1. Deucravacitinib, a selective, allosteric tyrosine kinase 2 inhibitor, in scalp psoriasis: A subset analysis of two phase 3 randomized trials in plaque psoriasis.
- Author
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Blauvelt A, Rich P, Sofen H, Strober B, Merola JF, Lebwohl M, Morita A, Szepietowski JC, Lambert J, Hippeli L, Colston E, Balagula E, Banerjee S, and Thaçi D
- Subjects
- Adult, Humans, Double-Blind Method, Randomized Controlled Trials as Topic, Scalp, Severity of Illness Index, Treatment Outcome, TYK2 Kinase antagonists & inhibitors, Heterocyclic Compounds adverse effects, Heterocyclic Compounds therapeutic use, Phosphodiesterase 4 Inhibitors adverse effects, Phosphodiesterase 4 Inhibitors therapeutic use, Psoriasis drug therapy, Thalidomide analogs & derivatives, Thalidomide therapeutic use
- Abstract
Background: Scalp involvement in plaque psoriasis is challenging to treat., Objective: To evaluate the efficacy and safety of deucravacitinib (DEUC) in scalp psoriasis., Methods: POETYK PSO-1 and PSO-2 were global phase 3, 52-week, double-blinded trials in adults with moderate to severe psoriasis. Patients were randomized 1:2:1 to oral placebo, DEUC 6 mg once daily, or apremilast 30 mg twice daily. This pooled secondary analysis evaluated scalp-specific Physician Global Assessment score of 0 or 1 (0/1), ≥90% improvement from baseline in Psoriasis Scalp Severity Index, and change from baseline in Psoriasis Scalp Severity Index. Adverse events were evaluated through week 16., Results: Overall, 1084 patients with moderate to severe scalp psoriasis at baseline were included. At week 16, response rates were greater with DEUC versus placebo or apremilast for scalp-specific Physician Global Assessment 0/1 (64.0% vs 17.3% vs 37.7%; P < .0001), ≥90% improvement from baseline in Psoriasis Scalp Severity Index (50.6% vs 10.5% vs 26.1%; P < .0001), and change from baseline in Psoriasis Scalp Severity Index. Responses were maintained through 52 weeks with continuous DEUC. Safety was consistent with the entire study population., Limitations: Lack of data in milder scalp psoriasis., Conclusion: DEUC was significantly more efficacious than placebo or apremilast in improving moderate to severe scalp psoriasis and was well tolerated., Competing Interests: Conflicts of interest Dr Blauvelt has served as a speaker/received honoraria from AbbVie, Eli Lilly and Company, and UCB, served as a scientific adviser/received honoraria from AbbVie, Abcentra, Affibody, Aligos, Almirall, Alumis, Amgen, AnaptysBio, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, EcoR1, Eli Lilly, Escient, Evelo Biosciences, Evommune, Forte Biosciences, Galderma, HighlightII Pharma, Incyte, Janssen, Landos, Leo Pharma, Merck, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, TLL Pharmaceutical, TrialSpark, UCB, Vibliome, and Xencor, and has acted as a clinical study investigator/institution has received clinical study funds from AbbVie, Acelyrin, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, Eli Lilly, Evelo Biosciences, Galderma, Incyte, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Sun Pharma, and UCB. Dr Rich has conducted research as a principal investigator for AbbVie, Arcutis, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Sun Pharma, and UCB. Dr Sofen has served as a clinical investigator for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, Leo Pharma, Novartis, and Sun Pharma. Dr Strober has served as a consultant (with honoraria) for AbbVie, Alumis, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Immunic Therapeutics, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli Lilly, EPI Health, Evelo Biosciences, Janssen, Leo Pharma, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ono Pharmaceutical, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, UNION Therapeutics, Ventyx Biosciences, and vTv Therapeutics; has stock options in Connect Biopharma and Mindera Health; has served as a speaker for AbbVie, Eli Lilly, Incyte, Janssen, Regeneron, and Sanofi Genzyme; served a scientific co-director (with a consulting fee) for CorEvitas Psoriasis Registry; and has served as an investigator for AbbVie, Cara Therapeutics, CorEvitas Psoriasis Registry, Dermavant, Dermira, and Novartis. Dr Merola has served as a consultant and/or investigator for Amgen, AbbVie, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB. Dr Lebwohl has received research funds on behalf of Mount Sinai from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, Janssen, Ortho Dermatologics, Regeneron, and UCB, and has served as a consultant for Aditum Bio, Almirall, AltruBio, AnaptysBio, Arcutis, Arena, Aristea, Arrive Technologies, Avotres, BiomX, Boehringer Ingelheim, Brickell Biotech, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, CorEvitas Psoriasis Registry, Dermavant, Dr Reddy's Laboratories, Evelo Biosciences, Evommune, Forte Biosciences, Helsinn Therapeutics, Hexima, Leo Pharma, Meiji Seika Pharma, Mindera Health, Pfizer, Seanergy, and Verrica. Dr Morita has received honoraria as meeting chair/lecturer from AbbVie, AYUMI Pharmaceutical, Boehringer Ingelheim Japan, Celgene K.K., Eisai, Eli Lilly Japan K.K., Inforward, Janssen Pharmaceutical K.K., Kyowa Kirin, Maruho, Mitsubishi Tanabe Pharma, Nippon Kayaku, Novartis Pharma K.K., Taiho Pharmaceutical, Torii Pharmaceutical, and Ushio; has received funding from AbbVie GK, Eisai, Eli Lilly Japan K.K., Kyowa Hakko Kirin, Leo Pharma KK, Maruho, Mitsubishi Tanabe Pharma, Novartis Pharma K.K., Taiho Pharmaceutical, and Torii Pharmaceutical; and has received consulting fees from AbbVie GK, Boehringer Ingelheim Japan, Bristol Myers Squibb, Celgene K.K., Eli Lilly Japan K.K., GlaxoSmithKline K.K., Janssen Pharmaceutical K.K., Kyowa Kirin, Maruho, Mitsubishi Tanabe Pharma, Nichi-Iko Pharmaceutical, Nippon Kayaku, Novartis Pharma K.K., NPO Health Institute Research of Skin, Pfizer Japan, Sun Pharma, Torii Pharmaceutical, and UCB Japan. Dr Szepietowski has served as an advisory board member/consultant for AbbVie, Leo Pharma, Novartis, Pierre-Fabre, Sanofi Genzyme, and Trevi; has served as a speaker for AbbVie, Eli Lilly, Janssen-Cilag, Leo Pharma, Novartis, and Sanofi Genzyme; and has served as an investigator for AbbVie, Amgen, Bristol Myers Squibb, Galapagos, Galderma, Incyte, InfraRx, Janssen-Cilag, Menlo Therapeutics, Merck, Novartis, Pfizer, Regeneron, Trevi, and UCB. Dr Lambert has received unrestricted grants from AbbVie, Almirall, Celgene, Eli Lilly, Janssen-Cilag, Leo Pharma, Novartis, and UCB; has served as a speaker for AbbVie, Almirall, Bristol Myers Squibb, Janssen-Cilag, Pfizer, and UCB; and has served as a consultant for AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen-Cilag, Leo Pharma, Novartis, and UCB. Ms. Hippeli, Dr Colston, Dr Balagula, and Dr Banerjee are employees of and stockholders in Bristol Myers Squibb. Dr Thaçi has received grant/research support from, served as a consultant for, and served on a scientific advisory board speakers bureau for AbbVie, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, Galderma, Janssen-Cilag, Leo Pharma, New Bridge, Novartis, Pfizer, Regeneron, Roche, Sandoz-Hexal, Sanofi, Target-Solution, and UCB., (Copyright © 2023 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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