ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1137

Deucravacitinib, an Oral,Selective,Allosteric Tyrosine Kinase 2 Inhibitor, in Patients WithModerate to Severe Scalp Psoriasis: Efficacy and Safety Results of a Phase 3b/4, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial (PSORIATYK SCALP)

Kristina Callis Duffin1, Christopher E. M. Griffiths2, Matthias Hoffmann3, Andrew Blauvelt4, Eugene Balagula5, Andrew Napoli5, Ying-Ming Jou5, Rachel Dyme5, Virginia Hala5, andreas pinter6 and Mark Lebwohl7, 1University of Utah, Salt Lake City, 2Dermatology Centre, University of Manchester, Manchester, and King’s College Hospital and King’s College London, London, United Kingdom, 3Private Practice, Witten, Germany, 4Oregon Medical Research Center, Portland, OR, 5Bristol Myers Squibb, Princeton, 6University Hospital of the Goethe University, Frankfurt am Main, Frankfurt, Germany, 7Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY

Meeting: ACR Convergence 2024

Keywords: , , , ,

Session Information

Date: Sunday, November 17, 2024

Title: Miscellaneous Rheumatic & Inflammatory Diseases Poster II

Session Type: Poster Session B

Session Time: 10:30AM-12:30PM

Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate to severe plaque psoriasis.

Methods: Adults with moderate to severe scalp psoriasis (Scalp-Specific Physician Global Assessment [ss-PGA] ≥ 3, scalp surface area ≥ 20%, Psoriasis Scalp Severity Index [PSSI] ≥ 12, and body surface area [BSA] ≥ 3%) were randomized 1:2 to placebo or deucravacitinib 6 mg once daily. The primary efficacy outcome was ss-PGA 0/1 at week 16; key secondary outcomes were a ≥ 90% improvement from baseline in PSSI (PSSI 90), change from baseline (CFB) in scalp-specific itch, and static Physician Global Assessment (sPGA) 0/1 at week 16. Efficacy outcomes were evaluated for the overall population and the subpopulation with global sPGA ≥ 3.

Results: 154 patients were randomized (placebo, n = 51; deucravacitinib, n = 103). Baseline characteristics were similar in each group (placebo: Psoriasis Area and Severity Index [PASI] 9.4, PSSI 32.2, BSA 10.0%; deucravacitinib: PASI 10.2, PSSI 33.5, BSA 10.5%). In the overall population, deucravacitinib was superior to placebo with statistical significance achieved for all primary and secondary efficacy outcomes at week 16: ss-PGA 0/1 (48.5% vs 13.7%; P < 0.0001), PSSI 90 (38.8% vs 2.0%; P < 0.0001), and mean CFB in scalp-specific itch (−3.2 vs −0.7; P < 0.0001). In patients with sPGA ≥ 3, a greater proportion achieved sPGA 0/1 with deucravacitinib vs placebo (51.0% vs 4.3%; P < 0.0001). The most common adverse events with deucravacitinib were nasopharyngitis (14.6%), upper respiratory tract infection (11.7%), acne (9.7%), headache (7.8%), COVID-19 (5.8%), and pustular acne (5.8%). Two serious adverse events occurred (atrial fibrillation and meniscus injury; neither was treatment related or led to discontinuation).

Conclusion: Deucravacitinib was efficacious and well tolerated in patients with moderate to severe scalp psoriasis, including those with less extensive overall psoriasis. These findings are consistent with the POETYK trials and support the use of deucravacitinib in scalp psoriasis.

Disclosures: K. Duffin: AbbVie, 2, 12, Investigator, Amgen/Celgene, 2, 12, Investigator, Boehringer Ingelheim, 2, 12, Investigator, Bristol Myers Squibb, 2, 6, CorEvitas Psoriasis Registry, 2, Janssen, 2, 12, Investigator, Leo Pharma, 2, Lilly, 2, 12, Investigator, Novartis, 2, 6, 12, Investigator, Pfizer, 2, 12, Investigator, Regeneron, 12, Investigator, Stiefel, 2, 12, Investigator, UCB, 12, Investigator; C. Griffiths: AbbVie, 5, Almirall, 5, Amgen, 5, AnaptysBio, 5, Boehringer Ingelheim, 5, Bristol Myers Squibb, 5, Evelo Biosciences, 5, GSK, 5, Inmagene, 5, Janssen, 5, Kyowa Kirin, 5, Leo Pharma, 5, Lilly, 5, Novartis, 5, ONO Pharmaceuticals, 5, Pfizer, 5, Sanofi, 5, UCB, 5; M. Hoffmann: AbbVie, 1, 2, 12, Investigator, ALK, 12, Investigator, Almirall, 1, 2, Alumis, 12, Investigator, Amgen, 12, Investigator, Biogen, 12, Investigator, Boehringer Ingelheim, 12, Investigator, Bristol Myers Squibb, 12, Investigator, Dermasence, 1, 2, 12, Investigator, Dermira, 12, Investigator, Forward, 12, Investigator, Galderma, 1, 2, 12, Investigator, Incyte, 1, 2, 12, Investigator, Janssen, 1, 2, 12, Investigator, Kiniksa, 12, Investigator, Leo Pharma, 1, 2, 12, Investigator, Leti Pharma, 1, 2, 12, Investigator, Lilly, 12, Investigator, Meda Pharma, 12, Investigator, Medac, 12, Investigator, Meiji Pharma, 12, Investigator, MSD, 12, Investigator, Nektar Therapeutics, 12, Investigator, Novartis, 1, 2, 12, Investigator, Pfizer, 1, 2, 12, Investigator, Pierre Fabre, 12, Investigator, Sanofi, 1, 2, 12, Investigator, Schering-Plough, 12, Investigator, Smerud Medical Research, 12, Investigator, Stallergenes Greer, 12, Investigator, UCB, 1, 2, 12, Investigator; A. Blauvelt: AbbVie, 1, 12, Clinical Study Investigator, Abcentra, 1, Acelyrin, 12, Clinical Study Investigator, Aclaris, 1, Affibody, 1, Aligos, 1, Allakos, 12, Clinical Study Investigator, Almirall, 1, 12, Clinical Study Investigator, Alumis, 1, 12, Clinical Study Investigator, Amgen, 1, 12, Clinical Study Investigator, Apogee, 1, Arcutis, 1, 12, Clinical Study Investigator, Arena, 1, Aslan, 1, Athenex, 1, 12, Clinical Study Investigator, Bluefin Biomedicine, 1, Boehringer Ingelheim, 1, 12, Clinical Study Investigator, Bristol Myers Squibb, 1, 12, Clinical Study Investigator, Cara Therapeutics, 1, Celldex, 1, Concert, 12, Clinical Study Investigator, CTI BioPharma, 1, Dermavant, 1, 12, Clinical Study Investigator, DermBiont, 12, Clinical Study Investigator, EcoR1, 1, Eli Lilly, 1, 6, 12, Clinical Study Investigator, Escient, 1, Evelo Biosciences, 1, 12, Clinical Study Investigator, Evommune, 1, 12, Clinical Study Investigator, Forte Biosciences, 1, Galderma, 1, 12, Clinical Study Investigator, HighlightII Pharma, 1, Incyte, 1, 12, Clinical Study Investigator, InnoventBio, 1, Janssen, 1, 12, Clinical Study Investigator, Landos, 1, LEO Pharma, 1, 12, Clinical Study Investigator, Lipidio, 1, 11, 12, Clinical study investigator, Merck, 1, 12, Clinical Study Investigator, Microbion, 1, Monte Rosa, 1, Nektar, 1, Novartis, 1, 12, Clinical Study Investigator, Oruka, 11, Overtone Therapeutics, 1, Paragon, 1, Pfizer, 1, 12, Clinical Study Investigator, Q32 Bio, 1, Rani, 1, Rapt, 1, Regeneron, 1, 12, Clinical Study Investigator, Sanofi, 12, Clinical Study Investigator, Sanofi Genzyme, 1, Spherix Global Insights, 1, Sun Pharma, 1, 12, Clinical Study Investigator, Takeda, 1, 12, Clinical Study Investigator, TLL Pharmaceutical, 1, TrialSpark, 1, UCB, 1, 6, 12, Clinical Study Investigator, Union, 1, Ventyx, 1, 12, Clinical Study Investigator, Vibliome, 1, Xencor, 1; E. Balagula: Bristol Myers Squibb, 3, 8; A. Napoli: Bristol Myers Squibb, 3, 8; Y. Jou: Bristol Myers Squibb, 3, 8; R. Dyme: Bristol Myers Squibb, 3, 8; V. Hala: Bristol Myers Squibb, 3, 8; a. pinter: AbbVie, 1, 6, 12, Clinical trials, Almirall-Hermal, 1, 6, 12, Clinical trials, Amgen, 1, 6, 12, Clinical trials, Biogen Idec, 1, 6, 12, Clinical trials, Biontec, 1, 6, 12, Clinical trials, Boehringer Ingelheim, 1, 6, 12, Clinical trials, Bristol Myers Squibb, 1, 6, 12, Clinical trials, Celgene, 1, 6, 12, Clinical trials, Celltrion, 1, 6, 12, Clinical trials, Eva Pharma, 1, 6, 12, Clinical trials, Galderma, 1, 6, 12, Clinical trials, GSK, 1, 6, 12, Clinical trials, Hexal, 1, 1, 6, 6, 12, Clinical trials, 12, Clinical trials, Janssen-Cilag, 1, 6, 12, Clinical trials, Klinge Pharma, 1, 6, 12, Clinical trials, Leo Pharma, 1, 6, 12, Clinical trials, Lilly, 1, 6, 12, Clinical trials, MC2, 1, 6, 12, Clinical trials, Medac, 1, 6, 12, Clinical trials, Merck, 1, 6, 12, Clinical trials, Merck Serono, 1, 6, 12, Clinical trials, Mitsubishi, 1, 6, 12, Clinical trials, MoonLake Immunotherapeutics, 1, 6, 12, Clinical trials, Novartis, 1, 6, 12, Clinical trials, Pascoe, 1, 6, 12, Clinical trials, Pfizer, 1, 6, 12, Clinical trials, Regeneron, 1, 6, 12, Clinical trials, Roche, 1, 6, 12, Clinical trials, Sandoz, 1, 6, 12, Clinical trials, Sanofi Genzyme, 1, 6, 12, Clinical trials, Schering Plough, 1, 6, 12, Clinical trials, Tigercat Pharma, 1, 6, 12, Clinical trials, UCB, 1, 6, 12, Clinical trials, Züllig Pharma, 1, 6, 12, Clinical trials; M. Lebwohl: AbbVie, 5, Almirall, 2, AltruBio Inc., 2, Amgen, 5, AnaptysBio, 2, Arcutis, 2, 5, AstraZeneca, 2, Avotres, 2, 5, Boehringer Ingelheim, 2, 5, Brickell Biotech, 2, Bristol Myers Squibb, 2, Cara Therapeutics, 5, Castle Biosciences, 2, Celltrion, 2, CorEvitas, 2, Dermavant Sciences, 2, 5, Eli Lilly, 5, EPI, 2, Evommune Inc., 2, Facilitation of International Dermatology Education, 2, Forte Biosciences, 2, Foundation for Research and Education in Dermatology, 2, Galderma, 2, Genentech, 2, Incyte, 2, 5, Inozyme, 5, Janssen, 5, LEO Pharma, 2, LLC, 5, Meiji Seika Pharma, 2, Mindera, 2, Mount Sinai, 3, Ortho Dermatologics, 5, Pfizer, 2, Sanofi-Regeneron, 5, Seanergy, 2, Strata, 2, Trevi, 2, UCB Pharma, 5, Verrica, 2.

To cite this abstract in AMA style:

Duffin K, Griffiths C, Hoffmann M, Blauvelt A, Balagula E, Napoli A, Jou Y, Dyme R, Hala V, pinter a, Lebwohl M. Deucravacitinib, an Oral,Selective,Allosteric Tyrosine Kinase 2 Inhibitor, in Patients WithModerate to Severe Scalp Psoriasis: Efficacy and Safety Results of a Phase 3b/4, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial (PSORIATYK SCALP) [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/deucravacitinib-an-oralselectiveallosteric-tyrosine-kinase-2-inhibitor-in-patients-withmoderate-to-severe-scalp-psoriasis-efficacy-and-safety-results-of-a-phase-3b-4-multicenter-randomized-dou/. Accessed .

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