) and 90.9% (20/22; Q4W) of patients. EASI 90 was reported by 79.4% (50/63; Q2W) and 86.8% (59/68; Q4W) of ADvocate1&2 patients at W152 and 84.6% (33/39; Q2W) and 86.4% (19/22; Q4W) of ADhere patients at W116.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="auto">During 100Ws of ADjoin, most adverse events (AE) reported were mild (29.2%, 78/267) or moderate (33.3%, n=89) in severity. Serious AEs were reported by 4.1% (n=11) of patients. There was one death due to natural causes in the ADhere Q2W arm. AEs leading to treatment discontinuation were reported by 2.6% (n=7) of patients. </span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto">Conclusion: </span></strong><span data-contrast="auto">Efficacy outcomes were maintained long-term, up to 3 years of continuous LEB treatment, in both LEB250mg Q2W and Q4W arms. The safety profile of LEB in ADjoin was consistent with previous LEB studies in patients with moderate-to-severe AD.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Emma Guttman-Yassky, Alan Irvine, Eric Simpson, Melinda Gooderham, Stephan Weidinger, Lynda Spelman, Jonathan Silverberg, Heidi Crane, Hany Elmaraghy, Louise DeLuca-Carter, Maria Lucia Buziqui Piruzeli, Chaoran Hu, Evangeline Pierce, Helena Agell, Diamant Thaçihttps://skin.dermsquared.com/skin/article/view/3152Lebrikizumab Confirms a Consistent Safety Profile in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis: Data From 11 Trials With Over 3000 Patient-Years of Exposure2024-11-19T15:56:03+00:00Linda Stein Goldjofskin@gmail.comEric Simpsonjofskin@gmail.comDiamant Thaçijofskin@gmail.comAlan Irvinejofskin@gmail.comMarjolein de Bruin-Wellerjofskin@gmail.comGaia Gallojofskin@gmail.comMaria Lucia Buziqui Piruzelijofskin@gmail.comHany Elmaraghyjofskin@gmail.comJinglin Zhongjofskin@gmail.comSonia Montmayeurjofskin@gmail.comRuth Colljofskin@gmail.comMark G. Lebwohljofskin@gmail.com<p><strong><span data-contrast="auto">Introduction</span></strong><span data-contrast="auto">: We provide updated long-term safety data for lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis (AD). </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto">Methods</span></strong><span data-contrast="auto">: Integrated data from 11 phase 2/3 clinical trials were summarized in 2 datasets: 1) All-placebo-controlled Week 0-16 (All-PC; lebrikizumab 250 mg every 2 weeks [LEBQ2W] vs placebo); and 2) All-LEB (includes patients who received ≥1 dose of lebrikizumab any time during the 11 studies). All-PC includes phase 3 studies ADvocate 1 and 2, ADhere, ADhere-J, ADopt-VA, and ADvantage, and phase 2b KGAF; All-LEB includes phase 3 ADore and ADjoin and phase 2 Treble and KGAH, in addition to those in All-PC. Percentage and exposure-adjusted incidence rates (IR)/100 patient-years exposure are provided for All-PC and All-LEB, with study-size adjusted for All-PC. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto">Results</span></strong><span data-contrast="auto">: In All-PC, there were 719 patients (205.9 PYE) in the placebo group and 1251 (375.8 PYE) in the LEBQ2W group. All-LEB had 2415 patients (3167.8 PYE). In All-PC, the frequency of treatment-emergent adverse events (TEAEs) was similar between treatment groups; most were nonserious and mild/moderate in severity and did not lead to treatment discontinuation. Frequencies of SAEs were low in All-PC (placebo, 1.7%; LEBQ2W, 1.2%), and IR decreased with longer lebrikizumab exposure (IR LEBQ2W in All-PC, 3.9; IR All-LEB, 2.9). One death was reported in the placebo group in All-PC and 4 deaths in All-LEB (no deaths were considered related to the study drug by investigators). The most frequently reported TEAE (Preferred Terms) in All-PC was atopic dermatitis (12.8%) for placebo and conjunctivitis (7.1%) for LEBQ2W. In the placebo-controlled period, frequencies of the following AEs were: conjunctivitis cluster (placebo, 3.0%; LEBQ2W, 11.7%), injection site reactions (placebo, 1.6%; LEBQ2W, 2.9%); and herpes zoster (placebo, 0.1%; LEBQ2W, 0.4%). Skin infections were reported less frequently with lebrikizumab (placebo, 6.0%; LEBQ2W, 2.4%). </span><span data-contrast="auto">The IRs of the AEs of special interest decreased (conjunctivitis cluster, injection site reactions) or remained stable (herpes zoster) with increased exposure years to lebrikizumab.</span><span data-contrast="auto"> </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto">Conclusion</span></strong><span data-contrast="auto">: Results of this updated integrated safety analysis are consistent with previously reported data</span><span data-contrast="auto">1</span><span data-contrast="auto"> from the lebrikizumab clinical trial program. IRs of most TEAEs did not increase with longer duration of exposure to lebrikizumab in adolescents and adults with AD.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Linda Stein Gold, Eric Simpson, Diamant Thaçi, Alan Irvine, Marjolein de Bruin-Weller, Gaia Gallo, Maria Lucia Buziqui Piruzeli, Hany Elmaraghy, Jinglin Zhong, Sonia Montmayeur, Ruth Coll, Mark G. Lebwohlhttps://skin.dermsquared.com/skin/article/view/3151Lebrikizumab Improves Atopic Dermatitis and Quality of Life in Patients With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab: Results From the ADapt Trial2024-11-19T15:42:06+00:00Jonathan Silverbergjofskin@gmail.comLindsay Ackermanjofskin@gmail.comJerry Bageljofskin@gmail.comLinda Stein Goldjofskin@gmail.comAndrew Blauveltjofskin@gmail.comDavid Rosmarinjofskin@gmail.comRaj Chovatiyajofskin@gmail.comMatthew Zirwasjofskin@gmail.comGil Yosipovitchjofskin@gmail.comJill Waibeljofskin@gmail.comJenny E. Murasejofskin@gmail.comBen Lockshinjofskin@gmail.comJamie Weismanjofskin@gmail.comAmber Reck Atwaterjofskin@gmail.comJennifer Properjofskin@gmail.comMaria Silkjofskin@gmail.comEvangeline Piercejofskin@gmail.comMaria Lucia Buziqui Piruzelijofskin@gmail.comSonia Montmayeurjofskin@gmail.comChristopher Schusterjofskin@gmail.comJinglin Zhongjofskin@gmail.comMaria Jose Ruedajofskin@gmail.comSreekumar Pillaijofskin@gmail.comEric Simpsonjofskin@gmail.com<p><span class="TextRun SCXW29920979 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW29920979 BCX8">ADapt</span><span class="NormalTextRun SCXW29920979 BCX8"> (NCT05369403)</span><span class="NormalTextRun SCXW29920979 BCX8">,</span><span class="NormalTextRun SCXW29920979 BCX8"> an open-label, Phase 3b, 24-week study</span><span class="NormalTextRun SCXW29920979 BCX8">,</span><span class="NormalTextRun SCXW29920979 BCX8"> evaluat</span><span class="NormalTextRun SCXW29920979 BCX8">ed</span><span class="NormalTextRun SCXW29920979 BCX8"> the efficacy and safety of lebrikizumab (LEB) in patients with moderate-to-severe atopic dermatitis (AD) previously treated with dupilumab (DUPI). Patients </span><span class="NormalTextRun SCXW29920979 BCX8">must </span><span class="NormalTextRun SCXW29920979 BCX8">have discontinued DUPI due to inadequate response </span><span class="NormalTextRun SCXW29920979 BCX8">(non-response, partial response, or loss of response), intolerance or an adverse event (AE), or other reasons</span><span class="NormalTextRun SCXW29920979 BCX8">. </span><span class="NormalTextRun SCXW29920979 BCX8">Four</span> <span class="NormalTextRun SCXW29920979 BCX8">or more </span><span class="NormalTextRun SCXW29920979 BCX8">weeks after discontinuing</span><span class="NormalTextRun SCXW29920979 BCX8"> DUPI</span><span class="NormalTextRun SCXW29920979 BCX8">, p</span><span class="NormalTextRun SCXW29920979 BCX8">atients received a 500-mg LEB loading dose </span><span class="NormalTextRun SCXW29920979 BCX8">at Baseline and at Week 2 </span><span class="NormalTextRun SCXW29920979 BCX8">followed by 250 mg every 2 weeks through Week 16 (Q2W). At Week 16, </span><span class="NormalTextRun SCXW29920979 BCX8">responders (</span><span class="NormalTextRun SCXW29920979 BCX8">IGA 0 or 1 with ≥2-point improvement (IGA0,1) or EASI75 </span><span class="NormalTextRun SCXW29920979 BCX8">[</span><span class="NormalTextRun SCXW29920979 BCX8">primary endpoint</span><span class="NormalTextRun SCXW29920979 BCX8">]</span><span class="NormalTextRun SCXW29920979 BCX8">) receive</span><span class="NormalTextRun SCXW29920979 BCX8">d</span><span class="NormalTextRun SCXW29920979 BCX8"> LEB 250 mg once every 4 weeks (Q4W); other patients continued with </span><span class="NormalTextRun SCXW29920979 BCX8">250 mg</span> <span class="NormalTextRun SCXW29920979 BCX8">Q2W. Q2W and Q4W data were pooled and analyzed as-observed and </span><span class="NormalTextRun SCXW29920979 BCX8">with </span><span class="NormalTextRun SpellingErrorV2Themed SCXW29920979 BCX8">nonresponder</span><span class="NormalTextRun SCXW29920979 BCX8">/multiple imputation (NRI/MI).</span></span> <span class="TextRun SCXW29920979 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW29920979 BCX8">Among 86 enrolled patients,</span></span> <span class="TextRun SCXW29920979 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW29920979 BCX8">56% </span><span class="NormalTextRun SCXW29920979 BCX8">discontinued </span><span class="NormalTextRun SCXW29920979 BCX8">DUPI </span><span class="NormalTextRun SCXW29920979 BCX8">due to </span><span class="NormalTextRun SCXW29920979 BCX8">inadequate respon</span><span class="NormalTextRun SCXW29920979 BCX8">se</span><span class="NormalTextRun SCXW29920979 BCX8">, 16% </span><span class="NormalTextRun SCXW29920979 BCX8">due to</span><span class="NormalTextRun SCXW29920979 BCX8"> intolerance/AEs to DUPI, and 28% for other reasons. </span><span class="NormalTextRun SCXW29920979 BCX8">For all patients, </span><span class="NormalTextRun SCXW29920979 BCX8">a</span><span class="NormalTextRun SCXW29920979 BCX8">t Week</span><span class="NormalTextRun SCXW29920979 BCX8">s</span><span class="NormalTextRun SCXW29920979 BCX8"> 16</span><span class="NormalTextRun SCXW29920979 BCX8"> and </span><span class="NormalTextRun SCXW29920979 BCX8">24</span><span class="NormalTextRun SCXW29920979 BCX8">, respectively,</span><span class="NormalTextRun SCXW29920979 BCX8"> proportions of patients achieving:</span><span class="NormalTextRun SCXW29920979 BCX8"> 1) EASI75</span><span class="NormalTextRun SCXW29920979 BCX8">:</span><span class="NormalTextRun SCXW29920979 BCX8"> 57.4%</span><span class="NormalTextRun SCXW29920979 BCX8"> and </span><span class="NormalTextRun SCXW29920979 BCX8">60.0%</span><span class="NormalTextRun SCXW29920979 BCX8">,</span> <span class="NormalTextRun SCXW29920979 BCX8">as-</span><span class="NormalTextRun SCXW29920979 BCX8">observed; 50.7%</span><span class="NormalTextRun SCXW29920979 BCX8"> and </span><span class="NormalTextRun SCXW29920979 BCX8">52.8% NRI/MI; 2) IGA0,1</span><span class="NormalTextRun SCXW29920979 BCX8">:</span><span class="NormalTextRun SCXW29920979 BCX8"> 38.7%</span><span class="NormalTextRun SCXW29920979 BCX8"> and </span><span class="NormalTextRun SCXW29920979 BCX8">38.2%</span><span class="NormalTextRun SCXW29920979 BCX8">,</span> <span class="NormalTextRun SCXW29920979 BCX8">as-</span><span class="NormalTextRun SCXW29920979 BCX8">observed; 35.6%</span><span class="NormalTextRun SCXW29920979 BCX8"> and </span><span class="NormalTextRun SCXW29920979 BCX8">36.8%</span><span class="NormalTextRun SCXW29920979 BCX8">,</span><span class="NormalTextRun SCXW29920979 BCX8"> NRI/MI; </span><span class="NormalTextRun SCXW29920979 BCX8">3) Face-IGA 0: 42%</span><span class="NormalTextRun SCXW29920979 BCX8"> and </span><span class="NormalTextRun SCXW29920979 BCX8">49%, </span><span class="NormalTextRun SCXW29920979 BCX8">as-</span><span class="NormalTextRun SCXW29920979 BCX8">observed; 4</span><span class="NormalTextRun SCXW29920979 BCX8">) Pruritus NRS ≥4-point improvement 53.2%</span><span class="NormalTextRun SCXW29920979 BCX8"> and </span><span class="NormalTextRun SCXW29920979 BCX8">61.5% </span><span class="NormalTextRun SCXW29920979 BCX8">as-</span><span class="NormalTextRun SCXW29920979 BCX8">observed; 48.8%</span><span class="NormalTextRun SCXW29920979 BCX8"> and </span><span class="NormalTextRun SCXW29920979 BCX8">47.9% NRI/MI; and </span><span class="NormalTextRun SCXW29920979 BCX8">5</span><span class="NormalTextRun SCXW29920979 BCX8">) DLQI ≥4-point improvement 83.0%</span><span class="NormalTextRun SCXW29920979 BCX8"> and </span><span class="NormalTextRun SCXW29920979 BCX8">83.0% </span><span class="NormalTextRun SCXW29920979 BCX8">as-</span><span class="NormalTextRun SCXW29920979 BCX8">observed. The safety profile was consistent with other LEB Phase 3 trials. </span><span class="NormalTextRun SCXW29920979 BCX8">Four</span><span class="NormalTextRun SCXW29920979 BCX8"> patients who discontinued DUPI due to conjunctivitis did not </span><span class="NormalTextRun SCXW29920979 BCX8">report</span><span class="NormalTextRun SCXW29920979 BCX8"> conjunctivitis with LEB. </span><span class="NormalTextRun SCXW29920979 BCX8">3.5% of </span><span class="NormalTextRun SCXW29920979 BCX8">patients</span> <span class="NormalTextRun SCXW29920979 BCX8">reported </span><span class="NormalTextRun SCXW29920979 BCX8">treatment-emergent</span><span class="NormalTextRun SCXW29920979 BCX8"> conjunctivitis</span><span class="NormalTextRun SCXW29920979 BCX8">. </span></span> <span class="TextRun SCXW29920979 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW29920979 BCX8">In DUPI-experienced patients, treatment of moderate-to-severe AD with LEB resulted in meaningful improvements in skin clearance, itch, and quality of life.</span></span></p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Jonathan Silverberg, Lindsay Ackerman, Jerry Bagel, Linda Stein Gold, Andrew Blauvelt, David Rosmarin, Raj Chovatiya, Matthew Zirwas, Gil Yosipovitch, Jill Waibel, Jenny E. Murase, Ben Lockshin, Jamie Weisman, Amber Reck Atwater, Jennifer Proper, Maria Silk, Evangeline Pierce, Maria Lucia Buziqui Piruzeli, Sonia Montmayeur, Christopher Schuster, Jinglin Zhong, Maria Jose Rueda, Sreekumar Pillai, Eric Simpsonhttps://skin.dermsquared.com/skin/article/view/3156Treatment Preferences, Monthly Injection is the Preferred Frequency of Administration in the Treatment of Moderate to Severe Atopic Dermatitis: Results from a Real-World Survey in the United States 2024-11-19T22:37:36+00:00William Malatestinicwmalatestinic@indy.rr.comApril Armstrongaprilarmstrong@post.harvard.eduBob Genggeng.bob@gmail.comPeter Liopeterlio@gmail.comMelodie Youngmelodieyoung@aol.comTomas Chaotomasjchao@aol.comEvangeline Pierceevangeline.pierce@lilly.comZach Dawsonzach.dawson@lilly.com<p>None</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 William Malatestinic, April Armstrong, Bob Geng, Peter Lio, Melodie Young, Tomas Chao, Evangeline Pierce, Zach Dawsonhttps://skin.dermsquared.com/skin/article/view/3146Assessing Post-Inflammatory Pigmentation in Atopic Dermatitis: Reliability of the PDCA-Derm™2024-11-19T10:03:26+00:00Andrew Alexisdrandrewalexis@gmail.comEvangeline Pierceevangeline.pierce@lilly.comAndrea Coheecohee_andrea@lilly.comSylvia Susu_sylvia@lilly.comAmber Reck Atwaterdramberatwater@gmail.comMaria Jose Ruedarueda_maria_jose@lilly.comSonia Montmayeurmontmayeur_sonia@lilly.comBrittany Kloosterbrittany.klooster@adelphivalues.comCaitlyn Lowecaitlyn.lowe@adelphivalues.comJonathan Silverbergjonathanisilverberg@gmail.com<p><strong>Introduction:</strong> Atopic dermatitis (AD) is a chronic, relapsing, heterogeneous inflammatory disorder. After a flare-up, the affected skin may have areas of post-inflammatory hyper- or hypo-pigmentation (PIH). A new scale, the PDCA-Derm™, assesses PIH by comparing post-inflammatory lesions to adjacent normal skin. This single-item clinician-reported outcome measure addresses a key gap in AD skin assessment. The primary objective of this study was to evaluate qualitative and quantitative data obtained from healthcare providers (HCPs) on the suitability of the PDCA-Derm for use in patients with moderate-to-severe AD.</p> <p><strong>Methods</strong>: HCPs recruited were dermatologists who treat patients with moderate-to-severe AD. During individual 60-minute cognitive debriefing meetings, each HCP was asked about their interpretation of the instructions and response options of the PDCA-Derm, and their opinion on its suitability to capture changes in PIH in patients with moderate-to-severe AD of all skin tones. Using a series of photos (n=22), HCPs assessed PIH using the PDCA-Derm at 2 timepoints. The intraclass correlation coefficient (ICC) was used to evaluate intra- and inter-rater reliability.</p> <p><strong>Results</strong>: Ten HCPs, all holding a Doctor of Medicine as their highest degree, participated in the study. The mean age of participants was 51.4 years (standard deviation: 13.7), and over half (n=6) were female. Most HCPs reported having 11 or more years of experience practicing in dermatology (n=8). Six HCPs reported that 26–50% of both their patients overall and those with AD were patients with skin of color. PDCA-Derm instructions and response options were correctly interpreted by all HCPs, and all reported the response options were distinct from one another. Seven HCPs indicated the PDCA-Derm was easy to use. Six HCPs indicated the PDCA-Derm could capture PIH, and 5 indicated it had the ability to capture changes to PIH in patients with moderate-to-severe AD. Intra-rater reliability was good to excellent (ICC=0.76–0.99, n=8) for all but 2 HCPs (ICC=0.55 and 0.74). The inter-rater reliability for PIH ranged from good at timepoint 1 (ICC=0.75, n=10) to excellent at timepoint 2 (ICC=0.90, n=10).</p> <p><strong>Conclusion</strong>: The PDCA-Derm was well understood by HCPs and had good inter- and intra-rater reliability, supporting its appropriateness for use to assess PIH in moderate-to-severe AD. Additional studies investigating HCP assessment of the PDCA-Derm and its reliability are needed to make solid conclusions about the instrument's validity.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Andrew Alexis, Evangeline Pierce, Andrea Cohee, Sylvia Su, Amber Reck Atwater, Maria Jose Rueda, Sonia Montmayeur, Brittany Klooster, Caitlyn Lowe, Jonathan Silverberghttps://skin.dermsquared.com/skin/article/view/3149Lebrikizumab Improves Atopic Dermatitis in Adult and Adolescent Patients With Skin of Color: 16-Week Results From the ADmirable Study2024-11-19T15:25:34+00:00Andrew Alexisjofskin@gmail.comAli Moiinjofskin@gmail.comJill Waibeljofskin@gmail.comPaul Wallacejofskin@gmail.comDavid Cohenjofskin@gmail.comVivian Laquerjofskin@gmail.comPearl Kwongjofskin@gmail.comAmber Reck Atwaterjofskin@gmail.comJennifer Properjofskin@gmail.comMaria Silkjofskin@gmail.comEvangeline Piercejofskin@gmail.comSreekumar Pillaijofskin@gmail.comMaria Jose Ruedajofskin@gmail.comAngela Moorejofskin@gmail.com<p><span class="TextRun SCXW82839379 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><strong><span class="NormalTextRun SCXW82839379 BCX8">Introduction</span></strong><span class="NormalTextRun SCXW82839379 BCX8"><strong>:</strong> </span></span><span class="TextRun SCXW82839379 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW82839379 BCX8">Lebrikizumab is a novel monoclonal antibody that binds with high affinity and </span><span class="NormalTextRun SCXW82839379 BCX8">a </span><span class="NormalTextRun SCXW82839379 BCX8">slow off-rate to interleukin (IL)-13, thereby blocking the downstream effects of IL</span><span class="NormalTextRun SCXW82839379 BCX8">13 with high potency.</span> <span class="NormalTextRun SpellingErrorV2Themed SCXW82839379 BCX8">ADmirable</span><span class="NormalTextRun SCXW82839379 BCX8"> (NCT05372419)</span><span class="NormalTextRun SCXW82839379 BCX8"> is an ongoing, open-label, Phase 3b</span><span class="NormalTextRun SCXW82839379 BCX8"> clinical trial</span> <span class="NormalTextRun SCXW82839379 BCX8">of </span><span class="NormalTextRun SCXW82839379 BCX8">lebrikizumab in patients with moderate-to-severe </span><span class="NormalTextRun SCXW82839379 BCX8">atopic dermatitis (</span><span class="NormalTextRun SCXW82839379 BCX8">AD</span><span class="NormalTextRun SCXW82839379 BCX8">)</span><span class="NormalTextRun SCXW82839379 BCX8"> and skin of color </span><span class="NormalTextRun SCXW82839379 BCX8">(SoC)</span><span class="NormalTextRun SCXW82839379 BCX8">.</span> <span class="NormalTextRun SCXW82839379 BCX8">These are the first </span><span class="NormalTextRun SCXW82839379 BCX8">primary </span><span class="NormalTextRun SCXW82839379 BCX8">results of any Phase 3 clinical trial </span><span class="NormalTextRun SCXW82839379 BCX8">studying</span><span class="NormalTextRun SCXW82839379 BCX8"> patients with AD and SoC, a historically underrepresented patient population.</span> </span></p> <p><strong><span class="TextRun SCXW82839379 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW82839379 BCX8">Methods: </span></span></strong><span class="TextRun SCXW82839379 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW82839379 BCX8">At baseline and </span><span class="NormalTextRun SCXW82839379 BCX8">W</span><span class="NormalTextRun SCXW82839379 BCX8">eek 2, patients received 500</span><span class="NormalTextRun SCXW82839379 BCX8">-</span><span class="NormalTextRun SCXW82839379 BCX8">mg lebrikizumab loading dose</span><span class="NormalTextRun SCXW82839379 BCX8">s</span><span class="NormalTextRun SCXW82839379 BCX8"> followed by 250</span><span class="NormalTextRun SCXW82839379 BCX8">-</span><span class="NormalTextRun SCXW82839379 BCX8">mg every 2 weeks through </span><span class="NormalTextRun SCXW82839379 BCX8">W</span><span class="NormalTextRun SCXW82839379 BCX8">eek 16.</span> <span class="NormalTextRun SCXW82839379 BCX8">Concomitant t</span><span class="NormalTextRun SCXW82839379 BCX8">opical </span><span class="NormalTextRun SCXW82839379 BCX8">therapy</span><span class="NormalTextRun SCXW82839379 BCX8"> was allowed.</span> <span class="NormalTextRun SCXW82839379 BCX8">Pa</span><span class="NormalTextRun SCXW82839379 BCX8">tients</span> <span class="NormalTextRun SCXW82839379 BCX8">receiving</span> <span class="NormalTextRun SCXW82839379 BCX8">protocol-</span><span class="NormalTextRun SCXW82839379 BCX8">defined </span><span class="NormalTextRun SCXW82839379 BCX8">rescue therapy were </span><span class="NormalTextRun SCXW82839379 BCX8">discontinued</span><span class="NormalTextRun SCXW82839379 BCX8">.</span> <span class="NormalTextRun SCXW82839379 BCX8">Key eligibility criteria included: ≥12 years of age</span><span class="NormalTextRun SCXW82839379 BCX8">, </span><span class="NormalTextRun SCXW82839379 BCX8">self-reported race other than White, Fitzpatrick </span><span class="NormalTextRun SCXW82839379 BCX8">P</span><span class="NormalTextRun SCXW82839379 BCX8">hototype IV-VI, </span><span class="NormalTextRun SCXW82839379 BCX8">and </span><span class="NormalTextRun SCXW82839379 BCX8">moderate-to-severe AD</span><span class="NormalTextRun SCXW82839379 BCX8">.</span> <span class="NormalTextRun SCXW82839379 BCX8">This study includes</span></span> <span class="TextRun SCXW82839379 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW82839379 BCX8">new</span> <span class="NormalTextRun SCXW82839379 BCX8">objective</span><span class="NormalTextRun SCXW82839379 BCX8"> measures of pigment such as PDCA-Derm™.</span> <span class="NormalTextRun SCXW82839379 BCX8">E</span><span class="NormalTextRun SCXW82839379 BCX8">ndpoints</span><span class="NormalTextRun SCXW82839379 BCX8"> are summarized as </span><span class="NormalTextRun SCXW82839379 BCX8">observed</span><span class="NormalTextRun SCXW82839379 BCX8"> (primary</span><span class="NormalTextRun SCXW82839379 BCX8"> analysis)</span><span class="NormalTextRun SCXW82839379 BCX8"> and </span><span class="NormalTextRun SCXW82839379 BCX8">using</span> <span class="NormalTextRun SCXW82839379 BCX8">non-responder imputation</span><span class="NormalTextRun SCXW82839379 BCX8">/</span><span class="NormalTextRun SCXW82839379 BCX8">multiple imputation</span><span class="NormalTextRun SCXW82839379 BCX8"> (</span><span class="NormalTextRun SCXW82839379 BCX8">NRI/</span><span class="NormalTextRun SCXW82839379 BCX8">MI</span><span class="NormalTextRun SCXW82839379 BCX8">;</span><span class="NormalTextRun SCXW82839379 BCX8"> supporting analysis</span><span class="NormalTextRun SCXW82839379 BCX8">)</span><span class="NormalTextRun SCXW82839379 BCX8">.</span> </span></p> <p><span class="TextRun SCXW82839379 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><strong><span class="NormalTextRun SCXW82839379 BCX8">Results</span></strong><span class="NormalTextRun SCXW82839379 BCX8"><strong>:</strong> </span></span><span class="TextRun SCXW82839379 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW82839379 BCX8">At baseline</span><span class="NormalTextRun SCXW82839379 BCX8"> (N=</span><span class="NormalTextRun SCXW82839379 BCX8">90)</span><span class="NormalTextRun SCXW82839379 BCX8">, </span><span class="NormalTextRun SCXW82839379 BCX8">patients </span><span class="NormalTextRun SCXW82839379 BCX8">had</span><span class="NormalTextRun SCXW82839379 BCX8"> a </span><span class="NormalTextRun SCXW82839379 BCX8">mean (SD)</span><span class="NormalTextRun SCXW82839379 BCX8"> age </span><span class="NormalTextRun SCXW82839379 BCX8">of</span> <span class="NormalTextRun SCXW82839379 BCX8">40.7</span><span class="NormalTextRun SCXW82839379 BCX8"> (</span><span class="NormalTextRun SCXW82839379 BCX8">19.6</span><span class="NormalTextRun SCXW82839379 BCX8">) years</span><span class="NormalTextRun SCXW82839379 BCX8">,</span><span class="NormalTextRun SCXW82839379 BCX8"> AD d</span><span class="NormalTextRun SCXW82839379 BCX8">isease duration </span><span class="NormalTextRun SCXW82839379 BCX8">of</span> <span class="NormalTextRun SCXW82839379 BCX8">19.7</span><span class="NormalTextRun SCXW82839379 BCX8"> (</span><span class="NormalTextRun SCXW82839379 BCX8">16.1</span><span class="NormalTextRun SCXW82839379 BCX8">) years</span><span class="NormalTextRun SCXW82839379 BCX8">, </span><span class="NormalTextRun SCXW82839379 BCX8">Eczema </span><span class="NormalTextRun SCXW82839379 BCX8">Area</span><span class="NormalTextRun SCXW82839379 BCX8"> and Severity Index </span><span class="NormalTextRun SCXW82839379 BCX8">(</span><span class="NormalTextRun SCXW82839379 BCX8">EASI</span><span class="NormalTextRun SCXW82839379 BCX8">)</span><span class="NormalTextRun SCXW82839379 BCX8"> of </span><span class="NormalTextRun SCXW82839379 BCX8">26.4</span><span class="NormalTextRun SCXW82839379 BCX8"> (</span><span class="NormalTextRun SCXW82839379 BCX8">12.2</span><span class="NormalTextRun SCXW82839379 BCX8">)</span><span class="NormalTextRun SCXW82839379 BCX8">,</span> <span class="NormalTextRun SCXW82839379 BCX8">and </span><span class="NormalTextRun SCXW82839379 BCX8">Pruritus Numeric Rating Scale (NRS)</span><span class="NormalTextRun SCXW82839379 BCX8"> of 7.0 (2.2)</span><span class="NormalTextRun SCXW82839379 BCX8">.</span> <span class="NormalTextRun SCXW82839379 BCX8">Forty-three percent of p</span><span class="NormalTextRun SCXW82839379 BCX8">atients were </span><span class="NormalTextRun SCXW82839379 BCX8">female and </span><span class="NormalTextRun SCXW82839379 BCX8">1</span><span class="NormalTextRun SCXW82839379 BCX8">6</span><span class="NormalTextRun SCXW82839379 BCX8">% </span><span class="NormalTextRun SCXW82839379 BCX8">were </span><span class="NormalTextRun SCXW82839379 BCX8">adolescent.</span> <span class="NormalTextRun SCXW82839379 BCX8">Most</span><span class="NormalTextRun SCXW82839379 BCX8"> patients had </span><span class="NormalTextRun SCXW82839379 BCX8">an Investigator’s Global Assessment (</span><span class="NormalTextRun SCXW82839379 BCX8">IGA</span><span class="NormalTextRun SCXW82839379 BCX8">)</span> <span class="NormalTextRun SCXW82839379 BCX8">of </span><span class="NormalTextRun SCXW82839379 BCX8">3</span><span class="NormalTextRun SCXW82839379 BCX8"> (69%)</span><span class="NormalTextRun SCXW82839379 BCX8">. </span><span class="NormalTextRun SCXW82839379 BCX8">P</span><span class="NormalTextRun SCXW82839379 BCX8">atients self-reported </span><span class="NormalTextRun SCXW82839379 BCX8">their race </span><span class="NormalTextRun SCXW82839379 BCX8">as </span><span class="NormalTextRun SCXW82839379 BCX8">Black/African American (</span><span class="NormalTextRun SCXW82839379 BCX8">78</span><span class="NormalTextRun SCXW82839379 BCX8">%), Asian (</span><span class="NormalTextRun SCXW82839379 BCX8">11</span><span class="NormalTextRun SCXW82839379 BCX8">%), American Indian/Alaskan Native (</span><span class="NormalTextRun SCXW82839379 BCX8">7</span><span class="NormalTextRun SCXW82839379 BCX8">%)</span><span class="NormalTextRun SCXW82839379 BCX8">,</span><span class="NormalTextRun SCXW82839379 BCX8"> and Native Hawaiian or Other Pacific Islander (4%)</span><span class="NormalTextRun SCXW82839379 BCX8">.</span> <span class="NormalTextRun SCXW82839379 BCX8">Patients </span><span class="NormalTextRun SCXW82839379 BCX8">had</span><span class="NormalTextRun SCXW82839379 BCX8"> Fitzpatrick Phototypes of IV (</span><span class="NormalTextRun SCXW82839379 BCX8">43</span><span class="NormalTextRun SCXW82839379 BCX8">%), V (</span><span class="NormalTextRun SCXW82839379 BCX8">24</span><span class="NormalTextRun SCXW82839379 BCX8">%), and VI (</span><span class="NormalTextRun SCXW82839379 BCX8">32</span><span class="NormalTextRun SCXW82839379 BCX8">%).</span> <span class="NormalTextRun SCXW82839379 BCX8">At</span><span class="NormalTextRun SCXW82839379 BCX8"> Week 16, </span><span class="NormalTextRun SCXW82839379 BCX8">69.2</span><span class="NormalTextRun SCXW82839379 BCX8">% </span><span class="NormalTextRun SCXW82839379 BCX8">(54/78) </span><span class="NormalTextRun SCXW82839379 BCX8">of patients achieved </span><span class="NormalTextRun SCXW82839379 BCX8">a </span><span class="NormalTextRun SCXW82839379 BCX8">75% improvement in EASI</span><span class="NormalTextRun SCXW82839379 BCX8"> (NRI</span><span class="NormalTextRun SCXW82839379 BCX8">/MI</span><span class="NormalTextRun SCXW82839379 BCX8">,</span><span class="NormalTextRun SCXW82839379 BCX8"> 66.9%</span><span class="NormalTextRun SCXW82839379 BCX8">)</span><span class="NormalTextRun SCXW82839379 BCX8">, </span><span class="NormalTextRun SCXW82839379 BCX8">44.9</span><span class="NormalTextRun SCXW82839379 BCX8">% </span><span class="NormalTextRun SCXW82839379 BCX8">(35/78) </span><span class="NormalTextRun SCXW82839379 BCX8">achieved </span><span class="NormalTextRun SCXW82839379 BCX8">a 90% improvement in </span><span class="NormalTextRun SCXW82839379 BCX8">EASI</span><span class="NormalTextRun SCXW82839379 BCX8"> (NRI/MI</span><span class="NormalTextRun SCXW82839379 BCX8">,</span><span class="NormalTextRun SCXW82839379 BCX8"> 42.5%</span><span class="NormalTextRun SCXW82839379 BCX8">)</span><span class="NormalTextRun SCXW82839379 BCX8">, </span><span class="NormalTextRun SCXW82839379 BCX8">44.9</span><span class="NormalTextRun SCXW82839379 BCX8">%</span><span class="NormalTextRun SCXW82839379 BCX8"> (35</span><span class="NormalTextRun SCXW82839379 BCX8">/78)</span><span class="NormalTextRun SCXW82839379 BCX8"> achieved an </span><span class="NormalTextRun SCXW82839379 BCX8">IGA 0</span><span class="NormalTextRun SCXW82839379 BCX8">/</span><span class="NormalTextRun SCXW82839379 BCX8">1</span><span class="NormalTextRun SCXW82839379 BCX8"> with ≥2-point </span><span class="NormalTextRun SCXW82839379 BCX8">improvement</span><span class="NormalTextRun SCXW82839379 BCX8"> (</span><span class="NormalTextRun SCXW82839379 BCX8">NRI/MI</span><span class="NormalTextRun SCXW82839379 BCX8">,</span><span class="NormalTextRun SCXW82839379 BCX8"> 44.1%)</span><span class="NormalTextRun SCXW82839379 BCX8">, </span><span class="NormalTextRun SCXW82839379 BCX8">and 58.1</span><span class="NormalTextRun SCXW82839379 BCX8">% (</span><span class="NormalTextRun SCXW82839379 BCX8">36/62</span><span class="NormalTextRun SCXW82839379 BCX8">) </span><span class="NormalTextRun SCXW82839379 BCX8">reported</span> <span class="NormalTextRun SCXW82839379 BCX8">≥4-point </span><span class="NormalTextRun SCXW82839379 BCX8">Pruritus </span><span class="NormalTextRun SCXW82839379 BCX8">NRS </span><span class="NormalTextRun SCXW82839379 BCX8">improvement</span><span class="NormalTextRun SCXW82839379 BCX8"> (NRI/MI, </span><span class="NormalTextRun SCXW82839379 BCX8">55.4%)</span><span class="NormalTextRun SCXW82839379 BCX8">. </span><span class="NormalTextRun SCXW82839379 BCX8">Approximately 50% of patients </span><span class="NormalTextRun SCXW82839379 BCX8">reported </span><span class="NormalTextRun SCXW82839379 BCX8">itch improvement </span><span class="NormalTextRun SCXW82839379 BCX8">within </span><span class="NormalTextRun SCXW82839379 BCX8">6 weeks</span><span class="NormalTextRun SCXW82839379 BCX8">.</span> <span class="NormalTextRun SCXW82839379 BCX8">Using</span><span class="NormalTextRun SCXW82839379 BCX8"> PDCA-Derm</span><span class="NormalTextRun SCXW82839379 BCX8">™</span><span class="NormalTextRun SCXW82839379 BCX8">, </span><span class="NormalTextRun SCXW82839379 BCX8">hypopigmentation</span> <span class="NormalTextRun SCXW82839379 BCX8">and hyperpigmentation </span><span class="NormalTextRun SCXW82839379 BCX8">improved in </span><span class="NormalTextRun SCXW82839379 BCX8">33</span><span class="NormalTextRun SCXW82839379 BCX8">.3</span><span class="NormalTextRun SCXW82839379 BCX8">%</span> <span class="NormalTextRun SCXW82839379 BCX8">(</span><span class="NormalTextRun SCXW82839379 BCX8">4/12</span><span class="NormalTextRun SCXW82839379 BCX8">)</span><span class="NormalTextRun SCXW82839379 BCX8"> and </span><span class="NormalTextRun SCXW82839379 BCX8">63.0% </span><span class="NormalTextRun SCXW82839379 BCX8">(</span><span class="NormalTextRun SCXW82839379 BCX8">29/46)</span><span class="NormalTextRun SCXW82839379 BCX8"> of patients, respectively</span><span class="NormalTextRun SCXW82839379 BCX8"> (as </span><span class="NormalTextRun SCXW82839379 BCX8">observed</span><span class="NormalTextRun SCXW82839379 BCX8">)</span><span class="NormalTextRun SCXW82839379 BCX8">.</span> <span class="NormalTextRun SCXW82839379 BCX8">Most</span><span class="NormalTextRun SCXW82839379 BCX8"> treatment emergent adverse events </span><span class="NormalTextRun SCXW82839379 BCX8">(TEAE) </span><span class="NormalTextRun SCXW82839379 BCX8">were mild</span><span class="NormalTextRun SCXW82839379 BCX8">-</span><span class="NormalTextRun SCXW82839379 BCX8">to</span><span class="NormalTextRun SCXW82839379 BCX8">-</span><span class="NormalTextRun SCXW82839379 BCX8">moderate in severit</span><span class="NormalTextRun SCXW82839379 BCX8">y. N</span><span class="NormalTextRun SCXW82839379 BCX8">o TEAEs lead to discontinuation</span><span class="NormalTextRun SCXW82839379 BCX8"> and no </span><span class="NormalTextRun SCXW82839379 BCX8">cases of </span><span class="NormalTextRun SCXW82839379 BCX8">treatment-related </span><span class="NormalTextRun SCXW82839379 BCX8">conjunctivitis were reported</span><span class="NormalTextRun SCXW82839379 BCX8">.</span> <span class="NormalTextRun SCXW82839379 BCX8">N</span><span class="NormalTextRun SCXW82839379 BCX8">o </span><span class="NormalTextRun SCXW82839379 BCX8">serious adverse events</span><span class="NormalTextRun SCXW82839379 BCX8"> were </span><span class="NormalTextRun SCXW82839379 BCX8">observed</span><span class="NormalTextRun SCXW82839379 BCX8">.</span></span></p> <p><span class="TextRun SCXW82839379 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><strong><span class="NormalTextRun SCXW82839379 BCX8">Conclusion</span></strong><span class="NormalTextRun SCXW82839379 BCX8"><strong>:</strong> </span></span><span class="TextRun SCXW82839379 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW82839379 BCX8">Lebrikizumab improved </span><span class="NormalTextRun SCXW82839379 BCX8">signs </span><span class="NormalTextRun SCXW82839379 BCX8">and symptoms </span><span class="NormalTextRun SCXW82839379 BCX8">of </span><span class="NormalTextRun SCXW82839379 BCX8">disease</span><span class="NormalTextRun SCXW82839379 BCX8">, including </span><span class="NormalTextRun SCXW82839379 BCX8">post-inflammatory pigment </span><span class="NormalTextRun SCXW82839379 BCX8">discoloration</span><span class="NormalTextRun SCXW82839379 BCX8">, in patients with AD and SoC</span><span class="NormalTextRun SCXW82839379 BCX8"> and </span><span class="NormalTextRun SCXW82839379 BCX8">demonstrated</span><span class="NormalTextRun SCXW82839379 BCX8"> a favorable safety profile</span><span class="NormalTextRun SCXW82839379 BCX8">.</span><span class="NormalTextRun SCXW82839379 BCX8"> </span></span><span class="EOP SCXW82839379 BCX8" data-ccp-props="{"134233279":true,"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Andrew Alexis, Ali Moiin, Jill Waibel, Paul Wallace, David Cohen, Vivian Laquer, Pearl Kwong, Amber Reck Atwater, Jennifer Proper, Maria Silk, Evangeline Pierce, Sreekumar Pillai, Maria Jose Rueda, Angela Moorehttps://skin.dermsquared.com/skin/article/view/3147Achieving Depth of Response in Skin Clearance and Itch Relief With Lebrikizumab is Associated With Minimal Impact of Atopic Dermatitis on Quality of Life2024-11-19T14:57:59+00:00Raj Chovatiyajofskin@gmail.comEric Simpsonjofskin@gmail.comTilo Biedermannjofskin@gmail.comLeon Kircikjofskin@gmail.comVivian Y. Shijofskin@gmail.comIgnasi Figueras-Nartjofskin@gmail.comMarta Casillasjofskin@gmail.comGaia Gallojofskin@gmail.comYuxin Dingjofskin@gmail.comHong Zhangjofskin@gmail.comEvangeline Piercejofskin@gmail.comHelena Agelljofskin@gmail.comChristian Vestergaardjofskin@gmail.com<p><span class="TextRun SCXW18618141 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW18618141 BCX8">In Phase 3, monotherapy trials, ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967), </span><span class="NormalTextRun SCXW18618141 BCX8">Week</span> <span class="NormalTextRun SCXW18618141 BCX8">16-responders</span> <span class="NormalTextRun SCXW18618141 BCX8">treated with lebrikizumab (LEB) every 2 weeks (Q2W</span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW18618141 BCX8">)</span><span class="NormalTextRun SCXW18618141 BCX8"> and every 4 weeks (Q4W) </span><span class="NormalTextRun SCXW18618141 BCX8">demonstrated</span><span class="NormalTextRun SCXW18618141 BCX8"> extended maintenance of deep response</span><span class="NormalTextRun SCXW18618141 BCX8"> in skin clearance </span><span class="NormalTextRun SCXW18618141 BCX8">and</span><span class="NormalTextRun SCXW18618141 BCX8"> itch improvement. </span><span class="NormalTextRun SCXW18618141 BCX8">In this </span></span><span class="TextRun SCXW18618141 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW18618141 BCX8">post hoc</span></span><span class="TextRun SCXW18618141 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW18618141 BCX8"> analysis of ADvocate1</span><span class="NormalTextRun SCXW18618141 BCX8">/</span><span class="NormalTextRun SCXW18618141 BCX8">-</span><span class="NormalTextRun SCXW18618141 BCX8">2, among LEB responders (defined by achieving Investigator’s Global Assessment [IGA] 0 or 1 with ≥2-point improvement or ≥75% improvement in the Eczema Area and Severity Index </span><span class="NormalTextRun SCXW18618141 BCX8">[</span><span class="NormalTextRun SCXW18618141 BCX8">EASI75</span><span class="NormalTextRun SCXW18618141 BCX8">]</span><span class="NormalTextRun SCXW18618141 BCX8">, and not receiv</span><span class="NormalTextRun SCXW18618141 BCX8">ing</span><span class="NormalTextRun SCXW18618141 BCX8"> rescue medication</span><span class="NormalTextRun SCXW18618141 BCX8">,</span><span class="NormalTextRun SCXW18618141 BCX8"> including topical</span><span class="NormalTextRun SCXW18618141 BCX8">s,</span><span class="NormalTextRun SCXW18618141 BCX8"> at Week 16)</span><span class="NormalTextRun SCXW18618141 BCX8">, </span><span class="NormalTextRun SCXW18618141 BCX8">we evaluated quality of life (QOL) improvements for patients who achieved </span><span class="NormalTextRun SCXW18618141 BCX8">a </span><span class="NormalTextRun SCXW18618141 BCX8">deep response</span> <span class="NormalTextRun SCXW18618141 BCX8">to LEB</span> <span class="NormalTextRun SCXW18618141 BCX8">at Week 52</span><span class="NormalTextRun SCXW18618141 BCX8">, </span><span class="NormalTextRun SCXW18618141 BCX8">defined as: IGA score 0 (clear skin); ≥90% or 100% reduction in EASI (EASI90; EASI100)</span><span class="NormalTextRun SCXW18618141 BCX8">;</span><span class="NormalTextRun SCXW18618141 BCX8"> or Pruritus Numeric Rating Scale </span><span class="NormalTextRun SCXW18618141 BCX8">(PNRS; 0-10, none to worst itch imaginable)</span> <span class="NormalTextRun SCXW18618141 BCX8">scores 0 or 1 (PNRS01)</span><span class="NormalTextRun SCXW18618141 BCX8"> at Week 52</span><span class="NormalTextRun SCXW18618141 BCX8">.</span></span> <span class="TextRun SCXW18618141 BCX8" lang="EN-US" xml:lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW18618141 BCX8">QOL was assessed by the Dermatology Life Quality Index (DLQI), scored 0–30, with higher scores </span><span class="NormalTextRun SCXW18618141 BCX8">indicating</span><span class="NormalTextRun SCXW18618141 BCX8"> a worse effect of AD on QOL (scores ≤5: no/minimal effect; scores ≥11: </span><span class="NormalTextRun SCXW18618141 BCX8">very large</span><span class="NormalTextRun SCXW18618141 BCX8">/extremely</span><span class="NormalTextRun SCXW18618141 BCX8">-</span><span class="NormalTextRun SCXW18618141 BCX8">large effect). Descriptive analyses using as-observed data were reported at baseline</span><span class="NormalTextRun SCXW18618141 BCX8"> (Week 0)</span><span class="NormalTextRun SCXW18618141 BCX8"> and Week 52 for deep responders regardless of treatment arm (pooled) and by treatment arms separately. For patients with IGA0</span><span class="NormalTextRun SCXW18618141 BCX8"> at Week 52</span><span class="NormalTextRun SCXW18618141 BCX8">, mean (SD) DLQI scores decreased from 14.0 (7.5) at baseline to 1.8 (2.7) at Week 52 in the pooled dataset</span><span class="NormalTextRun SCXW18618141 BCX8"> (</span><span class="NormalTextRun SCXW18618141 BCX8">Nx</span><span class="NormalTextRun SCXW18618141 BCX8">=73)</span><span class="NormalTextRun SCXW18618141 BCX8"> and from 12.6 (7.9) to 1.6 (2.8) for LEBQ4W</span><span class="NormalTextRun SCXW18618141 BCX8"> (</span><span class="NormalTextRun SCXW18618141 BCX8">Nx</span><span class="NormalTextRun SCXW18618141 BCX8">=32)</span><span class="NormalTextRun SCXW18618141 BCX8">. For </span><span class="NormalTextRun SCXW18618141 BCX8">patients with </span><span class="NormalTextRun SCXW18618141 BCX8">EASI90</span><span class="NormalTextRun SCXW18618141 BCX8"> at Week 52</span><span class="NormalTextRun SCXW18618141 BCX8">, the scores decreased from 14.6 (7.3) to 2.6 (3.3) in the pooled dataset</span><span class="NormalTextRun SCXW18618141 BCX8"> (</span><span class="NormalTextRun SCXW18618141 BCX8">Nx</span><span class="NormalTextRun SCXW18618141 BCX8">=151)</span><span class="NormalTextRun SCXW18618141 BCX8"> and from 14.4 (7.5) to 2.4 (3.3) for LEBQ4W</span> <span class="NormalTextRun SCXW18618141 BCX8">(</span><span class="NormalTextRun SCXW18618141 BCX8">Nx</span><span class="NormalTextRun SCXW18618141 BCX8">=67)</span><span class="NormalTextRun SCXW18618141 BCX8">. For </span><span class="NormalTextRun SCXW18618141 BCX8">patient</span><span class="NormalTextRun SCXW18618141 BCX8">s</span><span class="NormalTextRun SCXW18618141 BCX8"> with </span><span class="NormalTextRun SCXW18618141 BCX8">EASI100</span><span class="NormalTextRun SCXW18618141 BCX8"> at Week 52</span><span class="NormalTextRun SCXW18618141 BCX8">, the scores decreased from 13.9 (7.4) to 1.9 (2.8) in the pooled dataset</span><span class="NormalTextRun SCXW18618141 BCX8"> (</span><span class="NormalTextRun SCXW18618141 BCX8">Nx</span><span class="NormalTextRun SCXW18618141 BCX8">=68)</span><span class="NormalTextRun SCXW18618141 BCX8"> and from 12.8 (8.2) to 1.6 (2.9) with LEBQ4W</span><span class="NormalTextRun SCXW18618141 BCX8"> (</span><span class="NormalTextRun SCXW18618141 BCX8">Nx</span><span class="NormalTextRun SCXW18618141 BCX8">=29)</span><span class="NormalTextRun SCXW18618141 BCX8">. For PNRS01, the scores decreased from 14.1 (6.8) to 1.4 (1.9) in the pooled dataset</span><span class="NormalTextRun SCXW18618141 BCX8"> (</span><span class="NormalTextRun SCXW18618141 BCX8">Nx</span><span class="NormalTextRun SCXW18618141 BCX8">=80)</span><span class="NormalTextRun SCXW18618141 BCX8"> and from 14.1 (7.5) to 1.3 (2.3) with LEBQ4W</span> <span class="NormalTextRun SCXW18618141 BCX8">(</span><span class="NormalTextRun SCXW18618141 BCX8">Nx</span><span class="NormalTextRun SCXW18618141 BCX8">=36)</span><span class="NormalTextRun SCXW18618141 BCX8">. </span><span class="NormalTextRun SCXW18618141 BCX8">D</span><span class="NormalTextRun SCXW18618141 BCX8">eep response in skin </span><span class="NormalTextRun SCXW18618141 BCX8">clearance </span><span class="NormalTextRun SCXW18618141 BCX8">and itch</span><span class="NormalTextRun SCXW18618141 BCX8"> relief</span> <span class="NormalTextRun SCXW18618141 BCX8">was achievable </span><span class="NormalTextRun SCXW18618141 BCX8">with LEB </span><span class="NormalTextRun SCXW18618141 BCX8">and </span><span class="NormalTextRun SCXW18618141 BCX8">was associated with substantial </span><span class="NormalTextRun SCXW18618141 BCX8">improvement in QOL</span><span class="NormalTextRun SCXW18618141 BCX8"> to levels </span><span class="NormalTextRun SCXW18618141 BCX8">indicating</span><span class="NormalTextRun SCXW18618141 BCX8"> minimal</span><span class="NormalTextRun SCXW18618141 BCX8">-</span><span class="NormalTextRun SCXW18618141 BCX8">to</span><span class="NormalTextRun SCXW18618141 BCX8">-</span><span class="NormalTextRun SCXW18618141 BCX8">no </span><span class="NormalTextRun SCXW18618141 BCX8">impact of AD on Q</span><span class="NormalTextRun SCXW18618141 BCX8">O</span><span class="NormalTextRun SCXW18618141 BCX8">L</span><span class="NormalTextRun SCXW18618141 BCX8">. </span></span><span class="EOP SCXW18618141 BCX8" data-ccp-props="{}"> </span></p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Raj Chovatiya, Eric Simpson, Tilo Biedermann, Leon Kircik, Vivian Y. Shi, Ignasi Figueras-Nart, Marta Casillas, Gaia Gallo, Yuxin Ding, Hong Zhang, Evangeline Pierce, Helena Agell, Christian Vestergaardhttps://skin.dermsquared.com/skin/article/view/3159Lebrikizumab vs Other Systemic Monotherapies for Moderate to Severe Atopic Dermatitis: Network Meta-analysis of Short-term Efficacy2024-11-20T15:26:36+00:00Jonathan Silverbergjonathanisilverberg@gmail.comThomas Bieberthomas.bieber@bieber-d-c.deAmy PallerAPaller@nm.orgMasahiro Kamatamkamata1122@gmail.comLuis PuigLPuig@santpau.catMarni Wisemanwiseman.marni@gmail.comKhaled Ezzedinekhaled.ezzedine@aphp.frPeter Foleypfoley@skinhealthinstitute.org.auMartin Dossenbachdossenbach_martin@lilly.comBuelent Akmazbuelent.akmaz@almirall.comMarta Casillascasillas_marta@lilly.comAndrei KarlssonAndrei.Karlsson@costellomedical.comRaj Chovatiyaraj.chovatiya@gmail.com<p><strong>Introduction:</strong> Treatment options for moderate-to-severe atopic dermatitis (AD) after inadequate response to topical therapy include biologics and Janus Kinase (JAK) inhibitors. A network meta-analysis (NMA) was conducted to evaluate the short-term efficacy of lebrikizumab relative to other monotherapies approved for moderate-to-severe AD in adults and adolescents (≥12 years).</p> <p><strong>Methods:</strong> Data were included from randomized, double-blind, placebo-controlled monotherapy trials of lebrikizumab 250 mg every 2 weeks (Q2W), dupilumab 300 mg Q2W, tralokinumab 300 mg Q2W, abrocitinib 100 or 200 mg daily, baricitinib 2 or 4 mg daily, and upadacitinib 15 or 30 mg daily. Efficacy outcomes included the proportion of patients achieving Eczema Area and Severity Index (EASI) improvement, Investigator Global Assessment of 0 or 1 (IGA 0/1), and ≥4-point improvement in pruritus/itch numeric rating scale (NRS) score at 12 weeks (abrocitinib) or 16 weeks (other treatments). A Bayesian NMA was used to estimate number needed to treat (NNT), odds ratios (ORs), probabilities, and 95% credible intervals (CrI).</p> <p><strong>Results: </strong>Twenty-two monotherapy studies involving 8531 patients were identified. For itch improvement, lebrikizumab had lower NNT values (2.90, 95% CrI: 2.26–3.80) than baricitinib 2 mg (11.12, 6.11–29.30) or 4 mg (8.10, 4.42–19.64) and tralokinumab (7.03, 4.81–11.17). Lebrikizumab had comparable NNT values for itch relative to abrocitinib 100 mg (3.50, 2.67–4.91) or 200 mg (2.31, 1.90–2.93), upadacitinib 15 mg (2.57, 2.09–3.29) or 30 mg (2.02, 1.74–2.46), and dupilumab (3.47, 2.78–4.58). NNT values for IGA 0,1 and EASI response were similar, except that upadacitinib 30 mg QD had lower NNT values than biologics at week 16. In pairwise comparisons, lebrikizumab was statistically superior to baricitinib and tralokinumab and comparable to abrocitinib, dupilumab, and upadacitinib 15 mg across all outcomes. Lebrikizumab had statistically inferior outcomes to upadacitinib 30 mg at week 16.</p> <p><strong>Conclusion: </strong>Lebrikizumab has comparable or better short-term efficacy relative to other biologics and JAK inhibitors, except for upadacitinib 30 mg. Lebrikizumab may be a highly promising first-line biologic for moderate-to-severe AD, offering patients meaningful symptom relief.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Jonathan Silverberg, Thomas Bieber, Amy Paller, Masahiro Kamata, Luis Puig, Marni Wiseman, Khaled Ezzedine, Peter Foley, Martin Dossenbach, Buelent Akmaz, Marta Casillas, Andrei Karlsson, Raj Chovatiyahttps://skin.dermsquared.com/skin/article/view/3157Race and Ethnicity Related Variations in the Social Impact and Stigma of Atopic Dermatitis Among Adults With AD: US-based Patient Survey2024-11-21T05:19:38+00:00Candrice Heathdrcandrice@drcandriceheath.comBryan Dosonobdosono@gmail.comVivian Y. Shivivian.shi918@gmail.comJennifer Soungdoctorsoung@gmail.comWendy Smith Begolkawendy@nationaleczema.orgAmber Reck Atwaterdramberatwater@gmail.comEvangeline Pierceevangeline.pierce@lilly.comElizabeth BacciElizabeth.Bacci@evidera.comJulia Correlljulia.correll@evidera.comMelissa ConstantineMelissa.Constantine@evidera.comRaj Chovatiyaraj.chovatiya@gmail.com<p> </p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Candrice Heath, Bryan Dosono, Vivian Y. Shi, Jennifer Soung, Wendy Smith Begolka, Amber Reck Atwater, Evangeline Pierce, Elizabeth Bacci, Julia Correll, Melissa Constantine, Raj Chovatiyahttps://skin.dermsquared.com/skin/article/view/3158Comparative Efficacy of Lebrikizumab, Dupilumab, and Tralokinumab in Maintaining Treatment Response in Atopic Dermatitis at Varying Treatment Continuance Rates2024-11-20T14:56:47+00:00Jonathan Silverbergjonathanisilverberg@gmail.comAlan IrvineIRVINEA@tcd.iePeter Foleypfoley@skinhealthinstitute.org.auJames Del Rossojqdelrosso@yahoo.comLuis PuigLPuig@santpau.catLinda Stein GoldLSTEIN1@hfhs.orgMartin Dossenbachdossenbach_martin@lilly.comMarta Casillascasillas_marta@lilly.comGaia Gallogallo_gaia@lilly.comBuelent Akmazbuelent.akmaz@almirall.comKim Randkrand@mathsinhealth.com<p><strong>Introduction: </strong>Atopic dermatitis (AD) is a chronic inflammatory skin disease with significant impacts on quality of life. Despite the effectiveness of biologics for moderate to severe AD, long-term treatment adherence can be challenging in clinical practice. This study introduces the “durability index” as a novel estimate of the maintenance of therapeutic effect under varying treatment continuance rates.</p> <p><strong>Methods: </strong>A population-adjusted indirect comparison of placebo-controlled phase 3 trials of dupilumab 300 mg QW/Q2W (SOLO 1, SOLO 2, and SOLO CONTINUE), tralokinumab 300 mg Q2W (ECZTRA1 and ECZTRA 2), and lebrikizumab 250 mg Q4W (ADvocate1 and ADvocate2) was conducted. In these trials, patients who responded at week 16 (IGA 0/1 or EASI 75) were re-randomized to either continue treatment or switch to treatment withdrawal (placebo) until week 52. The durability index was developed to estimate drug performance at varying treatment continuance rates between 100% to 0% on-treatment. Unanchored simulated treatment comparison (STC) was used to estimate odds ratios (OR) adjusting for baseline covariates.</p> <p><strong>Results: </strong>For IGA 0/1, patients receiving lebrikizumab had statistically significantly better odds of maintaining response at week 52 than those on dupilumab for all treatment continuance rates, ranging from 1.730 (p = 0.044) at 100% to 4.690 (p < 0.001) at 0%. ORs comparing lebrikizumab to tralokinumab ranged from 1.787 at 100% continuance to 1.516 at 0%, with significant results favoring continuance rates between 39.5% and 96.9%. For EASI 75, week-52 durability at 100% continuance was non-significantly different between lebrikizumab and dupilumab (OR 0.687, p = 0.183); however, ORs increased in favor of lebrikizumab at lower treatment continuance rates, reaching significance from 64.2% (OR 1.454, p = 0.05) to 0% (OR 3.235, p < 0.001) continuance. ORs comparing lebrikizumab to tralokinumab ranged from 2.132 at 100% to 3.891 at 0% continuance, with significant results favoring lebrikizumab for all treatment continuance rates. ORs comparing dupilumab and tralokinumab showed varying results: tralokinumab was favored for IGA 0/1 at lower continuance rates, while dupilumab was favored for EASI 75 at higher continuance rates.</p> <p><strong>Conclusions: </strong>In this indirect comparative analysis, lebrikizumab had treatment response rates that were comparable to or better than dupilumab and tralokinumab, regardless of treatment continuance rates. This finding suggests that lebrikizumab may offer a more effective long-term management option for AD.</p> <p>This analysis was funded by Eli Lilly and Company.</p>2025-01-13T00:00:00+00:00Copyright (c) 2025 Jonathan Silverberg, Alan Irvine, Peter Foley, James Del Rosso, Luis Puig, Linda Stein Gold, Martin Dossenbach, Marta Casillas, Gaia Gallo, Buelent Akmaz, Kim Rand