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Serlopitant reduced pruritus in patients with prurigo nodularis in a phase 2, randomized, placebo-controlled trial - 12/04/19

Doi : 10.1016/j.jaad.2019.01.052 
Sonja Ständer, MD a, , Paul Kwon, MD b, Joe Hirman, PhD c, Andrew J. Perlman, MD, PhD d, Elke Weisshaar, MD e, Martin Metz, MD f, Thomas A. Luger, MD g
for the

TCP-102 Study Group

a Center for Chronic Pruritus, Department of Dermatology, University Hospital Münster, Münster, Germany 
b Menlo Therapeutics Inc, Redwood City, California 
c Pacific Northwest Statistical Consulting, Inc, Woodinville, Washington 
d Velocity Pharmaceutical Development, LLC, South San Francisco, California 
e Department of Clinical Social Medicine, Occupational and Environmental Dermatology, University of Heidelberg, Heidelberg, Germany 
f Department of Dermatology, Venerology, and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany 
g Department of Dermatology, University Hospital Münster, Münster, Germany 

Reprint requests: Sonja Ständer, MD, Center for Chronic Pruritus, Department of Dermatology, University Hospital Münster, Von-Esmarch-Strasse 58, 48149 Münster, Germany.Center for Chronic PruritusDepartment of DermatologyUniversity Hospital MünsterVon-Esmarch-Strasse 58Münster48149Germany

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.


© 2019  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 80 - N° 5

P. 1395-1402 - mai 2019 Retour au numéro
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