Sotyktu Outperforms Placebo in Psoriatic Arthritis Trial

The overall safety profile of Sotyktu through 16 weeks of treatment was consistent with that established in a Phase II PsA clinical trial and Phase III moderate-to-severe plaque psoriasis clinical trials. The new data, which represent the first disclosure of data for the Phase III POETYK trials in PsA, were presented as a late-breaking abstract (#66894) at the American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

“Given the complex, multifaceted and heterogenous nature of psoriatic arthritis, there continues to be a significant need for safe and effective oral treatments,” said Philip Mease, MD, director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and clinical professor at the University of Washington School of Medicine, Seattle. “These results are particularly encouraging because they support the potential for Sotyktu to impact both joint and skin symptoms, as well as patient-reported quality of life outcomes. Combined with a well-tolerated safety profile, these data show Sotyktu may serve as an important new treatment option for these patients.”

Additionally, treatment with Sotyktu met important secondary endpoints across PsA disease activity at Week 16, demonstrating improvement across clinical signs and symptoms, extra-articular manifestations and patient-reported outcomes. Significantly more Sotyktu -treated patients achieved a Psoriasis Area and Severity Index (PASI) 75 response compared with placebo. Treatment with Sotyktu also resulted in significantly greater improvements from baseline in the patient-reported Health Assessment Questionnaire-Disability Index (HAQ-DI) compared with placebo (−0.32 versus −0.21, respectively; p=0.0013). In the POETYK PsA-2 trial, no new safety signals were identified. In the placebo, Sotyktu and apremilast arms, adverse events (AEs) were reported in 54.7%, 62.8% and 73.3% of patients, respectively, and serious AEs in 1.0%, 1.9% and 3.8%, respectively. AEs led to discontinuation in 1.3%, 2.2% and 10.5% in the placebo, Sotyktu and apremilast arms, respectively. Apremilast was included as a safety reference arm in the PsA-2 trial with no formal statistical comparisons planned for efficacy.

“These promising new data demonstrate the potential of Sotyktu as an oral therapy and the first TYK2 inhibitor that may be able to address significant unmet needs of patients living with psoriatic arthritis,” said Edgar Charles, MD, vice president and senior global program lead, Early & Late Development Immunology, Bristol Myers Squibb. “Furthermore, these results support our belief in the capability of Sotyktu in rheumatic conditions and reflect our ongoing commitment to developing medicines for people living with immune-mediated diseases.”

Bristol Myers Squibb will work with key investigators to present additional data from the Phase III POETYK PsA program at upcoming medical congresses this year and looks forward to discussing these results with health authorities.

About the Sotyktu Phase III Psoriatic Arthritis Trial Program: The Phase III Sotyktu psoriatic arthritis (PsA) program includes two Phase III, multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety in adults 18 years of age and older with active PsA: POETYK PsA-1 (IM011-054; NCT04908202 ) and POETYK PsA-2 (IM011-055; NCT04908189). POETYK PsA-1 enrolled approximately 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD naïve). POETYK PsA-2 enrolled approximately 730 patients with active PsA who were bDMARD naïve or had previously received TNFα inhibitor treatment. Both trials include a 52-week treatment period comprised of a placebo-controlled treatment period through Week 16, followed by a reallocation and continued active treatment period from Week 16 to Week 52. POETYK PsA-2 also included an apremilast safety reference arm. The primary endpoint of both trials was the proportion of participants achieving an ACR20 response at Week 16. Important secondary endpoints were also assessed at Week 16 across measures of PsA disease activity. Patients in both trials completing 52 weeks of treatment are potentially eligible to enroll in the open-label extension study.