New Four-Year Sotyktu (deucravacitinib) Data Demonstrate Durable Response Rates and Consistent Safety in Moderate-to-Severe Plaque Psoriasis

Bristol Myers Squibb (NYSE:BMY) today announced new four-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. After four years of continuous treatment, Week 208 responses for Psoriasis Area and Severity Index (PASI) 75 and 90 were 71.7% and 47.5%, respectively, and 57.2% for static Physician’s Global Assessment (sPGA) 0/1 (clear/almost clear), using modified nonresponder imputation (mNRI). The safety profile of Sotyktu at Year 4 remained consistent with the established safety profile, with no new safety signals identified.

These data were presented at the European Academy of Dermatology and Venereology (EADV) Spring Symposium in St. Julian’s, Malta taking place May 16-18, 2024.

“These four-year results further validate the safety profile, efficacy and key role of once-daily Sotyktu, the first and only TYK2 inhibitor available, for adults with moderate-to-severe plaque psoriasis,” said April Armstrong, MD, MPH, clinical investigator in the POETYK PSO clinical trial program and professor and chief of dermatology at the University of California, Los Angeles. “Many patients and their healthcare providers are looking for an efficacious, convenient oral treatment option that provides sustained relief from this chronic disease, allowing patients to prioritize other aspects of their daily lives. These findings further reinforce that we are able to offer a potential oral standard of care to meet patients’ needs.”

The efficacy analysis included 513 patients who received continuous Sotyktu treatment from Day 1 in the pivotal POETYK PSO-1 and POETYK PSO-2 trials and transitioned to the POETYK PSO-LTE trial. Clinical efficacy outcomes were maintained in patients who were continuously treated with Sotyktu from baseline through Year 4, with sustained response rates for PASI 75 of 71.7% at Year 4 (Year 1, 72.0%; Year 3, 73.8%), PASI 90 of 47.5% (Year 1, 45.6%; Year 3, 49.0%) and sPGA 0/1 of 57.2% (Year 1, 57.7%; Year 3, 55.2%).  

The safety analysis included 1,519 patients who received at least one dose of Sotyktu across POETYK PSO-1, POETYK PSO-2 and POETYK PSO-LTE. Cumulative exposure from parent trial randomization was 4,392.8 patient-years (PYs) for the safety analyses. With increased exposure to Sotyktu, the exposure-adjusted incidence rates (EAIRs)/100 PYs at Year 4 decreased or remained the same as those at Year 1 for adverse events (AEs) (Year 1, 229.2; Year 4, 131.7), serious AEs (Year 1, 5.7; Year 4, 5.0), discontinuation due to AEs (Year 1, 4.4; Year 4, 2.2), herpes zoster (Year 1, 0.8; Year 4, 0.6), malignancies (Year 1, 1.0; Year 4, 0.9), major adverse cardiovascular events (Year 1, 0.3; Year 4, 0.3), venous thromboembolism (Year 1, 0.2; Year 4, 0.1) and deaths (Year 1, 0.2; Year 4, 0.3). EAIRs/100 PYs were calculated as the number of patients with an AE over the total exposure time for all patients at risk (time to an initial AE occurrence for patients with an AE and time of total exposure for patients without an AE).