Abstract | BACKGROUND: Plaque psoriasis affecting palms and soles is disabling and often resistant to treatment. OBJECTIVE: 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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Authors | Alice Gottlieb, John Sullivan, Martijn van Doorn, Alexey Kubanov, Ruquan You, Anne Parneix, Sophie Hugot, Marina Milutinovic |
Journal | Journal of the American Academy of Dermatology
(J Am Acad Dermatol)
Vol. 76
Issue 1
Pg. 70-80
(Jan 2017)
ISSN: 1097-6787 [Electronic] United States |
PMID | 27707593
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Copyright | Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Dermatologic Agents
- secukinumab
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Topics |
- Adult
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Antibodies, Monoclonal, Humanized
- Dermatologic Agents
(adverse effects, therapeutic use)
- Double-Blind Method
- Female
- Foot Dermatoses
(drug therapy)
- Hand Dermatoses
(drug therapy)
- Humans
- Male
- Middle Aged
- Psoriasis
(drug therapy)
- Quality of Life
- Severity of Illness Index
- Treatment Outcome
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