Efficacy and safety of apremilast in patients with moderateto-severe plaque psoriasis of the scalp: Results of a Phase III, multicenter, randomized, placebocontrolled, double-blind study
Van Voorhees A, Stein Gold L, Lebwohl M, Strober B, Lynde C, Tyring S, Cauthen A, Sofen H, Zhang Z, Paris M, and Wang Y. Efficacy and safety of apremilast in patients with moderateto-severe plaque psoriasis of the scalp: Results of a Phase III, multicenter, randomized, placebocontrolled, double-blind study. J Clin Aesthet Dermatol 2019; 12(5):S21.
J Clin Aesthet Dermatol
Background/Objective: Many patients with psoriasis report that they are most bothered by symptoms in difficult-to-treat, highly visible, pruritic areas, such as the scalp. Topical therapies can be difficult to apply to the scalp area. We evaluated efficacy and safety of apremilast, an oral PDE4 inhibitor indicated for treatment of moderateto- severe plaque psoriasis, in patients with moderate-tosevere scalp psoriasis. Methods: This was a Phase III, multicenter, doubleblind, placebo (PBO)-controlled study in patients with moderate-to-severe plaque psoriasis of the scalp (scalp Physician Global Assessment [ScPGA] ≥3 [moderate or greater]; psoriasis-involved scalp surface area [SSA] ≥20%) with inadequate response/intolerance to one or more topical therapy and moderate-to-severe plaque psoriasis (Psoriasis Area and Severity Index [PASI] ≥12, psoriasis-involved body surface area [BSA] ≥10%; static PGA [sPGA] ≥3 [moderate or greater]). Patients were randomized to apremilast 30mg twice daily (BID) (APR) or PBO through Week 16 and continued or switched to APR through Week 32. The primary endpoint, proportion of patients achieving ScPGA response at Week 16 (score of 0 [clear] or 1 [almost clear] with ≥2-point reduction from baseline) with APR versus PBO, and secondary endpoints (proportion of patients with ≥4-point improvement from baseline in whole body itch and scalp itch numeric rating scale (NRS) scores and change from baseline at Week 16 in Dermatology Quality of Life Index [DLQI] total score) were evaluated using the Cochran-Mantel-Haenszel method for binary endpoints and analysis of covariance model for continuous endpoints with missing values imputed using the multiple imputation method. Results: In all, 303 patients were randomized (APR n=201, PBO n=102). Baseline demographics were generally comparable between APR and PBO groups (mean [SD] age, 47.0 [15.0] and 46.7 [15.2] years; mean [SD] disease duration, 15.7 [12.4] and 14.8 [11.3] years). At baseline, mean (SD) values for APR and PBO, respectively, were as follows: SSA, 61.9 percent (27.2) and 58.2 percent (26.4); scalp itch NRS, 6.6 (2.5) and 6.7 (2.4); BSA, 19.0% (10.8) and 21.2% (14.8); whole body itch NRS, 7.2 (2.3) and 7.2 (2.0); and DLQI, 12.6 (7.0) and 12.6 (7.2). At Week 16, significantly more patients treated with APR versus PBO achieved the primary endpoint (43.4% vs. 13.8%, P<0.0001). In addition, in patients treated with APR, 47.0 percent and 45.3 percent achieved four-orgreater- point improvement from baseline in scalp itch and whole body itch NRS scores versus 21.3 percent and 22.5 percent of patients treated with PBO (P≤0.0001 for both comparisons). Statistically significant improvements with APR versus PBO were observed on both itch NRS measures as early as Week 2 (scalp: 26.0% vs. 11.5%; whole body: 20.5% vs. 3.5%; P<0.01 and P<0.0001, respectively). Improvement from baseline in DLQI score at Week 16 was significantly greater with APR versus PBO (least-square means, -7.1 vs. -4.2, P<0.0001). Common AEs, occurring in five percent or more of patients in either treatment group, were diarrhea (30.5% and 10.8%), nausea (21.5% and 5.9%), headache (11.5% and 4.9%), and vomiting (5.5% and 2.0%) with APR and PBO, respectively. Conclusion: Findings demonstrated the efficacy of APR in patients with moderate-to-severe psoriasis of the scalp. AEs were consistent with the known safety profile of apremilast.