Deucravacitinib Superior to Apremilast in Patient-Reported Outcomes for Psoriasis

April W. Armstrong, MD, MPH

Credit: Armstrong Research

Deucravacitinib treatment leads to meaningful improvements in patient-reported outcomes among individuals with moderate-to-severe plaque psoriasis versus apremilast and placebo, according to recent findings.¹

These data represented the conclusion of new research led by April W. Armstrong, MD, MPH, professor and chief of dermatology at UCLA, and Chair Emeritus of the Medical Board of the National Psoriasis Foundation. These were the pivotal phase 3 POETYK PSO-1 and POETYK PSO-2 trials.²

This analysis continued the assessment of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor. The drug is approved in the European Union, the US, and other countries for adults with moderate-to-severe psoriasis who are also candidates for systemic treatment options.

“This analysis compared the effects of deucravacitinib versus placebo and apremilast on Psoriasis Symptoms and Signs Diary (PSSD) and the Dermatology Life Quality Index (DLQI) assessments in the POETYK PSO-1 and POETYK PSO-2 trials,” Armstrong and colleagues wrote.¹

Background and Design

The POETYK PSO-1 and PSO-2 investigators conducted the trials as global, multicenter, randomized, double-blind studies in which they drew comparisons regarding efficacy and safety between deucravacitinib, placebo, and apremilast. They randomly assigned subjects in a 1:2:1 ratio, giving them either deucravacitinib 6 mg once-per-day, apremilast 30 mg twice per-day, or placebo.

Individuals featured in POETYK PSO-1 who had been assigned to the deucravacitinib cohort continued therapy through to the 52-week mark. Those featured in POETYK PSO-1 and POETYK PSO-2 who had been first given a placebo were changed to deucravacitinib in a blinded manner at the 16-week mark.

The research team implemented the Psoriasis Symptoms and Signs Diary (PSSD) for the purposes of assessing participants’ symptom severity and signs. This evaluation covers 5 symptoms, namely pain, pruritus, burning, stinging, and skin tightness, as well as 6 signs, namely scaling, shedding, cracking, flaking, redness, and bleeding.

The PSSD involved a numeric scale from 0 (no symptoms) to 10 (worst possible symptoms). The team used the PSSD to generate summary scores for total signs and symptoms by averaging participants’ individual scores and then multiplying them by 10.

Subjects filled out the PSSD daily with a 24-hour recall, with investigators determining subjects’ weekly scores based on the average of daily scores for weeks during which the PSSD was filled out for at least 4 days. Additionally, the research team determined an improvement of 4 points from baseline in the Dermatology Life Quality Index (DLQI) would be the minimum clinically important difference for those with psoriasis.

Both of the analyses evaluated mean changes from the point of baseline in PSSD total, DLQI scores, symptom and sign scores, and reports of DLQI 0/1 among individuals with baseline DLQI scores of 2 or more. The team also assessed meaningful shifts in DLQI as well as the proportion of patients reporting significant within-patient changes in the PSSD.

Findings

Overall, the POETYK PSO-1 and PSO-2 research teams concluded that the 666 and 1020 participants, respectively, saw greater PSSD improvement from the point of baseline in their total score following administration of deucravacitinib (− 27.8 and − 30.1, respectively) compared to placebo (− 4.4 and − 5.9) and apremilast (− 18.9 and − 22.5) at the 16-week mark. This was also true when compared to apremilast at the 24-week mark with deucravacitinib (− 32.8 and − 30.7) compared to apremilast (− 21.6 and − 22.8, respectively) (nominal P < .0001).

The investigators found that subjects showed greater improvements with deucravactinib treatment from the point of baseline in their DLQI scores (− 8.5 and − 7.6) compared to those given placebo (− 3.3 and − 3.0) and those given apremilast (− 5.9 and − 5.8) at the 16-week mark.

This was also shown to be true with deucravacitinib compared to apremilast at the 24-week mark (− 8.6 and − 7.5, − 5.6 and − 5.5, respectively) (nominal P < .0001). Significant within-patient shifts in total PSSD scores and in DLQI score were achieved more commonly among those using deucravacitinib versus apremilast and versus placebo at the 16-week mark and versus apremilast at the 24-week mark.

“Deucravacitinib demonstrated rapid, durable, significant, and clinically meaningful improvements in psoriasis symptoms and signs and health-related QoL as reported by patients with moderate-to-severe plaque psoriasis,” they wrote. “Together with the efficacy and safety data from the POETYK PSO-1 and PSO-2 trials reported earlier, these findings further support the benefits of deucravacitinib in psoriasis.”

Referenced

1. ^{Armstrong AW, Augustin M, Beaumont JL, et al. Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials. Dermatol Ther (Heidelb) (2024). https://doi.org/10.1007/s13555-024-01224-x.}
2. ^{Strober B, Thaçi D, Foley P, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, Program fOr Evaluation of TYK2 inhibitor psoriasis second phase 3 trial. J Am Acad Dermatol. 2023;88(1):40–51.}