Abstract
Introduction: Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. This analysis was designed to evaluate the effect of deucravacitinib on additional clinical and quality-of-life (QoL) outcomes and assess the relationship between these outcomes in adults with psoriasis. Methods: Post-hoc analysis of a 12-week Phase 2 trial was conducted for the three most efficacious dosage groups (3 mg twice daily, 6 mg twice daily, 12 mg once daily) and placebo. Investigator assessments for efficacy included Psoriasis Area and Severity Index (PASI), body surface area (BSA) involvement, and static Physician's Global Assessment; QoL was assessed using the Dermatology Life Quality Index (DLQI). Treatment responses and their associations were evaluated over time. Results: Deucravacitinib elicited improvement versus placebo as early as Week 4 for most efficacy measures (including changes in absolute PASI and BSA), with efficacy trends observed from Week 2 to Week 12. Improvements in QoL, assessed by achievement of a DLQI overall score of 0/1 (no effect at all on patient’s life), followed a pattern similar to deucravacitinib-related clinical outcomes over 12 weeks. Overall, patients with greater improvements in psoriasis-related clinical signs and symptoms also reported greater improvement in QoL. However, complete skin clearance was not required for achieving DLQI 0/1. Conclusion: Deucravacitinib treatment produced early response and similar trends in improvements across multiple efficacy assessments and QoL in moderate to severe plaque psoriasis. Deucravacitinib has the potential to become a promising new oral therapy for this condition. Trial Registration: ClinicalTrials.gov identifier; NCT02931838.
| Original language | English |
|---|---|
| Journal | Dermatology and therapy |
| Volume | 12 |
| Issue number | 2 |
| Pages (from-to) | 495-510 |
| Number of pages | 16 |
| ISSN | 2193-8210 |
| DOIs | |
| Publication status | Published - 02.2022 |
Funding
Diamant Thaçi has received honoraria and lecture fees from AbbVie, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Leo Pharma, Novartis, Pfizer, Roche-Posay, Sandoz-Hexal, Sanofi, Target-Solution, and UCB. Bruce Strober has received honoraria from AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli Lilly, Equillium, GlaxoSmithKline, Immunic Therapeutics, Janssen, Leo Pharma, Maruho, Meiji Seika Pharma, Mindera, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB; has served as an investigator for AbbVie, Cara, CorEvitas’ (Corrona) Psoriasis Registry, Dermavant, Dermira, and Novartis; has served as a scientific director (consultant fee) for CorEvitas’ (Corrona) Psoriasis Registry; and has served as a speaker for AbbVie, Amgen, Eli Lilly, Janssen, and Sanofi Genzyme. Kenneth B. Gordon has served as a consultant for AbbVie, Amgen, Almirall, Arcutis, Arena Pharma, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, Incyte, Janssen, Kyowa Hakko Kirin, Leo Pharma, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, and UCB, and has received research grants from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, and UCB. Peter Foley has received grant support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Sanofi, and Sun Pharma; has served as an investigator for AbbVie, Amgen, AstraZeneca, Arcutis, Aslan, Bristol Myers Squibb, Boehringer Ingelheim, Botanix, Celgene, Celtaxsys, CSL, Cutanea, Dermira, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Hexima, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi, Sun Pharma, UCB, and Valeant; has served as an advisory board member for AbbVie, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Galderma, GlaxoSmithKline, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Sanofi, Sun Pharma, UCB, and Valeant; has served as a consultant for Bristol Myers Squibb, Eli Lilly, Galderma, Janssen, Leo Pharma, Novartis, Pfizer, Roche, and UCB; has received travel grants from AbbVie, Eli Lilly, Galderma, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Roche, Sun Pharma, and Sanofi; and has served as a speaker for or received honoraria from AbbVie, Celgene, Eli Lilly, Galderma, GlaxoSmithKline, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Roche, and Valeant. Melinda Gooderham has served as an advisory board member for AbbVie, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galderma, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB; has served as a consultant for AbbVie, Akros, Amgen, Arcutis, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, Kyowa Kirin, Leo Pharma, Novartis, Pfizer, Sanofi Genzyme, and UCB; has served as an investigator for AbbVie, Akros, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermira, Dermavant, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Janssen, Kyowa Kirin, Leo Pharma, Merck, MedImmune, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Takeda, and UCB; and has served on a speakers bureau for AbbVie, Amgen, Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, and UCB. Akimichi Morita has received honoraria from AbbVie GK, 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 research support for 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 served as a consultant for 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 Pharmaceutical Industries, Torii Pharmaceutical, and UCB Japan. Kim A. Papp has served as a consultant for AbbVie, Akros, Amgen, Arcutis, Astellas, AstraZeneca, Baxalta, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, CanFite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Forward Pharma, Galderma, Genentech, Janssen, Kyowa Hakko Kirin, Leo Pharma, Meiji Seika Pharma, Merck Sharp & Dohme, Merck Serono, Mitsubishi Pharma, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Takeda, UCB, and Valent; has received honoraria from AbbVie, Akros, Amgen, Baxter, Boehringer Ingelheim, Celgene, Coherus, Eli Lilly, Forward Pharma, Galderma, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, Merck Sharp & Dohme, Merck Serono, Novartis, Pfizer, Takeda, UCB, and Valeant; has received research grants from AbbVie, Akros, Allergan, Amgen, Anacor, Arcutis, AstraZeneca, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, Leo Pharma, MedImmune, Meiji Seika Pharma, Merck Serono, Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis/Genzyme, Takeda, UCB, and Valeant; has served on a scientific officer/steering committee/advisory board for AbbVie, Akros, Amgen, Anacor, Astellas, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dow Pharma, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Merck Sharp & Dohme, Merck Serono, Novartis, Pfizer, Regeneron, Sanofi Genzyme, and Valeant; and has served on the speakers bureau for AbbVie, Amgen, Astellas, Celgene, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin, Leo Pharma, Merck Sharp & Dohme, Novartis, Pfizer, and Valeant. Lluís Puig has received honoraria or consultation fees from AbbVie, Almirall, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Celgene, Eli Lilly, Fresenius Kabi, Gebro, Janssen, Leo Pharma, Merck-Serono, Merck Sharp & Dohme, Mylan, Novartis, Pfizer, Regeneron, Roche, Samsung Bioepis, Sandoz, Sanofi, and UCB; has received research grants from or participated in clinical trials (paid to institution) for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB; and has served on the speakers bureau for Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, and Pfizer. M. Alan Menter has served on the advisory board for Abbott Labs, Amgen, Boehringer Ingelheim, Janssen Biotech, and Leo Pharma; has served as a consultant for AbbVie, Amgen, Eli Lilly, Janssen Biotech, Leo Pharma, Novartis, Sun Pharma, and UCB; has received honoraria from AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Janssen Biotech, Leo Pharma, Novartis, Sun Pharma, and UCB; has served as an investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen Biotech, Leo Pharma, Merck, Novartis, Sun Pharma, and UCB; has received research grants from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Janssen Biotech, Leo Pharma, Merck, and Sun Pharma; and has served as a speaker for AbbVie, Amgen, Janssen Biotech, Leo Pharma, Sun Pharma, and UCB. Matthew J. Colombo, Yedid Elbez, Renata M. Kisa, June Ye, Andrew A. Napoli, Lan Wei, and Subhashis Banerjee are employees of and shareholders in Bristol Myers Squibb. Joseph F. Merola has served as a consultant and/or investigator for AbbVie, Amgen, Biogen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB. Alice B. Gottlieb has received consultation fees from AnaptysBio, Avotres, Boehringer Ingelheim, Incyte, Lilly ICOS, Novartis, Pfizer, and Sun Pharma; has served on an advisory board for Amgen, Bristol Myers Squibb, Celgene, Janssen, Janssen-Ortho, Leo Pharma, Novartis, and UCB; and has served as an investigator for Janssen-Ortho, Boehringer Ingelheim, Incyte, Novartis, Sun Pharma, UCB, and XBiotech. This analysis was sponsored by Bristol Myers Squibb. Bristol Myers Squibb also funded the journal’s Rapid Service Fees. Professional medical writing from Barbara Zeman, PhD, and editorial assistance were provided by Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, and were funded by Bristol Myers Squibb.
Research Areas and Centers
- Academic Focus: Center for Infection and Inflammation Research (ZIEL)
- Centers: Center for Research on Inflammation of the Skin (CRIS)
DFG Research Classification Scheme
- 2.22-19 Dermatology
