Post-Hoc Analysis Re-Confirms Efficacy, Safety of Deucravacitinib for Psoriasis

Deucravacitinib is an effective and well-tolerated treatment option for patients with moderate to severe plaque psoriasis in Japan, according to recent post-hoc analysis findings, aligning with recent data in the POETYK PSO-4 study.1

These results represent the conclusion of new research led by Yukari Okubo, from the Department of Dermatology at Tokyo Medical University in Japan. The team of investigators noted that the open-label, phase 3 POETYK PSO-4 study had demonstrated deucravacitinib’s effectiveness over 52 weeks in Japanese patients with moderate to severe psoriasis.2

“Although overall efficacy and safety of deucravacitinib have been established in several Phase 3 trials in patients with moderate to severe plaque psoriasis, a more detailed characterization of patient populations appropriate for deucravacitinib treatment is needed,” Okubo and colleagues wrote.1 “The aim of this post hoc analysis of POETYK PSO-4 was to further clarify appropriate patient profiles by conducting detailed efficacy and safety analyses in Japanese patients with various baseline characteristics.”

The investigative team highlighted the most notable aspects of the POETYK PSO-4 study, including that adults aged 20 years and older had been involved in the study provided they had a static Physician Global Assessment (sPGA) score of at least 3, a Psoriasis Area and Severity Index (PASI) score of 12 or more, and baseline body surface area (BSA) disease involvement of 10% or more. These trial subjects were given open-label treatment with deucravacitinib at a dose of 6 mg on a once-per-day basis over a 52-week period.

The analysis had also involved individuals with generalized pustular psoriasis and erythrodermic psoriasis, but such patients were not included in the post-hoc analysis due to their small sample sizes. In this analysis, Okubo and colleagues assessed the treatment's long-term efficacy and safety, including recording the proportion of subjects achieving PASI thresholds of ≤1, ≤2, and ≤5, looking at any PASI sub-score improvements by body region, absolute PASI scores, and specific plaque features such as induration, erythema, and desquamation.

The investigative team also evaluated participants' rates of response for PASI 75, PASI 90, and sPGA scores of 0 (clear) or 1 (almost clear). Additionally, the team's subgroup analyses were based upon prior treatment with systemic therapies (biologic or non-biologic) as well as phototherapy. In their evaluation, Okubo et al. included subjects with psoriasis that was localized to the fingernails, scalp, and palms/soles. For safety monitoring, the investigators also assessed any adverse events.

Deucravacitinib therapy among patients with psoriasis was shown by the investigative team to lead to early absolute PASI score improvements beginning at the 1-week mark.1 There were also sustained benefits observed through the 52-week mark and, at the conclusion of the treatment period, 47.6% of trial subjects attained a PASI score of ≤1.

This score would suggest near-complete clearance of skin in their analysis. Regional PASI score improvements and individual plaque characteristic improvements were also shown by the team to appear as early as the 1-week mark. These results were maintained throughout the year.

Consistent efficacy was observed in this post-hoc analysis, regardless of any prior exposure to systemic therapies or to phototherapy. Additionally, the investigative team highlighted the clinical benefits seen in participants with scalp and nail involvement and among the smaller palmoplantar psoriasis patient subset.

Serious adverse events and any discontinuations of deucravacitinib due to adverse events were found to be infrequent, suggesting a strong safety profile. They also noted that occurrences of Grade 3 or higher laboratory abnormalities had been infrequent.

“Achievement of clinically relevant absolute PASI thresholds, effect of prior therapy, efficacy in hard-to-treat areas, and details about AEs of particular concern are presented to provide clinicians with a clearer picture of the degree and timing of onset of efficacy and potential AEs,” they wrote.1 “This is a clinically relevant publication that will help identify appropriate Japanese patients for whom deucravacitinib treatment should be prescribed.”

References

1. Okubo Y, Morita A, Imafuku S, et al (2025). Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Japanese Patients With Plaque Psoriasis: In-Depth Analysis of Efficacy and Safety in the Phase 3 POETYK PSO-4 Trial. J Dermatol. https://doi.org/10.1111/1346-8138.17744.

2. S Imafuku, Y Okubo, Y Tada, et al., “Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Japanese Patients With Moderate to Severe Plaque, Erythrodermic, or Generalized Pustular Psoriasis: Efficacy and Safety Results From an Open-Label, Phase 3 Trial,” Journal of Dermatology 51 (2024): 365–379.