Apremilast in Japanese patients with palmoplantar pustulosis: A randomized, Phase 3 trial

Résumé fourni par la source

BACKGROUND: Palmoplantar pustulosis (PPP) is a difficult-to-treat chronic dermatitis with limited treatment options. OBJECTIVES: To report results from a Phase 3 study of apremilast in patients with moderate to severe PPP (NCT05174065). METHODS: In this randomized, placebo-controlled, double-blind, confirmatory study, Japanese adults with PPP Area and Severity Index (PPPASI) total score ≥12, PPPASI pustules/vesicles severity score ≥2 and inadequate response to topicals were randomly assigned (1:1) to apremilast or placebo for 16 weeks, followed by an active treatment phase where all patients received apremilast through Week 52. The primary endpoint was a ≥50% reduction in PPPASI total score (PPPASI-50) at Week 16, evaluated in all randomized patients. Safety outcomes were assessed in all patients who received ≥1 dose of the study drug. RESULTS: Between March 8, 2022 to April 28, 2023, 176 patients (141 [80%] women, 35 [20%] men) were randomly assigned to apremilast (n = 88 [50%]) or placebo (n = 88 [50%]). Mean (SD) PPPASI total score at baseline was 22.1 (8.1) in the apremilast group and 22.0 (8.4) in the placebo group. A significantly greater proportion of patients achieved PPPASI-50 at Week 16 with apremilast versus placebo (60 of 88 [68%] vs. 31 of 88 [35%]; treatment difference: 32.6% [95% CI: 18.7, 46.5], p < 0.0001). Improvements were maintained through Week 52. The most common adverse events (≥10% of patients) during the double-blind phase in patients receiving apremilast were diarrhea (placebo: n = 3 [3%]; apremilast: n = 17 [19%]), feces soft (placebo: n = 1 [1%]; apremilast: n = 15 [17%]), headache (placebo: n = 2 [2%]; apremilast: n = 10 [11%]) and nausea (placebo: n = 1 [1%]; apremilast: n = 10 [11%]). There were no events of depression or fatal adverse events. CONCLUSIONS: In this Phase 3 trial, apremilast was effective in Japanese patients with moderate to severe PPP. Adverse events were consistent with the known safety profile of apremilast. CLINICALTRIALS: gov: NCT05174065.

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