Serlopitant for the treatment of chronic pruritus: Results of a randomized, multicenter, placebo-controlled phase 2 clinical trial - 19/04/18
Abstract |
Background |
The substance P/neurokinin 1 receptor pathway is critical in chronic pruritus; anecdotal evidence suggests that antagonism of this pathway can reduce chronic itch.
Objective |
To assess the safety and efficacy of the substance P/neurokinin 1 receptor antagonist serlopitant in treating chronic pruritus.
Methods |
Eligible patients with severe chronic pruritus who were refractory to antihistamines or topical steroids were randomized to serlopitant, 0.25, 1, or 5 mg, or to placebo, administered once daily for 6 weeks as monotherapy or with midpotency steroids and emollients. The primary efficacy end point was percentage change in visual analog scale pruritus score from baseline.
Results |
Serlopitant treatment resulted in a dose-dependent decrease in pruritus. The mean percentage decreases from baseline visual analog scale pruritus scores were statistically significantly larger with the 1- and 5-mg doses of serlopitant (P = .022 and P = .013, respectively) than with placebo at week 6. No significant safety or tolerability differences were detected among the groups.
Limitations |
The sample size was insufficient for subgroup analyses of the efficacy of serlopitant for chronic pruritus on the basis of underlying conditions.
Conclusions |
Serlopitant, 1 mg and 5 mg daily, was associated with a statistically significant reduction in chronic pruritus and was well tolerated (NCT01951274).
Le texte complet de cet article est disponible en PDF.Key words : chronic pruritus, itch, neurokinin 1 receptor, NK1 receptor, NK1 receptor antagonist, serlopitant, substance P
Abbreviations used : DLQI, e-diary, NK1R, NRS, PGA, PSSQ-I, SGA, SP, VAS
Plan
| Drs Yosipovitch and Ständer are cofirst authors. |
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| Funding sources: Supported by Menlo Therapeutics Inc. Medical writing and editorial assistance were provided by ApotheCom (New York, NY) and funded by Menlo Therapeutics Inc. |
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| Disclosure: Dr Yosipovitch has received grant/research support for his role as an investigator from Menlo Therapeutics Inc, Vanda Pharmaceuticals, Kiniksa Pharmaceuticals, and Sun Pharma, and he has received honoraria for participation in advisory boards for Menlo Therapeutics Inc, Trevi, Novartis, Pfizer, OPKO Health Inc, Sanofi, Galderma, and Sienna. Dr Ständer has received grants/research support and honoraria for her role as an investigator and consultant from Menlo Therapeutics Inc; she has received honoraria for participation in advisory boards for Menlo Therapeutics Inc and has received patient fees from Menlo Therapeutics Inc. Dr Kerby has received personal fees from Velocity Pharmaceutical Development and is a shareholder and consultant to Menlo Therapeutics Inc. Dr Larrick is a cofounder of and owns stock in Menlo Therapeutics Inc. Drs Perlman and Schnipper are employees of Velocity Pharmaceutical Development, and they have received stock from Menlo Therapeutics Inc for their roles as advisors and consultants. Dr Zhang has received personal fees from Velocity Pharmaceutical Development; he is a shareholder and employee of Menlo Therapeutics Inc, and he reports patents issued to Menlo Therapeutics Inc. Dr Luger has received grant/research support for his role as an investigator from AbbVie, Celgene, Eli Lily, Janssen-Cilag, Mylan/Meda Pharmaceuticals, MSD, Novartis, and Pfizer, and he has received honoraria for participation in advisory boards for AbbVie, Celgene, CERIES, Eli Lilly, Galderma, Janssen-Cilag, La Roche Posay, Mylan/Meda, Novartis, and Pfizer and honoraria for his role as a speaker for AbbVie, Celgene, Galderma, Janssen-Cilag, La Roche Posay, Mylan/Meda, MSD, Novartis, and Pfizer. Dr Steinhoff has received honoraria for his role as a speaker from Menlo Therapeutics Inc, Galderma, and Eli Lily; for serving as a consultant for Menlo Therapeutics Inc; and for participating in advisory boards for Menlo Therapeutics Inc, Galderma, and Pierre Fabre Laboratories. Dr Tang has no conflicts of interest to disclose. |
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| This work was submitted to and presented in part at the 26th European Academy of Dermatology and Venereology Congress, September 13-17, 2017, in Geneva, Switzerland, and presented at the Ninth World Congress on Itch, October 15-17, 2017, in Wroclaw, Poland. |
Vol 78 - N° 5
P. 882 - mai 2018 Retour au numéro
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