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Efficacy of Apremilast in Patients with Psoriasis with Limited Skin Involvement, Including High-Impact Site Involvement: A Pooled Analysis of Six Trials

Year: 2026

Type: article

Abstract: INTRODUCTION: Plaque psoriasis is associated with decreased quality of life (QOL) even in patients with limited skin involvement, particularly those with high-impact site (HIS) involvement. The efficacy of apremilast in patients with plaque psoriasis has been demonstrated in phase 3 and 4 clinical trials. Here, we evaluated the efficacy of apremilast across six clinical trials for patients with psoriasis with low affected body surface area (BSA), including patients with HIS involvement. METHODS: Data were pooled across five randomized, double-blind, placebo-controlled trials (patients were randomized to apremilast or placebo until week 16, followed by open-label apremilast) and one single-arm, open-label trial of apremilast for the treatment of plaque psoriasis. Patients in this post hoc pooled analysis had limited skin involvement (BSA, 3-10%), many with HIS involvement in the scalp, genital area, and/or nails. Week 16 and 32 assessments included BSA, Psoriasis Area and Severity Index (PASI), static Physician's Global Assessment, Dermatology Life Quality Index, and HIS-specific measurements. Nonresponder imputation was used for missing data for binary endpoints; a mixed-effects model for repeated measures was used to analyze continuous endpoints. RESULTS: Of 1152 patients in this analysis (mean BSA, 6.3%; PASI, 6.8), those who received apremilast (n = 671) versus placebo (n = 481) had significantly greater improvements in skin clearance and QOL at week 16 (all endpoints assessed, p < 0.0001), with improvements generally maintained at week 32. Apremilast also yielded clinically greater improvements in patients with scalp, genital, and/or nail psoriasis at week 16 versus placebo (all endpoints assessed in affected patients, p < 0.01), with responses generally maintained at week 32. CONCLUSION: Apremilast improved skin clearance and QOL at week 16, and responses were generally maintained at week 32, in a pooled population of patients with psoriasis with limited skin involvement, including HIS involvement. Graphical abstract available for this article. Trial Registration ClinicalTrials.gov identifiers-NCT03721172, NCT03777436, NCT03123471, NCT03774875, NCT02425826, and NCT03930186.

Source: Dermatology and Therapy

DOI: 10.1007/s13555-026-01921-9