Secukinumab shows significant efficacy in palmoplantar psoriasis: Results from GESTURE, a randomized controlled trial - 18/04/17
, John Sullivan, MD b, Martijn van Doorn, MD c, Alexey Kubanov, MD d, Ruquan You, MSc e, Anne Parneix, MD f, Sophie Hugot, MSc g, Marina Milutinovic, MD gAbstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : palmoplantar psoriasis, clear or almost clear skin, clinical trial, secukinumab, superiority, quality of life
Abbreviations used : AE, BSA, DLQI, EQ-5D, HRQoL, IGA, IgG, IL, PASI, ppIGA, ppPASI, ppPGA, ppQLI, QoL, SAE, SGA
Plan
| Supported by Novartis Pharma AG, Basel, Switzerland. |
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| Disclosure: Dr Gottlieb has served as a consultant and advisory board member for Amgen Inc, Astellas, Akros, Centocor Inc (Janssen), Celgene Corp, Bristol Myers Squibb Co, Beiersdorf Inc, Abbott Labs (AbbVie), TEVA, Actelion, UCB, Novo Nordisk, Novartis, Dermipsor Ltd, Incyte, Pfizer, Canfite, Lilly, Coronado, Vertex, Karyopharm, CSL Behring Biotherapies for Life, Glaxo Smith Kline, Xenoport, Catabasis, Meiji Seika Pharma Co Ltd, Takeda, Mitsubishi and Tanabe Pharma Development America Inc, and Genentech and has received research and educational grants from Centocor Inc (Janssen), Amgen Inc, Abbott Labs (AbbVie), Novartis, Celgene, Pfizer, Lilly, Coronado, Levia, Merck, Xenoport, and Dermira. Dr Sullivan has participated in advisory boards for Novartis Australia. Dr van Doorn has participated in advisory boards for Janssen, Pfizer, MSD, and Leopharma and received a research grant from Janssen and Pfizer. Mr You, Dr Parneix, Ms Hugot, and Dr Milutinovic are employees of and/or own stock in Novartis. Dr Kubanov has no conflict of interest to declare. |
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| Previously presented in the form of an oral presentation at the 23rd World Congress of Dermatology (Vancouver, BC, Canada, June 2015). |
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| Reprints not available from the authors. |
Vol 76 - N° 1
P. 70-80 - janvier 2017 Retour au numéro
Article précédent
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