Bristol Myers Squibb (NYSE: BMY) presented two-year data from the Phase 3 POETYK PsA-2 study and its open-label extension (OLE) showing sustained efficacy and a consistent safety profile for Sotyktu (deucravacitinib) in adults with active psoriatic arthritis. The data were presented at the Congress of Clinical Rheumatology - West in Huntington Beach, California.

Among patients who received Sotyktu continuously from the start of the Phase 3 study through the OLE, ACR 20/50/70 response rates at Week 104 were 76.2%, 52.6% and 34.6%, respectively, based on observed analysis, and 65.3%, 44.9% and 29.4% using nonresponder imputation. Minimal Disease Activity response rates were 51.2% (observed) and 43.7% (nonresponder imputation).

Among patients who switched from placebo to Sotyktu at Week 16 and continued through the OLE, ACR 20/50/70 response rates at Week 104 were 76.9%, 54.6% and 37.7% (observed) and 69.3%, 49.2% and 33.9% (nonresponder imputation). Minimal Disease Activity response rates were 48.7% (observed) and 43.7% (nonresponder imputation).

Clinical responses continued to improve from Week 16 through Week 52 and were maintained through Week 104 across both patient groups.

In terms of safety, adverse events occurred in 86.6% of 604 patients with any Sotyktu exposure through the two-year period, serious adverse events in 12.6% of patients, and adverse events leading to discontinuation in 7.6% of patients. The most common adverse events were upper respiratory tract infection, nasopharyngitis and COVID-19. No new safety signals were identified.

Philip Mease, MD, director of rheumatology research at Providence Swedish Medical Center, said the 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."

Sotyktu is an oral, selective tyrosine kinase 2 inhibitor approved in the United States for adults with moderate-to-severe plaque psoriasis and active psoriatic arthritis. According to the press release, Bristol Myers Squibb also plans to present OLE data from the POETYK PsA-1 study at a future medical meeting.