Risankizumab Effective, Safe for Moderate-to-Severe Palmoplantar Pustulosis

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Risankizumab treatment of patients aged 18 or older with palmoplantar pustulosis led to sustained improvements in signs and symptoms of the disease, new findings suggest, showing a consistent safety profile with prior safety data reported in other risankizumab studies on psoriasis.¹

These data were the conclusion of new research evaluating risakizumab in Japanese patients, the results of which were authored by Yukari Okubo from the department of dermatology at Tokyo Medical University Hospital. Okubo and colleagues highlighted risankizumab’s design as a humanized immunoglobin G1 monoclonal antibody, formulated specifically as an IL-23 inhibitor.

“The efficacy of [risankizumab] in patients with psoriasis has been demonstrated in clinical trials; however, the efficacy of [risankizumab] for the treatment of [palmoplantar pustulosis] in randomized, placebo-controlled clinical trials has not been published,” Okubo et al. wrote. “Here, we report the primary and long-term efficacy and safety data of [risankizumab] in treating Japanese adults with [palmoplantar pustulosis].”^1,2

Findings on Risankizumab in Adults with Palmoplantar Pustulosis

Okubo and colleagues' JumPPP study (NCT04451720) was designed as a phase 3, randomized, multicenter, placebo-controlled, double-blind analysis. They looked at Japanese adults who were shown to have moderate-to-severe palmoplantar pustulosis through a Palmoplantar Pustulosis Area and Severity Index (PPPASI) score of ≥12.

Additionally, the investigative team required those included as subjects to have pustules or vesicles which were rated as moderate or severe on at least a single palm or sole, as indicated through a PPPASI severity score ≥2. They must also have previously had an inadequate response or intolerance to standard therapies for the skin condition, including vitamin D3 derivatives, topical corticosteroids, phototherapy, or systemic etretinate.

During the screening period, the team required participants not to exceed a 5-point PPPASI improvement to ensure stable disease activity. Completed focal infection procedures were also required of subjects at least 24 weeks prior to administration with risanizumab, unless such procedures were found not to be necessary with necessary follow-up care.

Using a 1:1 ratio, subjects of the analysis were randomized to either be treated with 150 mg of risankizumab or a placebo at the 0 and 4-week marks. Subjects initially placed in the risankizumab arm of the trial carried on with treatment through the 52-week mark, whereas the investigators switched subjects in the placebo arm to the medication at the 16-week mark and continued through to Week 56.

A shift in subjects' PPPASI scores from baseline was deemed to be the primary endpoint of the trial. In terms of secondary endpoints, examples included the proportion of those attaining PPPASI 50 (≥50% improvement) and PPPASI 75 at the 16-week mark. Outcomes related to efficacy were tracked through to the 68-week mark and safety signals were monitored through to Week 76.

Overall, the study findings at the 16-week mark showed that individuals treated with risankizumab had significantly greater PPPASI score improvements than those in the placebo arm (least squares mean treatment difference: −3.48; P < .05). The investigative team further highlighted a greater percentage of individuals in the risankizumab arm achieving a PPPASI 50 score versus those given a placebo (41.0% versus 24.1%; nominal P < .05).

Despite these positive results, the team did also note a lack of significant difference in participants' PPPASI 75 attainment between both cohorts (13.1% versus 15.5%; nominal P = .74).

They did note generally sustained severity improvements through Week 68, adding that the drug's safety profile remained consistent with prior psoriasis studies. Additionally, no unexpected safety concerns were highlighted by the team.

“These comprehensive results from the JumPPP study showed clinically meaningful and durable efficacy of [risankizumab] over time in patients with [palmoplantar pustulosis],” they wrote. “...Overall, these results suggest that [risankizumab] may be an effective long-term treatment option for the effective management of [palmoplantar pustulosis].”¹

References

1. Okubo Y, Murakami M, Kobayashi S, Tsuji S, Kishimoto M, Ikeda K, et al. Risankizumab in Japanese patients with moderate-to-severe palmoplantar pustulosis: Results from the randomized, phase 3 JumPPP study. J Dermatol. 2025; 00: 1–10. https://doi.org/10.1111/1346-8138.17659.

2. Blauvelt A, Leonardi CL, Gooderham M, Papp KA, Philipp S, Wu JJ, et al. Efficacy and safety of continuous risankizumab therapy vs treatment withdrawal in patients with moderate to severe plaque psoriasis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020; 156: 649–658.