FDA Approves First-in-Class Therapy for Psoriasis

The FDA has approved Sotyktu (deucravacitinib) to treat adults with moderate-to-severe plaque psoriasis. Developed by Bristol Myers Squibb, Sotyktu is an oral, allosteric tyrosine kinase 2 (TYK2) inhibitor. This is the first approval worldwide of a TYK2 inhibitor.

April Armstrong, M.D.

“Sotyktu has the potential to become the new standard of care oral treatment for people with moderate-to-severe plaque psoriasis, given its profile in helping patients achieve clearer skin as demonstrated in the POETYK PSO clinical program,” April Armstrong, M.D., MPH, clinical investigator in the POETYK PSO-1 trial and associate dean and professor of Dermatology at the University of Southern California, said in a press release. “People living with moderate-to-severe plaque psoriasis face significant burdens, and Sotyktu is a welcome first-line systemic treatment option.”

The approval is based on results from the pivotal phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials. The trials demonstrated superior efficacy of once-daily Sotyktu compared with placebo and twice-daily Amgen’s Otezla (apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis. Responses with Sotyktu persisted through 52 weeks.

The most common adverse reactions were upper respiratory infections, blood creatine phosphokinase increase, herpes simplex, mouth ulcers and acne. In addition, 2.4% of patients on Sotyktu, 3.8% of patients on placebo, and 5.2% of patients on Otezla experienced adverse reactions leading to discontinuation.

Data from patients in the pivotal POETYK PSO-1 trial who transitioned into the long-term extension trial were presented at the 2022 European Academy of Dermatology and Venereology Congress. At 112 weeks of Sotyktu treatment, modified non-responder imputation (mNRI) response rates were 82.4% for Psoriasis Area and Severity Index (PASI) 75, 55.2% for PASI 90 and 66.5% for static Physician's Global Assessment (sPGA) 0/1.

“These new long-term results showing durable efficacy through up to two years of continuous treatment further support the use of once-daily Sotyktu for people with moderate-to-severe plaque psoriasis and address the need for more effective oral treatment options,” Mark Lebwohl, M.D., dean of Clinical Therapeutics at the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine, Mount Sinai, said in a press release.

Psoriasis is a chronic, systemic immune-mediated disease that affects about 7.5 million people in the United States. Up to 90% of patients with psoriasis have plaque psoriasis, which is characterized by distinct, round or oval plaques typically covered by silvery white scales. Nearly one-quarter of people with psoriasis have cases that are considered moderate-to-severe.