Sotyktu Gets FDA Nod as First TYK2 Inhibitor for Psoriatic Arthritis
Key Takeaways
The FDA has approved deucravacitinib (Sotyktu) for adults with active psoriatic arthritis, according to a press release from the manufacturer.
Approval was based on data from the phase 3 POETYK PsA-1 and POETYK PsA-2 trials showing significantly higher ACR20 responses vs placebo at Week 16.
The once-daily oral therapy expands treatment options targeting both joint and skin manifestations of psoriatic disease.
The US Food and Drug Administration (FDA) has approved deucravacitinib (Sotyktu; Bristol Myers Squibb) for the treatment of adults with active psoriatic arthritis (PsA), representing the first oral therapy in its class approved for the treatment of the condition, according to a news release.
Approval was supported by results from the phase 3 POETYK PsA-1 and POETYK PsA-2 randomized clinical trials evaluating deucravacitinib 6 mg once daily in adults with active PsA. In both trials, more patients treated with deucravacitinib achieved the primary endpoint of an American College of Rheumatology 20 (ACR20) response at week 16 compared with placebo.
In POETYK PsA-1, 54% of patients receiving deucravacitinib achieved an ACR20 response vs. 34% with placebo, representing a 20-percentage-point difference (95% CI, 12-27). In POETYK PsA-2, ACR20 responses were observed in 54% of treated patients compared with 39% of those receiving placebo, a 15-percentage-point difference (95% CI, 7-23). Additional endpoints included ACR50 and ACR70 responses, as well as minimal disease activity (MDA), though multiplicity adjustments were not applied to some secondary analyses.
Across both studies, deucravacitinib treatment was also associated with improvements in health-related quality of life, including increases in the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS) score at Week 16 compared with placebo.
The safety profile in patients with PsA was consistent with prior studies in plaque psoriasis. The most common adverse reactions occurring in at least 1% of treated patients and more frequently than placebo included upper respiratory infections, increased creatine phosphokinase levels, herpes simplex, mouth ulcers, folliculitis, and acne.
“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, in the press release. “By aiding in symptom management, [deucravacitinib] could make a meaningful difference for patients.”