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DOI 10.1080/09546634.2024.2371045

Медицинская библиотека · The Journal of dermatological treatment · 2024

Deucravacitinib onset of action and maintenance of response in phase 3 plaque psoriasis trials.

Korman Neil J, Warren Richard B, Bagel Jerry, Armstrong April W, Gooderham Melinda, Strober Bruce, Thaçi Diamant, Morita Akimichi, Imafuku Shinichi, Foley Peter, Sofen Howard, Zheng Min, Hippeli Lauren, Kisa Renata M, Banerjee Subhashis, Blauvelt Andrew

СтатьяКлиническое исследование III фазыРандомизированное исследованиеПеревод в очереди

Аннотация

AIM: In the global phase 3 POETYK PSO-1 and PSO-2 trials, significantly greater proportions of deucravacitinib-treated patients met the coprimary endpoints (PASI 75, sPGA 0/1) at Week 16 versus placebo or apremilast-treated patients. This analysis evaluated onset of action and maintenance of response in patients randomized to deucravacitinib and placebo only.

METHODS

Adults with moderate to severe plaque psoriasis at baseline were randomized 1:2:1 to oral placebo, deucravacitinib, or apremilast. Onset of action was determined through changes from baseline in mean PASI, BSA, BSA × sPGA, and DLQI. Maintenance of response was assessed using PASI 75, PASI 90, PASI 100, sPGA 0/1, and sPGA 0 response rates through Week 52 in patients who were treated continuously with deucravacitinib, crossed over from placebo to deucravacitinib at Week 16, or received deucravacitinib and achieved PASI 75 by Week 24.

RESULTS

Deucravacitinib showed significantly higher increases in mean percent change from baseline in PASI versus placebo by Week 1. Significant improvement versus placebo was observed in all other efficacy measures by Week 8. Efficacy with deucravacitinib was maintained through Week 52.

CONCLUSION

Deucravacitinib displayed efficacy as early as 1 week and clinical responses were maintained over 52 weeks in patients with moderate to severe plaque psoriasis.

Для цитирования: Korman Neil J, Warren Richard B, Bagel Jerry, Armstrong April W, Gooderham Melinda, Strober Bruce, Thaçi Diamant, Morita Akimichi, Imafuku Shinichi, Foley Peter, Sofen Howard, Zheng Min, Hippeli Lauren, Kisa Renata M, Banerjee Subhashis, Blauvelt Andrew. Deucravacitinib onset of action and maintenance of response in phase 3 plaque psoriasis trials.. The Journal of dermatological treatment. 2024. DOI: 10.1080/09546634.2024.2371045.

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