Sustained efficacy of secukinumab in patients with moderate‐to‐severe palmoplantar psoriasis: 2·5‐year results from GESTURE , a randomized, double‐blind, placebo‐controlled trial

Abstract

Summary Background Secukinumab has shown sustained efficacy and safety in several manifestations of psoriasis. Objectives GESTURE investigated the long‐term (2·5‐year) safety and efficacy of 150 mg and 300 mg subcutaneous secukinumab in 205 patients with moderate‐to‐severe palmoplantar psoriasis. Methods GESTURE was a randomized, double‐blind, placebo‐controlled, multicentre, phase IIIb trial conducted across 15 countries. The study was 140 weeks long and consisted of four periods: screening (up to 4 weeks), treatment period 1 (16 weeks), treatment period 2 (116 weeks) and post‐treatment follow‐up (8 weeks). Eligible patients were aged ≥ 18 years with moderate‐to‐severe palmoplantar psoriasis and at least one plaque outside of the palms and soles. Efficacy was assessed via a palmoplantar Investigator's Global Assessment (ppIGA) and the palmoplantar Psoriasis Area and Severity Index (PASI). Results The primary end point, a ppIGA score of 0 or 1, was met at week 16. The effect was sustained over 2·5 years with 59% [95% confidence interval (CI) 43·5–74·1] and 53% (95% CI 35·1–69·6) of patients in the secukinumab 300 mg and 150 mg groups, respectively, achieving clear or almost clear palms and soles (ppIGA 0 or 1). At 2·5 years, the mean palmoplantar PASI percentage was reduced in both the secukinumab 300 mg group (−74·7%) and the secukinumab 150 mg group (−61·6%). A total of 17% (secukinumab 300 mg group) and 18% (secukinumab 150 mg group) of patients experienced no difficulty in hands and feet functionality, as indicated by the palmoplantar quality of life instrument overall scores. The safety profile was favourable. Conclusions GESTURE revealed that secukinumab provides a strong and sustained response over 2·5 years in challenging‐to‐treat palmoplantar psoriasis.

Effectiveness and safety of secukinumab in patients with moderate‐severe psoriasis: A multicenter real‐life study

“…In particular 90% reduction in PASI (PASI90), from baseline PASI score, and 100% reduction in PASI (PASI100) were recorded, respectively, in 79% and 44.3% of patients after 16 weeks of therapy; in both cases these rates were significantly higher compared to ustekinumab ( P < .001) 15 . Several other phase III trials demonstrated its long‐lasting efficacy in many different clinical manifestations of psoriasis, including nails, scalp, palmoplantar, and joints 16‐18 …”

“…15 Several other phase III trials demonstrated its long-lasting efficacy in many different clinical manifestations of psoriasis, including nails, scalp, palmoplantar, and joints. [16][17][18] Although data regarding the long-term sustained efficacy and safety of secukinumab are available from randomized clinical trials, 19 there is a need to increase real-world studies on this topic. Indeed, real-world patients with psoriasis are very different from those enrolled in clinical trials, which can strongly influence biologic treatment clinical outcomes as well as the course of disease.…”

Risk of candidiasis associated with interleukin-17 inhibitors: A real-world observational study of multiple independent sources

“…Biologics inhibiting the T-helper (Th)-17 pathway have been approved for plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis, 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 and are currently under investigation for rheumatoid arthritis. 9 This group of biologics include IL-17 inhibitors (secukinumab, ixekizumab, brodalumab), and IL-12/23 inhibitors (IL-12/23p40 (ustekinumab), IL-23p19 (guselkumab)).…”

Palmoplantar Psoriasis Successfully Treated With Risankizumab

“…Unfortunately, palmoplantar psoriasis is also frequently resistant to treatment, making it quite a therapeutic challenge [2]. Biologic therapies, such as secukinumab, an anti-interleukin (IL) 17A monoclonal antibody, have been highly effective in the management of resistant palmoplantar psoriasis, as shown in the 2PRECISE randomized controlled trial [3] and GESTURE trial [4]. Risankizumab, another biologic therapy, is a humanized immunoglobulin (Ig) G1 monoclonal antibody that targets the p19 subunit of IL-23 [5].…”