The U.S. FDA has approved Bristol Myers Squibb (BMS)’ Sotyktu (deucravacitinib) for treatment of adults with active psoriatic arthritis (PsA). Sotyktu is an oral, selective tyrosine kinase 2 (TYK2) inhibitor. According to BMS, Sotyktu is the first TYK2 inhibitor to be approved for PsA.

PsA Defined and How Sotyktu Helps

PsA can best be defined as a chronic, immune-mediated, heterogeneous disease that can have multiple musculoskeletal or skin manifestations. Among these symptoms may be inflammatory arthritis, dactylitis, enthesitis, or psoriatic skin and nail lesions.

Prior to its approval for PsA, Sotyktu gained its first green light from the FDA in 2022. Then, the approved indication was for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Consequently, BMS said up to 30% of patients with psoriasis may go on to develop PsA. And not only can PsA impair physical function and cause pain or fatigue, but also, patients have increased comorbidity risk.

The FDA’s approval for the PsA indication was based on positive results from two pivotal trials (POETYK PsA-1, POETYK PsA-2). In both trials, adults given a once-daily, 6 mg dose of Sotyktu significantly improved their disease activity.

BMS, Others React to FDA Approval

Al Reba, BMS senior vice president, Cardiovascular & Immunology Commercialization, said the latest approval introduces “a new, differentiated option.” Additionally, he called it a key milestone as BMS explores “development in diseases that have limited or no treatment options.”

“New oral, effective first-line treatments [for PsA] are needed,” said Philip J. Mease, MD, in a BMS press release. Mease is director of rheumatology research, Providence Swedish Medical Center, and clinical professor, University of Washington School of Medicine.

“We welcome this new treatment option for people [with PsA],” said Steven Taylor, President and CEO of the Arthritis Foundation. “The psoriatic disease community has been waiting for an additional oral treatment to address the debilitating joint and skin symptoms.”