BMS’ Sotyktu Receives FDA Expansion in Psoriatic Arthritis

Bristol Myers Squibb (BMS) has received expanded FDA approval for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis (PsA). 

The approval marks a major milestone as Sotyktu is now the first and only oral selective tyrosine kinase 2 (TYK2) inhibitor approved for PsA.

Sotyktu, first approved in 2022 for adults with moderate to severe plaque psoriasis, works by selectively inhibiting TYK2, a key enzyme involved in inflammatory signaling. 

The new indication demonstrates its efficacy across the full spectrum of psoriatic disease, addressing both the skin and joint manifestations that affect millions of patients worldwide.

Psoriatic arthritis is a chronic, immune-mediated, heterogeneous disease that can present with inflammatory arthritis, enthesitis (inflammation at tendon or ligament attachment sites), dactylitis (swelling of fingers or toes) and psoriatic skin and nail lesions. Up to 30% of people with psoriasis eventually develop psoriatic arthritis. 

Beyond pain, fatigue and reduced physical function, the disease can significantly affect overall quality of life, and patients with psoriatic arthritis face a higher risk of serious comorbidities.

Trial investigator Philip J. Mease, MD, Director of Rheumatology Research, Swedish Medical Center/Providence S. Joseph Health, and Clinical Professor, University of Washington School of Medicine, told Xtalks that, “The approval of Sotyktu as the first and only TYK2 inhibitor for adults with active psoriatic arthritis adds an important option to the treatment landscape. For rheumatologists, it provides a new oral therapy to consider for long term disease management in patients with both joint and skin involvement, with a well characterized safety profile and no boxed warning.”

“For people living with psoriatic arthritis, having additional oral treatment options can be meaningful, particularly given the chronic and multifaceted nature of the disease. From a rheumatologist’s perspective, the approval of Sotyktu for adults with active psoriatic arthritis provides another option to consider when addressing both joint and skin manifestations of psoriatic arthritis.”

The expanded label for psoriatic arthritis was supported by results from the POETYK PsA-1 and POETYK PsA-2 trials in which treatment with Sotyktu led to significant improvement in disease activity.

In both studies, at Week 16, 54% of patients who received Sotyktu experienced a 20% improvement in disease activity versus 39% on placebo in the PsA-1 trial and 34% on placebo in the PsA-2 trial. 

At the 50% improvement level, 24% and 29% on Sotyktu reached the threshold versus 14% and 16% of those on placebo, in the respective trials.

In 2019, BMS acquired Sotyktu, then still a pipeline asset, in its big-ticket purchase of Celgene. 

Sotyktu sales amounted to $291 million in 2025. With its newly expanded approval and ongoing adoption, the therapy has the potential to achieve blockbuster status, bolstering BMS’ leadership in psoriatic disease and immunology.

The treatment competes with Amgen’s blockbuster Otezla (apremilast), which BMS sold to the company in 2019 over antitrust issues related to the Celgene merger.