Efficacy and Safety of Apremilast in Patients with Mild to Moderate Psoriasis: Results from the 16- Week, Double-Blind Phase of the ADVANCE Trial

Document Type

Conference Proceeding

Publication Date

10-27-2021

Publication Title

J Cutan Med Surg

Abstract

Introduction: Patients with mild to moderate psoriasis report substantial disease burden despite lower psoriasis-involved body surface area (BSA). Apremilast 30 mg BID (APR) is approved for moderate to severe psoriasis. We report efficacy and safety of APR in patients with mild to moderate psoriasis from the phase 3 ADVANCE trial. Methods, Results: Methods: ADVANCE was a multicenter, randomized, placebo (PBO)-controlled, double-blind study of biologic-naive adults with mild to moderate plaque psoriasis (static Physician's Global Assessment [sPGA] 2-3, BSA 2%- 15%, Psoriasis Area and Severity Index [PASI] 2-15) inadequately controlled with or intolerant to ≥1 topical therapy. Results: Among patients who completed the 16-week double-blind phase (258 APR and 246 PBO), baseline mean psoriasis duration (16.9 y), mean BSA (6.4%), mean PASI score (6.5), mean DLQI total score (9.9), and scalp psoriasis prevalence (69%) were similar between groups. The primary endpoint was met, with significantly greater achievement of sPGA score of 0 or 1 and ≥2-point reduction from baseline with APR vs. PBO at Week 16 (21.6% [95% CI 16.7-26.4] vs. 4.1% [95% CI 1.8-6.4]; P < 0.0001). The following secondary and post hoc endpoints were significantly greater (all P < 0.0001) with APR vs. PBO at Week 16 (all P < 0.0001): BSA-75: 33% APR vs. 7% PBO BSA ≤3%: 61% APR vs. 23% PBO WBI-NRS: 43% APR vs. 19% PBO ScPGA: 44% APR vs. 17% PBO DLQI improvement ≥5 points: 61% APR vs. 34% PBO No deaths were reported. Treatment-emergent adverse events ≥5% in either group were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection. Conclusions: In this phase 3 study in mild to moderate psoriasis, APR demonstrated clinically meaningful and statistically significant improvements vs. PBO in overall psoriasis severity, special areas (eg, scalp), and patient-reported outcomes (eg, whole body itch and quality of life). AEs were consistent with the known safety profile of APR. Learning Objective Review the ADVANCE multicenter, randomized, placebo-controlled, double-blind study conducted in the US and Canada that evaluated the efficacy and safety of apremilast in biologic-naive patients with mild to moderate plaque psoriasis. Review the first report of the efficacy and safety of apremilast at week 16 in the ADVANCE study. Assess the primary endpoint (sPGA response) and secondary endpoint results of apremilast vs placebo in ADVANCE. Takeaway Message In the phase 3 ADVANCE study, apremilast demonstrated clinically meaningful and statistically significant improvements over placebo in overall PsO severity, special areas such as the scalp, and relevant patient-reported outcomes.

Volume

25

Issue

1 SUPPL

First Page

65S

Last Page

66S

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