Efficacy of Secukinumab in Patients With Mild to Moderate Psoriasis: A Pooled Analysis of 6 Phase 3 Studies

Abstract

Introduction: Secukinumab has demonstrated sustained long-term efficacy for the treatment of patients with moderate to severe plaque psoriasis, but efficacy in mild to moderate psoriasis has not been rigorously evaluated. The secukinumab phase 3 clinical trial program included patients with mild to moderate psoriasis among populations with active psoriatic arthritis (EXCEED and FUTURE 2-5; NCT02745080, NCT01752634, NCT01989468, NCT02294227, and NCT02404350), and among patients with moderate to severe palmoplantar psoriasis (GESTURE; NCT01806597). Here, we report efficacy and safety of secukinumab in a pooled population of patients with mild to moderate psoriasis.

Methods: This post hoc analysis included patients from the phase 3 EXCEED, FUTURE 2-5, and GESTURE trials, with mild to moderate psoriasis defined as either a baseline affected body surface area (BSA) of 3%-10% or a baseline Investigator’s Global Assessment modified 2011 score (IGA) of 2 or 3. Patients were pooled by treatment received through Week 16 (treatment period 1) and from Weeks 16 to 52 (treatment period 2), according to the following groups: treatment period 1 (secukinumab 300 mg, secukinumab 150 mg, or placebo) and treatment period 2 (secukinumab 300 mg or secukinumab 150 mg). Efficacy was assessed by the proportion of patients achieving 75% improvement in the Psoriasis Area and Severity Index (PASI75), PASI90, and PASI100 among patients with a BSA 3%-10%; and by IGA 0/1 response with ≥2-point improvement among patients with baseline IGA score of 2 or 3. Descriptive statistics were reported for each outcome. Missing data were imputed using non-responder imputation.

Results: Overall, 654 patients and 971 patients had mild to moderate psoriasis at baseline as defined by a BSA of 3%-10% or IGA score of 2 or 3, respectively. Demographics and baseline disease characteristics were similar between populations defined by BSA and by IGA. Among patients with a baseline BSA of 3%-10%, secukinumab resulted in greater achievement of PASI75/90/100 vs placebo at Week 12 (secukinumab 300 mg: 62.8%/44.4%/33.1%; secukinumab 150 mg: 48.0%/29.1%/19.4%; placebo: 11.7%/9.0%/8.0%), with increased responses at Week 52 (secukinumab 300 mg: 65.7%/56.5%/47.3%; secukinumab 150 mg: 58.1%/40.5%/31.3%). The proportion of patients with baseline IGA=2 or 3 achieving IGA 0/1 response with ≥2-point improvement was greater among patients receiving secukinumab 300 mg (46.6%) or 150 mg (37.2%) than placebo (8.6%) at Week 12, with increased responses at Week 52 (secukinumab 300 mg: 52.5%; secukinumab 150 mg: 44.4%).

Conclusions: Secukinumab led to improvements in measures of disease severity among patients with mild to moderate psoriasis after 12 weeks of treatment vs placebo in a pooled analysis of patients with psoriatic arthritis or palmoplantar psoriasis. Both doses of secukinumab showed increased efficacy from Week 12 to Week 52.