Deucravacitinib Approved for Adults With Moderate to Severe Plaque Psoriasis

Last week, the US Food and Drug Administration announced approval of deucravacitinib as an oral treatment for adults with moderate to severe plaque psoriasis.

Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor indicated for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. This approval makes deucravacitinib the first oral treatment approved in 10 years, and the first orally dosed, once-daily treatment for moderate to severe plaque psoriasis.

This approval was granted based on the results of the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials of once-daily deucravacitinib compared with placebo and twice-daily apremilast in 1684 patients aged 18 years and older with moderate to severe plaque psoriasis. These data showed that, when compared with placebo and apremilast, deucravacitinib demonstrated superior efficacy at both 16 and 24 weeks, and responses persisted through 52 weeks.

Deucravacitinib is not recommended for use in combination with other potent immunosuppressants, and its common adverse reactions include upper respiratory infections, blood creatine phosphokinase increase, herpes simplex, mouth ulcers, folliculitis, and acne.

Reference
U.S. Food and Drug Administration approves Sotyktu (deucravacitinib), oral treatment for adults with moderate-to-severe plaque psoriasis. News release. Bristol Myers Squibb. September 9, 2022. Accessed September 12, 2022. https://news.bms.com/news/corporate-financial/2022/U.S.-Food-and-Drug-Administration-Approves-Sotyktu-deucravacitinib-Oral-Treatment-for-Adults-with-Moderate-to-Severe-Plaque-Psoriasis/default.aspx