Discuss the latest clinical and comparative data for new and emerging biologic agents for psoriatic arthritis (PsA)

Identify optimal clinical decision-making approaches for patients with PsA who have not responded to initial biologic therapy

Review strategies for shared decision-making to counsel patients with PsA who have failed previous treatment with biologic therapy

2024 Virtual Grand Rounds Session 13: October 9, 2024 - New Conversations in Psoriatic Arthritis: Overcoming Treatment Failure

Psoriatic Arthritis

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</div>Watch to hear Dr James Del Rosso’s expert take on Bimzelx (bimekizumab) for psoriatic arthritis, including insights on clinical trial data, safety, and more.&nbsp;In September 2024, the US Food and Drug Administration (FDA) approved Bimzelx (bimekizumab-bkzx) for the treatment of active psoriatic arthritis (PsA) in adults. This approval introduced a treatment option for PsA with a dual-targeted mechanism that selectively inhibits both IL-17A and IL-17F, 2 key cytokines driving inflammatory processes. Bimzelx is also approved for the treatment of adults with moderate-to-severe plaque psoriasis, active nonradiographic axial spondyloarthritis, active ankylosing spondylitis, and moderate-to-severe hidradenitis suppurativa.&nbsp;Clinical data highlights&nbsp;Bimzelx’s approval was backed by robust data from two Phase 3 trials, BE OPTIMAL and BE COMPLETE, which demonstrated statistically significant results in both biologic disease-modifying anti-rheumatic drug (bDMARD-naive) and TNF inhibitor-inadequate responder (TNFi-IR) populations.&nbsp;Key findings&nbsp;<ul><li>Joint symptoms (ACR50): At Week 16, 44% of bDMARD-naive patients and 43% of TNFi-IR patients receiving Bimzelx achieved ACR50, compared to 10% and 7% of patients receiving placebo, respectively&nbsp;</li><li>Minimal disease activity (MDA): Bimzelx delivered MDA in 45% of bDMARD-naive patients and 44% of TNFi-IR patients at Week 16, versus 13% and 6% in the placebo groups, with clinical responses generally sustained to Week 52&nbsp;</li><li>Complete skin clearance (PASI100): Among patients with baseline psoriasis affecting ≥3% of their body surface area, 47% of bDMARD-naive patients and 59% of TNFi-IR patients achieved PASI100 at Week 16, compared to 2% and 5% in the placebo groups, with clinical responses generally sustained to Week 52&nbsp;</li></ul>Safety snapshot&nbsp;Bimzelx demonstrated a safety profile consistent with prior studies. The most common adverse reactions (≥2%) included upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections.&nbsp;Key takeaways&nbsp;<ul><li>Mechanism of action: Bimzelx is the first FDA-approved PsA treatment targeting both IL-17A and IL-17F&nbsp;</li><li>Efficacy: In clinical trials, Bimzelx showed significant improvements in ACR50, MDA, and PASI100 by Week 16, with sustained results through Week 52&nbsp;</li><li>Safety: Common adverse reactions include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections&nbsp;</li><li>Impact: Bimzelx provides a versatile option for biologic-naive and TNFi-inadequate responders</li></ul>

CLICK HERE to watch Dr James Del Rosso’s dermatologic deep dive on Bimzelx (bimekizumab) for psoriatic arthritis

In Case You Missed It: FDA Approves Bimzelx for Psoriatic Arthritis

MONDAY, May 13, 2024 (HealthDay News) -- Psoriatic arthritis (PsA) and atopic dermatitis (AD) can coexist, and the presence of both conditions may mean special attention should be given to selecting optimal treatment, according to a study published online April 17 in the Journal of Personalized Medicine.Georgiana Strugariu, from "Grigore T. Popa" University of Medicine and Pharmacy in Romania, and colleagues examined AD in patients with PsA and receiving biologics for their active disease in a retrospective analysis of 64 patients with PsA. Participants were followed in an outpatient rheumatology department for up to 10 years.The researchers found that about one-third of the patients had atopic diseases, with a higher incidence of AD versus atopic rhinitis and allergic asthma (10 cases versus six and three cases, respectively [52.6 percent versus 31.6 and 15.8 percent, respectively]). Within AD, three morphological patterns were recognized, including chronic prurigo, a chronic lichen simplex, and eczemas (three, one, and six cases, respectively). Late onset of skin atopy was seen for all PsA patients with concomitant AD (in adult life), and they exhibited a specific profile, including being younger, being from urban settings, being equally distributed among genders, and requiring switching to a higher number of biologics in order to achieve disease control.&nbsp;"Screening patients with psoriasis and PsA for atopy and for AD could play an important role in creating a more specific profile of respondents to a particular therapeutic class and give these patients the chance for better control and a longer therapeutic response," the authors write.<a target="_blank" rel="noopener noreferrer" href="https://www.mayoclinicproceedings.org/article/S0025-6196(24)00053-3/fulltext">Abstract/Full Text</a>

One-third of psoriatic arthritis patients have atopic diseases, most often dermatitis versus atopic rhinitis and allergic asthma

Coexistence of Psoriatic Arthritis, Atopic Dermatitis May Offer Treatment Insights

FRIDAY, Aug. 11, 2023 (HealthDay News) -- The development of psoriatic arthritis (PsA) can be predicted with reasonable accuracy for psoriasis patients, according to a study published online Aug. 9 in Arthritis &amp;Rheumatology.Lihi Eder, M.D., Ph.D., from University of Toronto, and colleagues developed a risk prediction model (PRESTO) for the development of PsA among individuals with psoriasis.The researchers reported that among 635 patients with psoriasis, 51 developed PsA at one year and 71 at five years. At one year, the risk for developing PsA was associated with younger age, male sex, family history of psoriasis, back stiffness, nail pitting, joint stiffness, use of biologic medications, patient global health, and pain severity (area under the curve, 72.3). At five years, the risk for developing PsA was associated with morning stiffness, psoriatic nail lesion, psoriasis severity, fatigue, pain, and use of systemic nonbiologic medication or phototherapy (area under the curve, 74.9). There was reasonable agreement between predicted and observed probabilities."[PRESTO] can also identify patients with psoriasis who can benefit from early treatments, and it can serve as an educational tool for patients to increase awareness of psoriatic arthritis risk," Eder said in a statement. "Ultimately, we hope that these efforts will improve the lives of people living with psoriatic disease."Several authors disclosed ties to the pharmaceutical industry.

Model relies on readily available clinical variables

Model Predicts New Psoriatic Arthritis in People With Psoriasis

FRIDAY, Aug. 11, 2023 (HealthDay News) -- Psoriasis is associated with rheumatic diseases, according to a study published online Aug. 5 in the Journal of the American Academy of Dermatology.Mimi Chung, from the University of California in San Francisco, and colleagues conducted a cross-sectional cohort study using the U.S.-based racially and ethnically diverse All of Us national database to examine the association between psoriasis and rheumatic diseases. Rheumatic diseases of interest were identified in two cohorts: a psoriasis group with two or more diagnoses of psoriasis and a control group without a diagnosis of psoriasis.The researchers identified a significant association for psoriasis with psoriatic arthritis (PsA), osteoarthritis, gout, fibromyalgia, rheumatoid arthritis, ankylosing spondylitis, Sjogren syndrome, and systemic sclerosis. Due to clinical overlap between PsA and other rheumatic conditions, the percentage of PsA patients diagnosed with concomitant diseases was examined; common codiagnosis included osteoarthritis, rheumatoid arthritis, and fibromyalgia (47.6, 15.1, and 12.7 percent, respectively)."Co-occurrence of psoriasis and rheumatic diagnoses may in part be due to common underlying mechanisms such as higher body mass index," the authors write. "Of note, however, [psoriasis] was associated with an increased odds of rheumatic disease compared to controls even after adjustment for body mass index."Several authors disclosed ties to the pharmaceutical industry.

Psoriasis significantly linked to psoriatic arthritis, osteoarthritis, gout, fibromyalgia, RA, ankylosing spondylitis, Sjogren syndrome, systemic sclerosis

Co-Occurrence of Psoriasis and Rheumatic Diseases Common

THURSDAY, May 18, 2023 (HealthDay News) -- For patients with moderately to severely active psoriatic arthritis, the tyrosine kinase 2/Janus kinase 1 inhibitor brepocitinib is effective for reducing symptoms, according to a study published online May 17 in Arthritis &amp; Rheumatology.Philip Mease, M.D., from the University of Washington in Seattle, and colleagues conducted a placebo-controlled trial involving participants with moderately to severely active psoriatic arthritis. Two hundred eighteen participants were randomly assigned to brepocitinib 10 mg once daily (QD), 30 mg QD, 60 mg QD, or placebo, advancing to brepocitinib 30 or 60 mg QD at week 16.The researchers found that brepocitinib 30 and 60 mg QD groups had significantly greater American College of Rheumatology (ACR)20 response rates at week 16 versus placebo (66.7 and 74.6 percent, respectively, versus 43.3 percent) and had significantly higher ACR50/70, 75 percent and 90 percent improvement in Psoriasis Area and Severity Index, and Minimal Disease Activity response rates. Through week 52, response rates were maintained or improved. Adverse events were mostly mild/moderate; in 12 participants, serious adverse events occurred, including infections in six participants in the brepocitinib 30- and 60-mg QD groups. There were no major adverse cardiovascular events or deaths reported."These data demonstrate striking efficacy and confirm the relevance of multiple signaling pathways dependent on the kinases targeted by brepocitinib in psoriatic arthritis," Mease said in a statement. "The safety is also reassuring for brepocitinib in this study."Several authors disclosed financial ties to pharmaceutical companies, including Pfizer, which manufactures brepocitinib and funded the study.

Significantly greater ACR20 response rates seen at week 16 for 30 and 60 mg QD versus placebo; response maintained or improved at 52 weeks

Brepocitinib Beneficial for Moderate-to-Severe Psoriatic Arthritis

Risankizumab provides long-term benefits in patients with psoriatic arthritis (PsA) who have not achieved adequate response to previous therapies, according to a study recently published in
 
 Rheumatology
 
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 Andrew Östör, M.D., from Monash University in Melbourne, Australia, and colleagues evaluated the 52-week efficacy and safety of risankizumab in patients with active PsA who had previous inadequate response/intolerance to one or two biologic therapies or one or more conventional, synthetic disease-modifying antirheumatic drugs. Patients were randomly assigned to risankizumab or placebo at weeks 0, 4, and 16, with all patients receiving risankizumab every 12 weeks from weeks 28 to 208.




 The researchers found that at week 24, 51.3 percent of risankizumab-treated patients (224 patients) achieved ≥20 percent improvement in American College of Rheumatology criteria (ACR20) versus 26.5 percent of placebo-treated patients (220 individuals). ACR20 was achieved at week 52 by 58.5 percent of patients on continuous risankizumab versus 55.7 percent of patients who switched from placebo to risankizumab at week 24. Other efficacy measures showed similar trends. Through week 52, rates of serious treatment-emergent adverse events (TEAEs) and TEAEs leading to discontinuation remained stable, with no deaths reported.




 "Notably, efficacy was maintained with administration of risankizumab every 12 weeks, while similar interleukin-23 inhibitors are administered every eight weeks," the authors write.




 Several authors disclosed financial ties to pharmaceutical companies, including AbbVie, which manufactures risankizumab and funded the study.




 <a class="rm-stats-tracked" href="https://academic.oup.com/rheumatology/advance-article/doi/10.1093/rheumatology/keac605/6772503" target="_blank">
 Abstract/Full Text
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Long-term benefits seen in patients with inadequate response/intolerance to biologic or conventional disease-modifying antirheumatic drugs

Risankizumab Safe, Effective at 52 Weeks for Psoriatic Arthritis

The U.S. Food and Drug Administration has expanded the approval of Skyrizi (risankizumab-rzaa) to treatment of adults with active psoriatic arthritis, the manufacturer announced Friday.




 The dosing regimen of Skyrizi for psoriatic arthritis is consistent with the regimen for moderate-to-severe plaque psoriasis, which is a single 150-mg subcutaneous injection four times a year following two starter doses at weeks 0 and 4. Skyrizi can be administered alone or in combination with disease-modifying antirheumatic drugs (DMARDs).




 The approval was based on data from the KEEPsAKE-1 and KEEPsAKE-2 phase 3 studies, which enrolled patients with active psoriatic arthritis, some of whom had responded inadequately or were intolerant to biologic therapy or nonbiologic DMARDs. In a press release announcing the approval, the manufacturer said 57.3 and 51.3 percent of patients receiving Skyrizi in the KEEPsAKE-1 and KEEPsAKE-2 trials, respectively, achieved the primary end point of ACR20 response at week 24 compared with 33.5 and 26.5 percent of patients receiving placebo. Skyrizi also showed improvement compared with placebo in dactylitis and enthesitis as well as improvements in skin lesions of psoriasis as measured by the Psoriasis Area Severity Index 90 at week 24 in patients with coexistent plaque psoriasis.




 The most common side effects of Skyrizi include upper respiratory infections, fatigue, fungal skin infections, headache, and injection site reactions. Skyrizi may also increase the risk for infections. Health care providers should check patients for infections and tuberculosis before initiating treatment.




 Approval was granted to AbbVie.




 <a class="rm-stats-tracked" href="https://news.abbvie.com/news/press-releases/us-fda-approves-second-indication-for-skyrizi-risankizumab-rzaa-to-treat-adults-with-active-psoriatic-arthritis.htm" target="_blank">
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Approval based on two Phase 3 trials showing more than 50 percent of patients receiving Skyrizi achieved ACR20 response at 24 weeks

Skyrizi Approved for Psoriatic Arthritis

In Episode 30 of Derms and Conditions, host James Q. Del Rosso, DO speaks with Joseph Merola, MD, MMSc, a board certified rheumatologist and dermatologist. They discuss the diagnosis and management of cutaneous lupus and key diagnostic tips for psoriatic arthritis.

In Episode 30 of Derms and Conditions, host James Q. Del Rosso, DO speaks with Joseph Merola, MD, MMSc, a board certified rheumatologist and dermatologist who is an Associate Professor of Dermatology at Harvard Medical School. Dr. Merola and Dr. Del Rosso first discuss the diagnosis and management of cutaneous lupus with a special focus on drug-induced lupus. Next, Dr. Del Rosso asks Dr. Merola about dermatomyositis including tips on diagnosis and which laboratory tests are best to order. Finally, Dr. Merola ends the episode with a focus on psoriatic arthritis, including key diagnostic tips to help differentiate it from other arthritic disorders. FINANCIAL DISCLOSURES: James Q. Del Rosso, DO CONSULTANT/ADVISOR Abbvie, Aclaris, Almirall, Amgen, Arcutis, Bausch Health (Ortho Dermatology), BioFrontera, BioPharmX, Bristol-Myers-Squibb, Cassiopea, Dermata, Dermavant, Encore, EPI Health, Evommune, Ferndale, Galderma, Incyte, JEM Health, Leo Pharma, La Roche Posay, Lilly (Dermira), MC2, Novan, Pfizer, Regeneron, Sanofi-Genzyme, SolGel, Sonoma (IntraDerm), Sun Pharma, Trevi, UCB, Verrica, Vyne (Foamix; Menlo) SPEAKER BUREAU Aclaris, Almirall, Amgen, Arcutis, Bausch Health (Ortho Dermatology), EPI Health, Ferndale, Galderma, Genentech, JEM Health, Leo Pharma, La Roche Posay, Lilly (Dermira), Pfizer, Regeneron, Sanofi-Genzyme, Sun Pharma, UCB, Verrica, Vyne (Foamix; Menlo) RESEARCH INVESTIGATOR Aclaris, Almirall, Amgen, Anaptys Bio, Arcutis, Athenex, Bausch Health (Ortho Dermatology), BioPharmX, Biorasi, Botanix, Brickell, Cara Therapeutics, Cassiopea, Dermavant, EPI Health, Ferndale, Galderma, Incyte, Leo Pharma, Lilly (Dermira), Novan, Pfizer, Ralexar, Regeneron, SolGel, Sun Pharma, UCB, Verrica, Vyne (Foamix; Menlo). Joseph F. Merola, MD, MMSc Consultant/Investigator and/or Research funding&mdash;Amgen, BMS, Avotres, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Sanofi, Regeneron, Biogen, Pfizer, Leo Pharma.

Derms and Conditions Podcast

The Smartest One in the Rheum: A Conversation with Joseph Merola, MD, MMSc

Psoriasis & Psoriatic Arthritis – So Now What Do I Do?

You. I'm Bonnie Aluski, professor and chair of dermatology at the University of Alabama in Birmingham. Today we talked about Il 23 blockers. There are four IL 23 blockers. Eusticinumab, which blocks P 43, that block P 19. Risen, kizumab, tildrakizumab, and guselchumab, which I call for short. Gus, tilly and Risen. They all have in common that they're dependable, reliable. They have lasting efficacy because they control the master cytokine for IL 17. It knocks out the cells, and because you knock out the cells, you don't have to give the drug that often. You can do infrequent dosing. So these are dosed every two to three months. If you give an IL 17 blocker, it blocks the 17, but IL 17 continues to be produced. So you have to keep giving the IL 17 blocker on a regular basis. So IL 23 blockers have the advantage of infrequent dosing. They're reliable. They don't have a signal for candida. They can actually be used to treat IBD, so they don't trigger IBD as the IL 17s might, and they're safe and effective. Hi, I'm Erin Bow. And I'm Christina Callistuffin. Today we both talked about drugs that we use in treating our patients with psoriasis and psoriatic arthritis. I spoke about maybe using oral agents and where is it appropriate to use them. And I suggested that you use your oral agents, which are easy to use with very little monitoring, in patients who may have limited skin disease, three to 5%. Or those patients who might be afraid to jump into doing biologics, or they don't want to have frequent lab testing. Both of the newer agents, the pramalast, as well as ducravacitinib, are indicated for psoriasis. They have very good safety profiles, they have very good efficacy when compared to each other, as well as to other agents, like the traditional agents. So for those patients who aren't willing or not able or have contraindications to some of the biologics which Kristung will talk about, we're going to use these oral agents, and patients can get quite satisfactory results with those agents. My part of the talk was on utilizing anti TNF or tumor necrosis factor alpha agents in patients with psoriasis and psorio arthritis. I discussed a case of a patient who had started with traditional agents and then transitioned to different and through different tnf alpha inhibitors. And specifically to illustrate my point, he developed psoria arthritis after he'd failed several oral and biologic agents and now is on certiligumab, which is one of our tnf alpha agents that, at a psoriasis dose, is working well for his skin and his joint. So I was illustrating the points that patients who have skin disease often will do okay on a tnf agent and do well from a joint perspective on a tnf agent. And sometimes when they're on an aisle 1223 or 23 inhibitor or a 17, their joints flare up at the end of the day. I was making some points about the fact that patients on TNF inhibitors can do well even after failing one, two, or three TNF agents. If they have contraindications, obviously, you might not want to go there. And specifically if they have axial disease, this is a very good class of drug.

In this 4-part lecture, Boni E. Elewski, MD, April W. Armstrong, MD, MPH, Erin E. Boh, MD, PhD, and Kristina Callis Duffin, MD, provided the audience with clinical pearls for treating patients with psoriasis who also have psoriatic arthritis. Dr Elewski began with a tip for treating college students with psoriasis. Interleukin-23 blockers, such as guselkumab, risankizumab, and tildrakizumab, offer reliable, high-efficacy, and convenient dosing schedules for patients who will be away at school. With a proven safety profile, including no contraindication for irritable bowel disease, these medications are a great choice for college students. IL-23 blockers have also been proven effective for psoriatic arthritis in clinical studies.Dr Armstrong continued the discussion with a pearl for treating erythrodermic psoriasis with severe joint pain. Erythrodermic psoriasis, while rare, can commonly result in nail dystrophy, arthralgias, and lab abnormalities. Ixekizumab, an IL-17 inhibitor, has rapid and robust efficacy in psoriasis, as well as a pediatric indication for psoriasis down to 6 years of age. Ixekizumab was also shown to inhibit radiographic progression of psoriatic arthritis in clinical trials and is effective for both peripheral and axial disease. If complete clearance of erythrodermic psoriasis is not achieved after 3 months, Dr Armstrong recommended adding deucravacitinib to boost efficacy.&nbsp;Moving on to oral agents, Dr Boh reviewed efficacy data for apremilast and deucravacitinib. Apremilast is an oral phosphodiesterase-4 inhibitor approved for both psoriasis and psoriatic arthritis, with no lab monitoring required except in patients with end-stage renal disease. Apremilast exhibited durable treatment responses in clinical trials, with 44% of patients maintaining PASI-75 responses at Week 206. Deucravacitinib is an oral TYK-2 inhibitor that blocks downstream IL-23 signaling and is approved as a once-daily pill for psoriasis. Exhibiting robust efficacy, deucravacitinib 6 mg led to PASI-75 rates of 53% to 58% at Week 16 in clinical trials. To conclude, Dr Boh provided tips on how to use both of these oral medications in combination with biologic therapies.To finish the session, Dr Duffin discussed indications and efficacy data for the oldest class of biologic medications, TNF-a inhibitors. With over 20 years of history for this class of medication, TNF-a inhibitors are a pillar of psoriasis and psoriatic arthritis treatment. While IL-23 inhibitors and IL-17 inhibitors may have higher rates of skin clearance, TNF-a inhibitors consistently show the highest rates of joint disease control among the approved biologic medications and should be considered as first-line treatments for axial psoriatic arthritis. TNF-a inhibitors have a few unique characteristics to remember, including the youngest indication (etanercept down to age 4) and proven safety in pregnancy and lactation with certolizumab pegol.

How does Taltz compare head to head with Humira for psoriatic arthritis?

You in an a headtohead study sponsored by Lily TLTz performed better in terms of an aggregate score of ACR 50 and passy 100 compared to Humira.

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