Deucravacitinib (Sotyktu, Bristol Myers Squibb) showed durable response rates and consistent safety in patients with moderate-to-severe plaque psoriasis after four years of continuous treatment, according to results from the POETYK PSO long-term extension (LTE) trial.
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), Bristol Myers Squibb reports.
The safety profile of deucravacitinib at Year 4 remained consistent with the established safety profile, with no new safety signals identified.
“These four-year results further validate the safety profile, efficacy, and key role of once-daily [deucravacitinib], the first and only TYK2 inhibitor available, for adults with moderate-to-severe plaque psoriasis,” says 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, in a news release. “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 deucravacitinib 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 deucravacitinib 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 deucravacitinib, 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).
“The data from our robust POETYK PSO clinical program continue to reinforce the potential of the first-in-class [deucravacitinib] as an oral standard of care for individuals living with moderate-to-severe plaque psoriasis,” says Alyssa Johnsen, MD, PhD, senior vice president and head of clinical development, Immunology, Cardiovascular and Neuroscience, Bristol Myers Squibb. “Our leadership in TYK2 innovation highlights our transformational science that is advancing care for immune-mediated diseases.”
