Bristol Myers Squibb’s (BMY) Sotyktu has been approved by the US FDA to treat adults with active psoriatic arthritis (PsA).
The approval is based on positive results from two phase 3 trials (POETYK PsA-1 and POETYK PsA-2), both showing that the drug improves disease activity.
Al Reba, senior vice president, Cardiovascular & Immunology Commercialization, Bristol Myers Squibb, said: “This latest approval of Sotyktu confirms its important role in managing both skin and joint symptoms of psoriatic disease and is a key milestone as we continue to explore its development in diseases that have limited or no treatment options.”
Sotyktu, a once-daily oral drug, is a selective tyrosine kinase 2 (TYK2) inhibitor that was approved by the US FDA in 2022 to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
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.
Philip Mease, director of rheumatology research, Providence Swedish Medical Center, and clinical professor, University of Washington School of Medicine, said: “Psoriatic arthritis is a chronic, progressive autoimmune condition that often involves both the joints and skin, [and] new oral, effective first-line treatments are needed
“Patients often have trouble moving and staying active and can experience pain in the joints, and tendons, or ligaments.
“In clinical trials, health-related quality of life was assessed by the 36-Item Short Form Health Survey (SF-36). Patients treated with Sotyktu showed improvements in SF-36 Physical Component Summary (PCS) score at Week 16 compared to placebo (key secondary endpoint). There were also improvements in all four SF-36 PCS domain scale scores: physical functioning, role-physical, bodily-pain and general health.
“By aiding in symptom management, Sotyktu could make a meaningful difference for patients.”