Deucravacitinib superior to placebo, apremilast in plaque psoriasis treatment

Deucravacitinib demonstrated superiority compared with placebo and apremilast in the treatment of adults with moderate to severe plaque psoriasis, according to findings from a phase 3 trial.

“Current therapies for plaque psoriasis, including biologics and small-molecule oral agents, are generally efficacious but physicians often have to choose between efficacy, safety and patient convenience when recommending treatments,” Bruce Strober, MD, PhD, clinical professor of dermatology at Yale University School of Medicine, and colleagues wrote. “Therefore, novel, oral targeted therapies that are more efficacious, well tolerated and convenient to administer are needed.”

This 52-week, double-blinded, phase 3 trial randomly assigned 1,020 patients 2:1:1 to once-daily deucravacitinib 6 mg, twice-daily apremilast 30 mg or placebo. Eligible participants were aged at least 18 years, scored 12 or more on the PASI, maintained a static PGA score of at least 3 and had a body surface area involvement of at least 10% for 6 months or longer. Efficacy outcomes were assessed at baseline and at weeks 1, 2, 3, 4, 8, 12 and 16, followed by every 4 weeks until week 52.

By week 16, a greater proportion of patients on deucravacitinib achieved the coprimary efficacy endpoint of PASI 75 compared with those on placebo (53% vs. 9.4%; P < .0001) or apremilast (53% vs. 39.8%; P = .0004). There was also a greater proportion of patients on deucravacitinib that achieved the other coprimary efficacy endpoint of a static PGA score of 0 or 1 with a 2 point of more improvement from baseline compared with placebo or apremilast (49.5% vs. 8.6% vs. 33.9%; both, P < .0001).

Of the patients who achieved PASI 75 on deucravacitinib, 80.4% maintained that response through week 52.

Overall rates of adverse effects were similar across groups and treatment periods.

“The overall safety profile of deucravacitinib, including a slight increase in the risk of nonserious viral infections, appears to be consistent with the mechanism of selective TYK2 inhibition,” Strober and colleagues wrote. “These findings suggest deucravacitinib has the potential to be an efficacious and well-tolerated, once-daily, oral treatment option for plaque psoriasis.”