Bruce Strober, MD, PhD

New phase 3 trial data indicates that deucravacitinib was superior to apremilast and to placebo for adults patients with moderate-to-severe plaque psoriasis.

The study was developed to further explore the data from the 2 previous POETYK trials, and this one was known as PSO-2.

Results from the previous studies had found that for both plaque psoriasis and psoriatic arthritis, deucravacitinib was substantially more efficacious than placebo. This time, the research team used an active comparator to assess the treatment’s efficacy.

The study was led by Bruce Strober, MD, PhD, from Yale University School of Medicine’s Department of Dermatology.

“This report presents primary results from the phase 3 POETYK psoriasis (PSO)-second (2) trial, which compared the efficacy and safety of deucravacitinib versus placebo and an active comparator, apremilast,” Strober and colleagues wrote. “PSO-2 included a randomized withdrawal and maintenance period to evaluate the durability and maintenance of response with deucravacitinib.”

Research and Methods

The investigators designed PSO-2 to be a placebo-and active comparator-controlled, randomized, multi-center, double-blinded study.

They recruited 1020 adult plaque psoriasis patients aged 18 or older, with inclusion criteria being a static Physician's Global Assessment (sPGA) score of ≥3, a Psoriasis Area and Severity Index (PASI) rating of ≥12, and body surface area involvement of ≥10%) for ≥6 months prior to recruitment.

If the 1020 study participants had previously been given some type of therapy for their psoriasis, they were still recruited provided they had a washout period between then and the study.

During the course of their research—from June 2018 to November 2019—the investigators randomized the patients 2 to 1 to 1, with 6 mg of deucravacitinib or placebo being given every day or 30 mg of apremilast being administered twice per day.

The research team also randomized the participants with a stratification by geographic area (US compared to elsewhere in the world), previous biologic exposure for inflammatory conditions like psoriasis (yes or no), and participant body weight (≥90 kg versus <90 kg).

Study Findings

The study’s results indicated that by week 16 of the POETYK PSO-2 study, their primary endpoint was met and deucravacitinib showed significantly higher percentages for both sPGA scores (49.5% versus 8.6%; P < .0001) and PASI 75 scores (53.0% versus 9.4%; P < .0001) by 16 weeks.

The investigators also noted that participants’ response rates for the listed outcomes went on to increase through to 24 weeks, adding that they were reported as higher for deucravacitinib compared to apremilast at both 16 and 24 weeks.

The research team noted that deucravacitinib was associated with higher PASI 90, PASI 100, and sPGA 0 responses after 16 weeks compared to placebo and to apremilast (P ≤ .0051).

The investigators also added that the drug demonstrated superiority compared to apremilast in PASI 90 scores after 24 weeks (32.5% versus 19.7%; P = .0001) as well. PASI 75 responses were maintained over 52 weeks.

“In POETYK PSO-2, deucravacitinib was superior to placebo and apremilast and provided clinically meaningful improvements over 52 weeks in multiple efficacy measures,” they wrote. “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.”

The study, “Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program for Evaluation of TYK2 inhibitor psoriasis second trial,” was published online in the Journal of the American Academy of Dermatology.