Serlopitant reduced pruritus in patients with prurigo nodularis in a phase 2, randomized, placebo-controlled trial.
Adult
Aged
Chronic Disease
Diarrhea
/ chemically induced
Double-Blind Method
Fatigue
/ chemically induced
Female
Humans
Isoindoles
/ adverse effects
Male
Middle Aged
Nasopharyngitis
/ chemically induced
Neurokinin-1 Receptor Antagonists
/ adverse effects
Prurigo
/ complications
Pruritus
/ drug therapy
Visual Analog Scale
neurokinin 1 receptor
neurokinin 1 receptor antagonist
prurigo nodularis
pruritus
serlopitant
Journal
Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132
Informations de publication
Date de publication:
May 2019
May 2019
Historique:
received:
31
05
2018
revised:
17
01
2019
accepted:
21
01
2019
pubmed:
22
3
2019
medline:
30
4
2019
entrez:
22
3
2019
Statut:
ppublish
Résumé
Anecdotal evidence suggests that neurokinin 1 receptor antagonism reduces pruritus intensity in chronic pruritic conditions such as prurigo nodularis (PN). This study assessed safety and efficacy of the neurokinin 1 receptor antagonist serlopitant for treatment of pruritus in PN. 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. 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. The 8-week duration may be insufficient to assess clinically relevant resolution of PN lesions. Serlopitant reduced pruritus in patients with treatment-refractory PN and was well tolerated.
Sections du résumé
BACKGROUND
BACKGROUND
Anecdotal evidence suggests that neurokinin 1 receptor antagonism reduces pruritus intensity in chronic pruritic conditions such as prurigo nodularis (PN).
OBJECTIVE
OBJECTIVE
This study assessed safety and efficacy of the neurokinin 1 receptor antagonist serlopitant for treatment of pruritus in PN.
METHODS
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
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
CONCLUSIONS
The 8-week duration may be insufficient to assess clinically relevant resolution of PN lesions.
CONCLUSIONS
CONCLUSIONS
Serlopitant reduced pruritus in patients with treatment-refractory PN and was well tolerated.
Identifiants
pubmed: 30894279
pii: S0190-9622(19)30161-6
doi: 10.1016/j.jaad.2019.01.052
pii:
doi:
Substances chimiques
Isoindoles
0
Neurokinin-1 Receptor Antagonists
0
serlopitant
277V92K32B
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1395-1402Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.