Bristol Myers Squibb (NYSE: BMY) announced positive two-year results from the Phase 3 POETYK PsA-2 study, demonstrating durable efficacy and a consistent safety profile for Sotyktu (deucravacitinib) in adults with active psoriatic arthritis. The U.S. Food and Drug Administration approved Sotyktu for this indication in March.
Clinical Efficacy Data
Among patients who entered the open-label extension (OLE), clinical responses improved from Week 16 through Week 52 and were maintained through Week 104. The data covered patients who received Sotyktu continuously from the start of the Phase 3 study and those who switched from placebo to Sotyktu at Week 16. In March 2025, Bristol Myers Squibb revealed pivotal trial data where Sotyktu-treated patients achieved significantly greater ACR20 response compared with placebo at Week 16 (54.2% versus 39.4%).
| Patient Group |
ACR 20 Response |
ACR 50 Response |
ACR 70 Response |
MDA Response |
| Continuous Treatment (Observed) |
76.2% |
52.6% |
34.6% |
51.2% |
| Continuous Treatment (NRI) |
65.3% |
44.9% |
29.4% |
43.7% |
| Placebo-to-Sotyktu Switch (Observed) |
76.9% |
54.6% |
37.7% |
48.7% |
| Placebo-to-Sotyktu Switch (NRI) |
69.3% |
49.2% |
33.9% |
43.7% |
ACR: American College of Rheumatology; MDA: Minimal Disease Activity; NRI: Nonresponder Imputation.
Expert Commentary
Philip Mease, MD, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, Seattle, noted that psoriatic arthritis is a complex, chronic disease requiring treatment options that support symptom control beyond initial months.
"These longer-term results strengthen the evidence supporting Sotyktu as a durable oral option for managing key joint and skin manifestations, with a favorable safety profile," Mease said.
Liz Colston, MD, PhD, vice president and head of Immunology development at Bristol Myers Squibb, stated that the results reinforce the durable efficacy and safety profile observed across the clinical program.
"These positive data add to our understanding of Sotyktu in psoriatic arthritis and reinforce our confidence in its potential role in helping address the needs of people living with chronic rheumatic diseases," Colston said.
Safety Profile
Sotyktu was well-tolerated through Week 104, with no new safety signals identified. The safety outcomes were consistent with previously reported results through 52 weeks and the established five-year psoriasis clinical program.
In patients with any Sotyktu exposure through the two-year cumulative period:
- Adverse events (AEs) occurred in 86.6% of 604 patients.
- Serious AEs occurred in 12.6% of patients.
- AEs leading to discontinuation occurred in 7.6% of patients.
The most common adverse events were upper respiratory tract infection, nasopharyngitis, and COVID-19.
What the Numbers Show
The observed response rates for patients who switched from placebo to Sotyktu at Week 16 were comparable to those who received continuous treatment from the start. Specifically, the ACR 20 response rates were 76.9% for switchers versus 76.2% for continuous users, suggesting that initiating therapy after a placebo period does not significantly diminish long-term clinical outcomes in this cohort.