The US Food and Drug Administration has approved Sotyktu (deucravacitinib) for the treatment of adults with active Psoriatic Arthritis, giving patients a new oral therapy and marking the first approval of a Tyrosine Kinase 2 (TYK2) inhibition treatment for the disease.

 

Developed by Bristol Myers Squibb, the drug is a selective TYK2 inhibitor designed to target key inflammatory pathways involved in psoriatic disease affecting both skin and joints.

 

“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.”

 

The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials, which evaluated Sotyktu 6 mg once daily in adults with active psoriatic arthritis.

 

Across both studies, the treatment met its primary endpoint, demonstrating significant improvement in disease activity compared with placebo. At Week 16, 54% of patients receiving Sotyktu achieved an ACR20 response, compared with 34% and 39% in the placebo groups of PsA-1 and PsA-2 respectively. Patients also showed improvements in ACR50, ACR70, and Minimal Disease Activity responses.

 

The trials enrolled more than 1,200 patients with active psoriatic arthritis. Participants had at least three swollen and three tender joints and either active or documented plaque psoriasis. Both studies included a 16-week placebo-controlled period followed by continued treatment through 52 weeks.

 

The safety profile observed in psoriatic arthritis was consistent with that seen in patients treated for Plaque Psoriasis, for which Sotyktu was first approved by the FDA in 2022.

 

The most common adverse reactions included upper respiratory infections, increased creatine phosphokinase, herpes simplex, mouth ulcers, folliculitis and acne. The drug carries warnings for hypersensitivity reactions, infections including tuberculosis, malignancies such as lymphomas, rhabdomyolysis and laboratory abnormalities, among others.

 

Experts say new oral options are needed.

 

“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, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the 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.”

 

Patient advocacy groups also welcomed the approval.

 

“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.”