FDA approves Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis – BMS

Bristol Myers Squibb announced that the 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.

“Today’s announcement marks the introduction of a new, differentiated option to treat adults with active psoriatic arthritis,” said Al Reba, senior vice president, Cardiovascular & Immunology Commercialization, Bristol Myers Squibb. “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.”

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.

“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,” said Philip J. Mease, MD, director of rheumatology research, Providence Swedish Medical Center, and clinical professor, University of Washington School of Medicine. “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.”

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

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.

About the Sotyktu Phase III Psoriatic Arthritis Trial Program
The Phase III Sotyktu PsA program includes two Phase III, multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety of Sotyktu in adults 18 years of age and older with active PsA: POETYK PsA-1 (IM011-054; NCT04908202) and POETYK PsA-2 (IM011-055; NCT04908189).

POETYK PsA-1 included 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD naïve). POETYK PsA-2 included 624 patients with active PsA who were bDMARD naïve or had previously received TNFα inhibitor treatment. Patients met the CASPAR criteria for PsA, with at least 3 swollen and 3 tender joints and had an active or documented history of plaque psoriasis. Both trials include a 52-week treatment period comprised of a placebo-controlled treatment period through Week 16, followed by a reallocation and continued active treatment period from Week 16 to Week 52. POETYK PsA-2 also included an apremilast safety reference arm.

The primary endpoint of both trials was the proportion of participants achieving an ACR20 response at Week 16. Key secondary endpoints were also assessed at Week 16 across measures of PsA disease activity. Patients in both trials completing 52 weeks of treatment were potentially eligible to enroll in open-label extensions through 156 weeks.