Bristol Myers Squibb’s phase 3 POETYK PsA-2 trial demonstrates superiority of Sotyktu compared with Placebo in patients with psoriatic arthritis

Bristol Myers Squibb announces new positive data from the pivotal Phase 3 POETYK PsA-2 trial evaluating the efficacy and safety of Sotyktu in adults with active psoriatic arthritis. The POETYK PsA-2 trial met its primary endpoint, with a significantly greater proportion of Sotyktu -treated patients achieving ACR20 response compared with placebo at Week 16. The overall safety profile of Sotyktu through 16 weeks of treatment was consistent with that established in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials.

“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.”

Note that in the POETYK PsA-2 trial, no new safety signals were identified. In the placebo, Sotyktu and apremilast arms, adverse events 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. Nonetheless, 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.”

 

---

---

Related Topics and Keywords

Bristol-Myers Squibb, Phase 3 POETYK PsA-2 Trial, psoriatic arthritis, Sotyktu (deucravacitinib)