Secukinumab clears “mild-to-moderate” psoriasis: a randomized, placebo-controlled exploratory clinical trial
Description
Background: All psoriasis biologics are tested in randomized clinical trials (RCTs) exclusively for severe psoriasis and not indicated for “mild-to-moderate” psoriasis. Objective: To demonstrate the efficacy of IL-17A antagonist secukinumab for “mild-to-moderate” psoriasis. Methods: A randomized, double-blinded, placebo-controlled exploratory phase II clinical trial to test secukinumab for “mild-to-moderate” psoriasis reporting histologic and gene expression modifications observed in psoriasis skin (NCT03131570). The primary outcome measure was the proportion of subjects who have ≥75% reduction in Psoriasis Area-and-Severity Index (PASI75) at week 12. Skin biopsies were analyzed by immunohistochemistry and multiple RT-PCR assays. Results: Secukinumab led to greater rates of PASI75 response (72.7%) at week 12 compared with placebo (0%) (P < 0.005). 100% of mild-to-moderate psoriasis patients achieved PASI75 16 weeks after the initiation of injections. 89% of mild-to-moderate psoriasis patients achieved ≥90% reduction in PASI (PASI90) 20 weeks after the initiation of injections. Systemic secukinumab injection reversed keratinocyte hyperproliferation, and decreased T-cell and dendritic cell numbers and pathogenic psoriatic gene expressions (P < 0.005). Limitations: The study was exploratory with limited sample size. Conclusion: IL17A inhibitors are effective for “mild-to-moderate” psoriasis.