Serlopitant reduced pruritus in patients with prurigo nodularis in a phase 2, randomized, placebo-controlled trial - 12/04/19
for the
TCP-102 Study Group
Abstract |
Background |
Anecdotal evidence suggests that neurokinin 1 receptor antagonism reduces pruritus intensity in chronic pruritic conditions such as prurigo nodularis (PN).
Objective |
This study assessed safety and efficacy of the neurokinin 1 receptor antagonist serlopitant for treatment of pruritus in PN.
Methods |
In this randomized, double-blind, placebo-controlled study, 128 patients with chronic, treatment-refractory PN for more than 6 weeks received serlopitant, 5 mg, or placebo orally once daily for 8 weeks. The primary end point was change in average itch visual analog scale score at weeks 4 and 8.
Results |
Average itch visual analog scale scores significantly improved with serlopitant versus with placebo at weeks 4 and 8: the least squares mean difference (serlopitant minus placebo) was −1.0 at week 4 (P = .02) and −1.7 at week 8 (P < .001). The least squares mean difference between serlopitant and placebo reached statistical significance at week 2 (−0.9 [P = .011]). The most frequently reported treatment-emergent adverse events in the serlopitant group were nasopharyngitis, diarrhea, and fatigue.
Limitations |
The 8-week duration may be insufficient to assess clinically relevant resolution of PN lesions.
Conclusions |
Serlopitant reduced pruritus in patients with treatment-refractory PN and was well tolerated.
Le texte complet de cet article est disponible en PDF.Key words : neurokinin 1 receptor, neurokinin 1 receptor antagonist, prurigo nodularis, pruritus, serlopitant
Abbreviations used : AEs, IGA, LS, NK1R, NRS, PN, SE, TEAEs, VAS, VRS
Plan
Funding sources: Supported by Menlo Therapeutics Inc. |
|
Disclosure: Dr Ständer is a principal investigator for Menlo Therapeutics Inc, Dermasence, Trevi Therapeutics, Galderma, and Novartis and a member of scientific advisory boards for Beiersdorf, Celgene, Galderma, Kiniksa, Menlo Therapeutics Inc, NeRRe Therapeutics, Sienna, and Trevi Therapeutics. Dr Kwon is chief scientific officer at Menlo Therapeutics Inc. Dr Hirman has received personal fees from Menlo Therapeutics Inc. Dr Perlman is an employee of Velocity Pharmaceutical Development and a shareholder of Menlo Therapeutics Inc, and he reports a patent (“Use of NK-1 Receptor Antagonists in Pruritus”) issued to Menlo Therapeutics Inc. Dr Weisshaar has received a research grant from Fresenius Medical Care and has participated in clinical studies for Menlo Therapeutics Inc and Trevi Therapeutics. Dr Metz has received honoraria as a speaker and/or consultant for Bayer Pharma, Beiersdorf, Celgene, GlaxoSmithKline, Jenapharm, Menlo Therapeutics Inc, Merz Pharma, Moxie GmbH, NeRRe Therapeutics, Novartis, Pierre Fabre, Roche, Sanofi, and Shire. Dr Luger has received grant/research support from AbbVie, Celgene, Janssen-Cilag, Mylan/Meda, MSD, Novartis, Pfizer, and Wolff, and he has participated in advisory boards for AbbVie, Celgene, Ceres Pharmaceuticals, Galderma, Janssen-Cilag, La Roche-Posay, Mylan/Meda, Novartis, Pfizer, Sandoz, Sanofi-Aventis, Symrise, Menlo Therapeutics Inc, LEO Pharma, Pierre Fabre, and PIQUR Therapeutics. |
Vol 80 - N° 5
P. 1395-1402 - mai 2019 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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