On Mar. 6, 2026, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved Sotyktu^® (deucravacitinib) for the treatment of adults with active psoriatic arthritis (PsA). Sotyktu, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, is the first TYK2 inhibitor to be approved for PsA.

This FDA approval is based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 trials, which evaluated the efficacy and safety of Sotyktu 6 mg once daily in adults with active psoriatic arthritis. In both trials, treatment with Sotyktu resulted in significant improvement in disease activity, as measured by American College of Rheumatology (ACR) 20 (the primary endpoint) and Minimal Disease Activity (MDA) response (key secondary endpoint).

The overall safety profile of Sotyktu observed in individuals with active psoriatic arthritis was generally consistent with the safety profile in those with plaque psoriasis. Most common adverse reactions (≥1% in Sotyktu and greater than placebo) are: upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne. Sotyktu is associated with the following warnings and precautions: hypersensitivity reactions, infections, tuberculosis, malignancy including lymphomas, rhabdomyolysis and elevated CPK, laboratory abnormalities, immunizations, and potential risks related to JAK inhibition.

The FDA first approved Sotyktu in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sotyktu is not recommended for use with other potent immunosuppressants in this population. Since then, multiple global regulatory authorities have approved Sotyktu for that indication. Sotyktu has five years of clinical efficacy and safety data in patients with moderate-to-severe plaque psoriasis.

Psoriatic arthritis (PsA) is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (inflammation where tendon or ligament attaches to the bone), dactylitis (swelling of finger and toe joints) and psoriatic skin and nail lesions. Up to 30 percent of patients with psoriasis go on to develop PsA. In addition to impairments in physical function, pain and fatigue caused by PsA, the disease can significantly impact the well-being of patients. Patients with PsA are also at increased risk of serious comorbidities.