FDA Approves Deucravacitinib for Active Psoriatic Arthritis

The U.S. Food and Drug Administration has approved Deucravacitinib (Sotyktu) for the treatment of adults with Psoriatic Arthritis.

This oral drug is a selective TYK2 inhibitor and had previously been approved for adults with Plaque Psoriasis.

“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).

Efficacy Results at Week 16 in Adults with Psoriatic Arthritis (NRIa)

ACR50 and ACR70 were additional endpoints. Additional endpoints were not adjusted for multiplicity; therefore, statistical significance has not been established.

N is number of randomized and treated subjects

• Statistically significant from placebo (p=0.0012)

• Statistically significant from placebo (p=0.0007)

a NRI = Non-Responder Imputation

b Multiplicity-controlled p<0.0002,Sotyktuvs. placebo comparison

c Minimal disease activity (MDA) = 5 out of 7 outcomes: tender joint count<1; swollen joint count<1; Psoriasis Activity and Severity Index<1 or body surface area<3; patient pain visual analogue scale (VAS)<15; patient global disease activity VAS<20; Health Assessment Questionnaire Disability Index<0.5; tender entheseal points<1

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.

Today's approval of Sotyktu in psoriatic arthritis is a tangible demonstration of Bristol Myers Squibb’s commitment to develop medicines that help fill unmet needs in the treatment landscape.