期刊
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
卷 76, 期 1, 页码 70-80出版社
MOSBY-ELSEVIER
DOI: 10.1016/j.jaad.2016.07.058
关键词
palmoplantar psoriasis; clear or almost clear skin; clinical trial; secukinumab; superiority; quality of life
类别
资金
- Novartis Pharma AG, Basel, Switzerland
Background: Plaque psoriasis affecting palms and soles is disabling and often resistant to treatment. Objective: Evaluate the efficacy and safety of secukinumab, an anti-interleukin 17A antibody, in subjects with palmoplantar psoriasis. Methods: In this double-blinded, randomized controlled trial, 205 subjects were randomized 1: 1: 1 to secukinumab 300 mg, 150 mg, or placebo. The primary endpoint was Palmoplantar Investigator's Global Assessment (ppIGA) 0 (clear) or 1 (almost clear/minimal) response at week 16. Results: At week 16, the percentage of subjects who achieved clear or almost clear palms and soles (or ppIGA 0/1) with secukinumab 300 mg (33.3%) and 150 mg (22.1%) was superior to the percentage achieved with placebo (1.5%, P < . 001). Palmoplantar Psoriasis Area and Severity Index (ppPASI) was significantly reduced with secukinumab 300 mg (-54.5%) and 150 mg (-35.3%) compared with placebo (-4.0%, P < . 001). Dermatology Life Quality Index (DLQI) 0/1 responses from subjects in the secukinumab groups were also significantly higher compared with placebo at week 16 (P < . 01) and pain and function of palms and soles was markedly improved with secukinumab as measured by the palmoplantar Quality-of-Life Instrument. Secukinumab 300 mg consistently showed the best outcomes. The safety profile was favorable and similar to previous studies. Limitations: Lack of active comparator. Conclusion: In GESTURE, the largest randomized controlled trial in palmoplantar psoriasis, secukinumab demonstrated the greatest efficacy to date for treating difficult-to-treat psoriasis.
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