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（紐交所：BMY）今天公佈了POETYk PsA-1（IM011-054）和POETYk PsA-2（IM011-055）的結果，這兩項關鍵的三期臨牀試驗評估了Sotyktu（deucravacitinib）在活躍型銀屑病關節炎（PsA）成人中的療效和安全性。兩項試驗均達到了主要終點，Sotyktu治療的患者在16周治療後，獲得ACR20反應（病證跡象和症狀至少改善20%）的比例明顯高於安慰劑組。
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周達到了銀屑病關節炎疾病活動的重要次要終點。Sotyktu在POETYk PsA-1和POETYk PsA-2試驗中的整體安全性檔案在16周的治療過程中與在一項二期銀屑病關節炎臨牀試驗和三期中度至重度斑塊型銀屑病臨牀試驗中觀察到的已建立的安全性檔案一致。
譯文內容由第三人軟體翻譯。