Bristol Myers Squibb's Sotyktu Shows Results in Psoriatic Arthritis Trials
Bristol Myers Squibb's Sotyktu Shows Results in Psoriatic Arthritis Trials
Bristol Myers Squibb (NYSE:BMY) today announced results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal Phase 3 trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). Both trials met their primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo.
百時美施貴寶(紐約證券交易所代碼:BMY)今天公佈了PoeTyk psa-1(IM011-054)和PoeTyk psa-2(IM011-055)的結果,這兩項關鍵的3期試驗評估了Sotyktu(deucravacitinib)對成人活動性銀屑病關節炎(psA)的療效和安全性。兩項試驗都達到了主要終點,與安慰劑相比,接受Sotyktu治療的患者在治療16周後達到 ACR20 反應(至少改善了20%的疾病體徵和症狀)的比例要高得多。
Additionally, the POETYK PsA-1 and POETYK PsA-2 trials met important secondary endpoints across PsA disease activity at Week 16. The overall safety profile of Sotyktu through 16 weeks of treatment in the POETYK PsA-1 and POETYK PsA-2 trials was consistent with the established safety profile of Sotyktu observed in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials.
此外,PoeTyk pSA-1和PoeTyk PSA-2試驗在第16周達到了psA疾病活動的重要次要終點。在PoeTyk PSA-1和PoeTyk PSA-2試驗中,經過16周的治療,Sotyktu的總體安全性狀況與Sotyktu在2期psA臨牀試驗和3期中至重度斑塊狀銀屑病臨牀試驗中觀察到的Sotyktu的既定安全性狀況一致。