Bristol Myers Squibb has said new two-year data for Sotyktu (deucravacitinib) showed durable efficacy and a consistent safety profile in adults with active psoriatic arthritis, with treatment responses sustained through 104 weeks.

 

The results, from the Phase 3 POETYK PsA-2 open-label extension showed that clinical responses continued to improve from Week 16 through Week 52 and were maintained through Week 104 among patients receiving Sotyktu. Efficacy was observed across key measures, including American College of Rheumatology (ACR) 20, 50 and 70 responses and Minimal Disease Activity (MDA).

 

Among patients who received Sotyktu continuously from the start of the Phase 3 trial, ACR20, ACR50 and ACR70 response rates at Week 104 were 76.2%, 52.6% and 34.6%, respectively, based on observed analysis. Using nonresponder imputation, the rates were 65.3%, 44.9% and 29.4%.

 

MDA response rates in the same group were 51.2% based on observed analysis and 43.7% using nonresponder imputation.

 

Patients who switched from placebo to Sotyktu at Week 16 also maintained strong responses through two years. At Week 104, ACR20, ACR50 and ACR70 response rates were 76.9%, 54.6% and 37.7% under observed analysis, compared with 69.3%, 49.2% and 33.9% using nonresponder imputation. MDA responses were 48.7% and 43.7%, respectively.

 

“Psoriatic arthritis is a complex, chronic and often debilitating disease that can affect any part of the body, leaving patients in need of treatment options that can support symptom control beyond the initial months of therapy,” said Philip Mease, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, Seattle. 

 

"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.”

 

The company said the treatment remained well tolerated through Week 104, with no new safety signals identified. The safety findings were consistent with results previously reported through 52 weeks and with the long-term safety profile observed in Sotyktu's five-year psoriasis clinical program.

 

Among 604 patients with any Sotyktu exposure during the two-year cumulative period, adverse events were reported in 86.6%, serious adverse events in 12.6% and adverse events leading to treatment discontinuation in 7.6%. The most common adverse events were upper respiratory tract infection, nasopharyngitis and COVID-19.

 

“Following the approval of Sotyktu for adults with active psoriatic arthritis earlier this year, these results through two years of treatment in POETYK PsA-2 reinforce the durable efficacy and safety profile observed across our clinical program and the various subgroups assessed,” said Liz Colston, vice president and head of Immunology development, Bristol Myers Squibb. 

 

“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.”

 

POETYK PsA-2 enrolled 729 adults with active psoriatic arthritis, including patients who had not previously received biologic disease-modifying antirheumatic drugs and patients who had previously received TNF-alpha inhibitor treatment.

 

Of the 729 randomized participants, 312 were assigned to continuous Sotyktu treatment, 312 to placebo followed by Sotyktu, and 105 to an apremilast-to-Sotyktu sequence. A total of 245, 254 and 70 patients, respectively, entered the optional open-label extension.

 

The Phase 3 program includes two trials, POETYK PsA-1 and POETYK PsA-2, evaluating Sotyktu in adults with active psoriatic arthritis. Patients completing 52 weeks could potentially enter open-label extensions and receive Sotyktu 6 mg once daily through Week 156.

 

Sotyktu is an oral selective tyrosine kinase 2 (TYK2) inhibitor approved in the United States and other countries for adults with moderate-to-severe plaque psoriasis and active psoriatic arthritis.