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

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. 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. 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. 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.