The US Food and Drug Administration (FDA) has approved Sotyktu (deucravacitinib) by Bristol Myers Squibb 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.

 “Today’s announcement marks the introduction of a new, differentiated option to treat adults with active psoriatic arthritis. 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,” said Al Reba, Senior Vice President, Cardiovascular and Immunology Commercialisation, Bristol Myers Squibb.

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 per cent 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, immunisations and potential risks related to JAK inhibition.

“Psoriatic arthritis is a chronic, progressive autoimmune condition that often involves both the joints and skin. Patients often have trouble moving and staying active and can experience pain in the joints, and tendons, or ligaments. New oral, effective first-line treatments are needed. 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,” said Philip J Mease, MD, Director – Rheumatology Research, Providence Swedish Medical Centre and clinical professor, University of Washington School of Medicine.

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.

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