Background: Secukinumab, a fully human monoclonal antibody (mAb) that selectively targets IL-17A, is highly efficacious in the treatment of moderate to severe plaque psoriasis, starting at early time points, with a sustained effect and a favorable safety profile. CLEAR is a phase 3b study comparing the efficacy and safety of secukinumab versus ustekinumab, an anti-IL-12/23 mAb, in adults with moderate to severe plaque psoriasis. This analysis focused on the treatment effect on skin-related quality of life as measured by the Dermatology Life Quality Index (DLQI).
Methods: Data from baseline to week 16 for patients aged greater than or equal to 18 years randomized 1:1 to subcutaneous treatment groups (secukinumab 300 mg and ustekinumab 45 mg or 90 mg according to body weight at baseline) were used for this analysis. The DLQI was administered at baseline and weeks 4, 8, 12, and 16 with total and subscale scores computed at all visits. DLQI response was defined as no effect of skin problems on health-related quality of life (DLQI total score of 0 or 1). Time to response was computed as the period from the randomization date to the time when DLQI 0/1 response had occurred. Median time to response was compared between treatment groups using Kaplan-Meier methods with a log-rank test.
Results: Mean (SD) baseline DLQI total scores were similar for both treatment arms: secukinumab 13.4 (7.63), ustekinumab 13.2 (7.57). The mean DLQI total score as well as all subscale scores (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment scores) improved (decreased) continuously over the treatment period in both treatment groups, with more pronounced improvements in the secukinumab arm than the ustekinumab arm at all visits (weeks 4, 8, 12, 16) (p less than 0.001 on DLQI total score). Up to week 16, 80.7% of subjects treated with secukinumab achieved DLQI response (0/1) versus 69.3% treated with ustekinumab (p less than 0.0001). The median time to DLQI response (0/1) was significantly shorter for secukinumab compared to ustekinumab (8 weeks vs. 12 weeks, p less than 0.0001).
Conclusion: Secukinumab treatment provides stronger and faster relief from patient-reported quality of life than ustekinumab in patients with moderate to severe plaque psoriasis.
