I'm LongbridgeAI, I can summarize articles.Bristol Myers Squibb reported that Sotyktu maintains durable efficacy and safety over two years in treating active psoriatic arthritis, based on Phase 3 POETYK PsA-2 trial data. Clinical responses improved through Week 52 and remained stable through Week 104. The FDA approved Sotyktu for this indication in March. Adverse events were consistent with previous reports, with no novel safety signals identified.
Bristol Myers Squibb Co. (NYSE:BMY) on Thursday shared long-term results from the Phase 3 POETYK PsA-2 trial and its open-label extension, demonstrating that Sotyktu (deucravacitinib) maintains durable efficacy and a consistent safety profile over two years in adults with active psoriatic arthritis.
Clinical responses among participants improved from Week 16 through Week 52 and remained well-maintained through Week 104 across key metrics, including American College of Rheumatology 20/50/70 and Minimal Disease Activity benchmarks.
In March, the U.S. Food and Drug Administration (FDA) approved Sotyktu for active psoriatic arthritis.
Patient Response Breakdown
Among individuals on continuous Sotyktu treatment through two years, observed ACR 20/50/70 response rates hit 76.2%, 52.6%, and 34.6% at Week 104.
Nonresponder imputation (NRI) analyses yielded corresponding rates of 65.3%, 44.9%, and 29.4%.
Participants switching from placebo to active therapy at Week 16 demonstrated similar long-term progress, achieving observed ACR 20/50/70 response rates of 76.9%, 54.6%, and 37.7%.
In March 2025, Bristol Myers Squibb revealed data from the pivotal Phase 3 POETYK PsA-2 trial.
The trial met its primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving ACR20 response (at least a 20% improvement in signs and symptoms of disease) compared with placebo at Week 16 (54.2% versus 39.4%).
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Safety Profile And Next Steps
MDA response rates reached 51.2% in the continuous group and 48.7% in the placebo crossover cohort based on observed data, with both groups recording 43.7% under NRI analysis.
Sotyktu proved well-tolerated through Week 104, aligning with previously reported 52-week results and long-term psoriasis clinical programs, without generating novel safety signals.
Across 604 patients evaluated over two years, adverse events occurred in 86.6% of participants, serious adverse events affected 12.6%, and 7.6% discontinued therapy due to adverse events.
BMY Price Action: Bristol-Myers Squibb shares were down 0.35% to $63.38 at the time of publication on Thursday, according to Benzinga Pro data.
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