Say ‘No’ to Spontaneity: Treating Chronic Spontaneous Urticaria

Describe the challenges associated with second-generation antihistamine treatment for chronic spontaneous urticaria (CSU)

Discuss the latest clinical data for new therapies and emerging biologic therapies for CSU  

Identify strategies to individualize biologic treatment selection for patients with CSU

Say ‘No’ to Spontaneity: Treating Chronic Spontaneous Urticaria: An Online Activity

Describe strategies to diagnose patients with chronic spontaneous urticaria (CSU)

Describe the role of evolving therapies in the treatment and management of CSU

Identify strategies to incorporate evolving therapies for the management of CSU into dermatological clinical practice  

FC24: Evolving Therapies in the Treatment of Chronic Spontaneous Urticaria: An Online Activity

Describe strategies to diagnose patients with CSU  

Describe the complex biology of CSU and how emerging therapies target the disease pathway 

Overview the efficacy and safety of new and emerging biologics for the management of CSU  

Describe when to choose a biologic for the management of CSU  

2024 Virtual Grand Rounds Session 10: September 11, 2024 - Chronic Spontaneous Urticaria: Looking Ahead for Novel Therapies 

Describe the complex biology of CSU and how emerging therapies target the disease pathway

Overview  the efficacy and safety of new and emerging targeted therapies for the management of CSU 

Describe when to choose a targeted therapy for the management of CSU

Therapeutic Hotline: Expert Perspectives on Chronic Spontaneous Urticaria Diagnosis and Management: An Online Activity

Describe the burden of CSU and potential impacts to patient quality of life

Discuss strategies for optimizing the diagnosis of CSU

Define the role of targeted therapies for the treatment and management of CSU

Identify approaches for the delivery of optimal patient-centered care in CSU

Chronic Spontaneous Urticaria: Understanding the Burden, Diagnosis and Treatment Journey: Online CME Activity

Discuss strategies for optimizing the diagnosis of CSU 

2024 Virtual Grand Rounds Session 4: March 27, 2024 - Targeting Chronic Spontaneous Urticaria: Tips on Management

Describe strategies to diagnose patients with CSU 

Describe the role of biologics for the management of CSU

Identify strategies to incorporate biologics for the management of CSU into everyday dermatology practice 

What Dermatologist Need to Know about Chronic Spontaneous Urticaria and the Role of Biologics 

Chronic Spontaneous Urticaria (CSU)

MONDAY, May 5, 2025 (HealthDay News) -- Urticaria is seen in association with experimental HIV-1 mRNA vaccination, according to a study published online April 29 in the Annals of Internal Medicine.Sharon A. Riddler, M.D., from the University of Pittsburgh, and colleagues examined the safety and tolerability of three investigational HIV-1 trimer mRNA vaccines in a phase 1, randomized trial. A total of 108 volunteers aged 18 to 55 years without HIV-1 were randomly assigned to six vaccine groups (gp140 soluble trimer, gp151 membrane-bound trimer, and gp151 CD4KO membrane-bound trimer at doses of 100 and 250 mcg).The researchers found that mild-to-moderate local and systemic solicited events occurred frequently. A total of 190 unsolicited adverse events were reported by 80 participants; 30 were considered to be related to a study product. Overall, 73 percent of the related adverse events were mild; the rest were moderate. Of the related adverse events, urticaria was reported by seven participants (7 percent); at 12 months, four of these participants had unresolved, intermittent urticaria. No associations were seen for demographic characteristics, history of allergy or medication use, or COVID-19 with urticaria in a post-hoc analysis. Among participants with versus without urticaria, 100 versus 37 percent reported previous Moderna COVID-19 vaccination; 29 versus 76 percent reported previous Pfizer-BioNTech COVID-19 vaccination; and 0 versus 5 percent reported no previous mRNA COVID-19 vaccination."The HVTN 302 study vaccines were generally safe and tolerable, with frequent but typically mild-to-moderate local and systemic reactogenicity events, as seen previously with licensed mRNA COVID-19 vaccines," the authors write.<a target="_blank" rel="noopener noreferrer" href="https://www.acpjournals.org/doi/10.7326/ANNALS-24-02701">Abstract/Full Text</a><a target="_blank" rel="noopener noreferrer" href="https://www.acpjournals.org/doi/10.7326/ANNALS-25-01102">Editorial</a>

7 percent of 108 healthy volunteers reported urticaria; unresolved urticaria persisted at 12 months in four participants

Urticaria Reported in Trial of Investigational HIV mRNA Vaccines

<div class="raw-html-embed"><script src="https://cdn.jsdelivr.net/npm/@mux/mux-player"></script>
<mux-player playback-id="ehGwN8uHWWTI1ISPq8hBEDF92zIYlk6yLFF82Q3EvA00" metadata-viewer-user-id="Placeholder (optional)"></mux-player></div>Dr James Q Del Rosso shares insights on the latest FDA-approved indication for Dupixent (dupilumab), now approved for chronic spontaneous urticaria (CSU), highlighting key clinical data and dosing informationSanofi and Regeneron Pharmaceuticals’ Dupixent expands therapeutic options for the management of chronic spontaneous urticaria (CSU) in patients aged 12 years and older who remain symptomatic despite H1 antihistamine therapy. An injectable monoclonal antibody targeting IL-4 and IL-13 cytokines, Dupixent brings a familiar mechanism of action into the CSU treatment arsenal.CSU Treatment LandscapeChronic spontaneous urticaria affects up to 1.4% of the global population and is characterized by recurrent, unpredictable episodes of intensely itchy wheals (hives) and/or angioedema. For patients unresponsive to antihistamines, CSU can be debilitating, leaving limited options for symptom control until now.Clinical Trial InsightsApproval is backed by multiple randomized, placebo-controlled phase 3 trials known as the CUPID program (Studies A, B, and C). In Study A, involving omalizumab-naïve patients, Dupixent demonstrated statistically significant improvements in the Urticaria Activity Score over 7 days (UAS7), reducing symptoms by an average of 20.5 points compared to 12 points with placebo (P = .0003). Significant improvements were also observed in the Itch Severity Score (ISS7) and Hives Severity Score (HSS7).In Study B, which included omalizumab-incomplete responders and intolerant patients, Dupixent again showed meaningful clinical benefit with a 14.4-point reduction in UAS7 compared to 8.5 points with placebo (P = .0390), although ISS7 improvements were not statistically significant.Dr Del Rosso also notes the importance of Study C, which further reinforced Dupixent's clinical benefit in biologic-naïve patients. In Study C, Dupixent achieved significant improvements in both UAS7 and ISS7 scores versus placebo at 24 weeks, with 41% of Dupixent-treated patients achieving well-controlled disease (UAS7 ≤6) compared to 23% with placebo (P = .005), offering additional confidence in its efficacy across patient populations.Dosing for CSU follows established protocols: for patients aged 12 years and older, a loading dose based on body weight (400 mg for 30 to &lt;60 kg; 600 mg for ≥60 kg), followed by maintenance injections every 2 weeks.Safety ProfilePooled safety data from the three CUPID studies demonstrated a favorable safety profile consistent with Dupixent’s established tolerability. The most commonly reported adverse events included injection-site reactions, nasopharyngitis, and mild CSU exacerbations. Anti-drug antibodies were low and did not impact treatment outcomes.Future OutlookWith this new indication, Dupixent continues to broaden its reach across type 2 inflammatory diseases, already approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease. The CSU approval reinforces Dupixent’s role as a versatile treatment option in clinical practice.&nbsp;Maurer M, Casale TB, Saini SS, et al. Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): two randomized, double-blind, placebo-controlled, phase 3 trials. J Allergy Clin Immunol. 2024;154(1):184–194. doi:10.1016/j.jaci.2024.01.028

New FDA approval expands treatment options for chronic spontaneous urticaria patients aged 12 years and older

Launch Alert: Dupixent Approved for Chronic Spontaneous Urticaria (CSU)

WEDNESDAY, April 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adults and adolescents with chronic spontaneous urticaria.The approval is for patients 12 years and older who remain symptomatic despite histamine-1 antihistamine treatment.The approval is based on data from two phase 3 clinical studies, which included biologic-naïve patients who were symptomatic despite the use of antihistamines. Dupixent was assessed as an add-on therapy to standard-of-care antihistamines versus antihistamines alone. In both studies, Dupixent met the primary and key secondary end points, showing reductions in itch severity and urticaria activity at 24 weeks. Dupixent increased the likelihood of well-controlled disease or complete response at 24 weeks versus placebo. Safety results were generally consistent with the known safety profile of Dupixent for approved indications."Chronic spontaneous urticaria patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living," Alyssa Johnsen, M.D., Ph.D., the global therapeutic area head for immunology and oncology development at Sanofi, said in a statement. "This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms."This approval of Dupixent was granted to Sanofi.<a target="_blank" rel="noopener noreferrer" href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-18-15-15-00-3064131">More Information</a>

Approval granted for adults and children 12 years and older who remain symptomatic despite antihistamine treatment

FDA Approves Dupixent for Chronic Spontaneous Urticaria

WEDNESDAY, April 23, 2025 (HealthDay News) -- Rilzabrutinib, an oral reversible covalent Bruton tyrosine kinase inhibitor, is beneficial for treating patients with moderate-to-severe antihistamine-refractory chronic spontaneous urticaria (CSU), according to a study published online April 23 in JAMA Dermatology.Ana Giménez-Arnau, M.D., Ph.D., from the Universitat Pompeu Fabra in Barcelona, Spain, and colleagues examined the efficacy and risk profile of rilzabrutinib for patients with CSU in a phase 2 randomized study, with a 12-week, double-blind, placebo-controlled period followed by a 40-week, open-label extension. Participants aged 18 to 80 years with moderate-to-severe CSU, not adequately controlled with H1-antihistamine treatment were randomly assigned to rilzabrutinib once, twice, or three times per day (400, 800, or 1,200 mg/day) or matching placebo in a 1:1:1:1 ratio.The primary analysis population included 143 omalizumab-naive patients. The researchers observed significant reductions from baseline at week 12 in weekly Itch Severity Score (ISS7) and weekly Urticaria Activity Score (UAS7) with rilzabrutinib, 1,200 mg/day, versus placebo (least squares mean, −9.21 versus −5.77 and −16.89 versus −10.14, respectively). In addition, there were improvements in the weekly Hives Severity Score (HSS7) and weekly Angioedema Activity Score (AAS7). As early as week 1, improvements were seen in ISS7, UAS7, HSS7, and AAS7. At week 12, there was improvement noted in CSU-related biomarkers, including soluble Mas-related G protein-coupled receptor X2, compared with placebo. A favorable risk-benefit profile was seen for rilzabrutinib."Collectively, these findings offer initial evidence that the mechanism of action of rilzabrutinib may be effective in endotypes that are recalcitrant to available treatment," the authors write.Several authors disclosed ties to biopharmaceutical companies, including Sanofi, which manufactures rilzabrutinib and funded the study.Abstract/Full Text

Significant reductions seen in end points, including weekly Itch Severity Score, weekly Urticaria Activity Score

Rilzabrutinib Beneficial for Treating Chronic Spontaneous Urticaria

TUESDAY, March 11, 2025 -- For patients with symptomatic chronic spontaneous urticaria after treatment with second-generation H1-antihistamines, administration of the oral, highly selective Bruton's tyrosine kinase inhibitor, remibrutinib, results in a significant improvement in a composite measure of itching and hives at week 12, according to a study published in the March 6 issue of the New England Journal of Medicine.Martin Metz, M.D., from Charité–Universitätsmedizin Berlin, and colleagues examined the efficacy and safety of remibrutinib in patients with symptomatic chronic spontaneous urticaria after treatment with second-generation H1-antihistamines in the identical REMIX-1 and REMIX-2 trials. Patients were randomly assigned to receive remibrutinib at a dose of 25 mg twice daily or placebo (313 and 157 patients, respectively, in REMIX-1; 300 and 155 patients, respectively, in REMIX-2). The change from baseline to week 12 in the urticaria activity score during a seven-day period (UAS7), which is composed of severity scores for itch and hives during one week, was assessed as the primary end point.The researchers found that compared with the placebo group, the remibrutinib group had a significantly greater decrease in the UAS7 at week 12, which was sustained at week 24. Significantly more patients in the remibrutinib group versus the placebo group had a UAS7 score of 6 or lower at week 12 (REMIX-1: 49.8 versus 24.8 percent; REMIX-2: 46.8 versus 19.6 percent) and a UAS7 score of 0 (REMIX-1: 31.1 versus 10.5 percent; REMIX-2: 27.9 versus 6.5 percent). Adverse event rates were similar in the remibrutinib group and the placebo group, although petechiae were reported in a higher percentage of patients in the remibrutinib group than in the placebo group."These results support the efficacy and safety of remibrutinib in patients with chronic spontaneous urticaria that remained symptomatic despite treatment with second-generation H1-antihistamines," the authors write.The study was funded by Novartis, the manufacturer of remibrutinib.<a target="_blank" rel="noopener noreferrer" href="https://www.nejm.org/doi/full/10.1056/NEJMoa2408792">Abstract/Full Text (subscription or payment may be required)</a>

Remibrutinib results in significant improvement in composite measure of itching and hives at week 12 after second-generation H1-antihistamine treatment

Remibrutinib Beneficial for Urticaria After H1-Antihistamine Treatment

TUESDAY, Nov. 14, 2023 (HealthDay News) -- For patients with chronic spontaneous urticaria (CSU), acupuncture produces a greater improvement in the Weekly Urticaria Activity Score (UAS7), although the difference is not clinically significant, according to a study published online Nov. 14 in the Annals of Internal Medicine.Hui Zheng, M.D., Ph.D., from the Chengdu University of Traditional Chinese Medicine in China, and colleagues conducted a randomized, sham-controlled trial involving 330 participants diagnosed with CSU at three teaching hospitals in China. Participants were randomly assigned to receive acupuncture, sham acupuncture, or a wait-list control over an eight-week study period (four weeks of treatment and four of follow-up).The researchers found that from baseline to week 4, the mean change in UAS7 was –8.2 for acupuncture (mean score, 23.5 to 15.3). For sham acupuncture and wait-list control, the mean changes in UAS7 from baseline to week 4 were −4.1 and −2.2, respectively. Comparing acupuncture with sham acupuncture and wait-list controls, the mean differences were −4.1 and −6.1, respectively, which did not meet the threshold for minimal clinically important difference. Adverse events, which were mild and transient, were reported in 15 participants (13.6 percent) in the acupuncture group and none in other groups."This is the first description of the efficacy of acupuncture in yet another nonpain condition, albeit lacking in clinical importance in terms of the magnitude of the mean difference from baseline," Mike Cummings, M.B.Ch.B., from the British Medical Acupuncture Society in London, writes in an accompanying editorial.

However, differences between acupuncture and sham acupuncture, wait-list control did not meet threshold for minimal clinically important difference

Acupuncture Offers Some Benefit in Chronic Spontaneous Urticaria

<a target="_blank" rel="noopener noreferrer" href="https://d18uhdhjoz8by6.cloudfront.net/fcpanp23_Sanofi_Poster_1_Maurer_LIBERTY_CSU_CUPID_A_CU_Q2_Ol_566c1f77d9.pdf" download="fcpanp23_Sanofi_Poster_1_Maurer_LIBERTY_CSU_CUPID_A_CU_Q2Ol_.pdf">Click here to view poster PDF</a>Chronic spontaneous urticaria (CSU) is a chronic inflammatory disease characterized by wheals, angioedema, or both that recur for more than 6 weeks and cause itching and burning. The current standard of care is antihistamines, but many patients continue to experience disease burden despite this treatment. This poster presents data from LIBERTY-CSU CUPID Study A, a randomized, placebo-controlled, phase 3 trial of dupilumab for up to 24 weeks in patients at least 6 years of age with CSU who remain symptomatic despite treatment with antihistamines. The study found that dupilumab led to an average reduction in mean Urticaria Activity Score over 7 days (UAS7) of 20.5 points compared to a reduction of 12.0 points by placebo. Additionally, dupilumab had a mean reduction of 29.6 points in the Chronic Urticaria Quality of Life questionnaire (CU-Q2ol) compared to a reduction of 21.0 points by placebo.

In this poster presented at the 2023 Fall Clinical Dermatology Conference for PAs & NPs in Orlando, Maurer and colleagues present data from a phase 3 trial of dupilumab use for chronic spontaneous urticaria

Featured Poster: Dupilumab Improves Urticaria Signs and Symptoms and Quality of Life in Patients with Chronic Spontaneous Urticaria

In this episode of Derms and Conditions, host James Q Del Rosso, DO, engages in a comprehensive discussion with Jason Hawkes, MD, MS, FAAD, a medical dermatologist in Rocklin, CA, on chronic spontaneous urticaria (CSU). They discuss CSU’s position in the spectrum of urticarial conditions, explore differential diagnoses and treatment strategies, and offer a wealth of valuable insights into this complex disease.

In this episode of Derms and Conditions, host James Q Del Rosso, DO, engages in a comprehensive discussion with Jason Hawkes, MD, MS, FAAD, a medical dermatologist in Rocklin, CA, on chronic spontaneous urticaria (CSU). They discuss CSU’s position in the spectrum of urticarial conditions, explore differential diagnoses and treatment strategies, and offer a wealth of valuable insights into this complex disease.They begin by defining urticaria as a collection of conditions, explaining that this is often not well-delineated in textbooks or literature. Dr Hawkes categorizes urticaria into acute and chronic types, with chronic further divided into chronic inducible urticaria, which results from an identifiable trigger, and chronic spontaneous urticaria, which has no clear cause.They then explore differential diagnoses for CSU, including drug-induced urticarial reactions and conditions like mastocytosis or urticarial bullous pemphigoid that require thorough consideration.Transitioning to treatment strategies, they evaluate the use of systemic corticosteroids like prednisone for short-term relief in patients with CSU, taking into account reservations about long-term efficacy and potential side effects. Antihistamines are also highlighted for their rapid action, with Dr Hawkes encouraging prompt dosage adjustments if initial doses are ineffective.The conversation shifts to omalizumab, an injectable anti-IgE monoclonal antibody that has waned in popularity among dermatologists due to practical limitations and concerns over anaphylaxis risk. However, it is highlighted as a very effective treatment option for many patients with CSU, as it is amenable to office administration with low rates of anaphylaxis in real-world practice and has a broad consensus for use in guidelines.They conclude by touching on newer therapies in development that target alternative mechanisms, such as BTK and SYK inhibitors, which will broaden the therapeutic alternatives for patients with CSU.Tune into the full episode to gain a deeper understanding of CSU and glean invaluable insights into the nuances of this multifaceted condition.

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