Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial - 14/12/22
, Melinda Gooderham, MD b, Richard B. Warren, MD c, Kim A. Papp, MD, PhD d, Bruce Strober, MD, PhD e, Diamant Thaçi, MD f, Akimichi Morita, MD, PhD g, Jacek C. Szepietowski, MD, PhD h, Shinichi Imafuku, MD i, Elizabeth Colston, MD, PhD j, John Throup, PhD j, Sudeep Kundu, PhD j, Steve Schoenfeld, MD j, Misti Linaberry, MPH j, Subhashis Banerjee, MD j, Andrew Blauvelt, MD, MBA kAbstract |
Background |
Effective, well-tolerated oral psoriasis treatments are needed.
Objective |
To compare the efficacy and safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, versus placebo and apremilast in adults with moderate to severe plaque psoriasis.
Methods |
Participants were randomized 2:1:1 to deucravacitinib 6 mg every day (n = 332), placebo (n = 166), or apremilast 30 mg twice a day (n = 168) in the 52-week, double-blinded, phase 3 POETYK PSO-1 trial (NCT03624127). Coprimary end points included response rates for ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment score of 0 or 1 (sPGA 0/1) with deucravacitinib versus placebo at week 16.
Results |
At week 16, response rates were significantly higher with deucravacitinib versus placebo or apremilast for PASI 75 (194 [58.4%] vs 21 [12.7%] vs 59 [35.1%]; P < .0001) and sPGA 0/1 (178 [53.6%] vs 12 [7.2%] vs 54 [32.1%]; P < .0001). Efficacy improved beyond week 16 and was maintained through week 52. Adverse event rates with deucravacitinib were similar to those with placebo and apremilast.
Limitations |
One-year duration, limited racial diversity.
Conclusion |
Deucravacitinib was superior to placebo and apremilast across multiple efficacy end points and was well tolerated in moderate to severe plaque psoriasis.
Le texte complet de cet article est disponible en PDF.Key words : apremilast, clinical trial, deucravacitinib, efficacy, phase 3, psoriasis, Psoriasis Area and Severity Index, safety, skin diseases, static Physician's Global Assessment
Abbreviations used : AEs, IL, PASI 50, PASI 75, PASI 90, PASI 100, PGA-F 0/1, PSSD, PY, QoL, SAEs, sPGA 0/1, ss-PGA 0/1, TYK2
Plan
| Funding sources: This clinical trial was sponsored by Bristol Myers Squibb. |
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| IRB approval status: The study protocol and patient informed consent received appropriate approval before initiation of the study at each site by an institutional review board and/or independent ethics committee. |
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| Reprints not available from the authors. |
Vol 88 - N° 1
P. 29-39 - janvier 2023 Retour au numéro
Article précédent
- Firm advances in sclerodermatous disorders
- Warren R. Heymann
- Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial
- Bruce Strober, Diamant Thaçi, Howard Sofen, Leon Kircik, Kenneth B. Gordon, Peter Foley, Phoebe Rich, Carle Paul, Jerry Bagel, Elizabeth Colston, John Throup, Sudeep Kundu, Chitra Sekaran, Misti Linaberry, Subhashis Banerjee, Kim A. Papp
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