FDA Approves Bristol Myers Squibb’s Sotyktu as First TYK2 Inhibitor for Adults with Psoriatic Arthritis

The U.S. Food and Drug Administration (FDA) has approved Sotyktu (deucravacitinib) for the treatment of adults with active Psoriatic Arthritis (PsA). Developed by Bristol Myers Squibb, Sotyktu is an oral, once-daily therapy and becomes the first selective tyrosine kinase 2 (TYK2) inhibitor approved for psoriatic arthritis.

The approval expands the medicine’s use beyond its initial 2022 FDA approval for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Al Reba, SVP, Cardiovascular & Immunology Commercialization at BMS, said the approval highlights Sotyktu’s role in addressing both skin and joint manifestations of psoriatic disease while supporting continued development in diseases with limited treatment options.

The FDA approval is supported by positive results from the pivotal Phase 3 POETYK PsA-1 (NCT04908202) and POETYK PsA-2 trials (NCT04908189), which evaluated Sotyktu 6 mg once daily in adults with active Psoriatic Arthritis.

Together, the randomized, double-blind, placebo-controlled studies enrolled more than 1,200 patients. POETYK PsA-1 included 670 patients who were biologic disease-modifying antirheumatic drug (bDMARD)-naïve, while POETYK PsA-2 enrolled 624 patients who were either bDMARD-naïve or previously treated with TNF-alpha inhibitors.

Participants met CASPAR diagnostic criteria, had at least three swollen and three tender joints, and either active or documented plaque psoriasis.

In both trials, treatment with Sotyktu resulted in significant improvements in disease activity compared with placebo, with the primary endpoint defined as the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response at Week 16, along with key secondary endpoints including Minimal Disease Activity (MDA) response.

Beyond improvements in joint disease activity, patients treated with Sotyktu also showed improvements in health-related quality of life. In clinical trials, the therapy improved the SF-36 Physical Component Summary score at Week 16 compared with placebo, along with improvements across domains including physical functioning, role limitations due to physical health, bodily pain, and general health.

These outcomes highlight the therapy’s potential impact on both the physical symptoms and daily functioning of patients living with psoriatic arthritis.

Sotyktu is a selective TYK2 inhibitor designed to target immune signaling pathways that drive inflammatory diseases. The drug works by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of the enzyme and downstream modulation of cytokine signaling. This mechanism mediates the activity of interleukin-23, interleukin-12, and type 1 interferons, which are key drivers of inflammation in psoriasis and psoriatic arthritis.

Unlike broader JAK inhibitors, Sotyktu has demonstrated high selectivity for TYK2 and has not been shown to inhibit JAK1, JAK2, or JAK3 in in-vitro studies.

The safety profile observed in the psoriatic arthritis trials was generally consistent with previous studies of Sotyktu in plaque psoriasis. The most common adverse reactions included upper respiratory infections, increased blood creatine phosphokinase levels, herpes simplex infections, mouth ulcers, folliculitis, and acne.

Steven Taylor, President and CEO of the Arthritis Foundation, said the approval introduces an additional oral treatment option for patients living with psoriatic arthritis, a condition characterized by debilitating joint and skin symptoms.

The drug carries warnings and precautions; for detailed safety information including adverse reactions, precautions, warnings, and boxed warnings is available in the official U.S. prescribing information: https://packageinserts.bms.com/pi/pi_sotyktu.pdf.

Psoriatic arthritis is a chronic immune-mediated inflammatory disease characterized by joint inflammation along with skin and nail involvement associated with psoriasis.

The condition can manifest as inflammatory arthritis, enthesitis, dactylitis, and psoriatic skin lesions. Up to 30 percent of patients with psoriasis eventually develop psoriatic arthritis, and the disease can significantly impair physical function while increasing the risk of multiple comorbidities.

The approval of Sotyktu introduces a new oral targeted therapy option that addresses both joint and skin manifestations of psoriatic disease.

Reference

U.S. FDA Approves Bristol Myers Squibb’s Sotyktu® (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis, 06 March 2026, Bristol Myers Squibb – U.S. FDA Approves Bristol Myers Squibb’s Sotyktu® (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs, ClinicalTrials.gov ID NCT04908202, https://clinicaltrials.gov/study/NCT04908202

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment, ClinicalTrials.gov ID NCT04908189, https://clinicaltrials.gov/study/NCT04908189