Serlopitant reduced pruritus in patients with prurigo nodularis in a phase 2, randomized, placebo-controlled trial.
BACKGROUNDAnecdotal evidence suggests that neurokinin 1 receptor antagonism reduces pruritus intensity in chronic pruritic conditions such as prurigo nodularis (PN).
OBJECTIVEThis study assessed safety and efficacy of the neurokinin 1 receptor antagonist serlopitant for treatment of pruritus in PN.
METHODSIn 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.
RESULTSAverage 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.
LIMITATIONSThe 8-week duration may be insufficient to assess clinically relevant resolution of PN lesions.
CONCLUSIONSSerlopitant reduced pruritus in patients with treatment-refractory PN and was well tolerated.
Center for Chronic Pruritus, Department of Dermatology, University Hospital Münster, Münster, Germany. Electronic address: Sonja.Staender@uni-muenster.de.,
Menlo Therapeutics Inc, Redwood City, California.,
Pacific Northwest Statistical Consulting, Inc, Woodinville, Washington.,
Velocity Pharmaceutical Development, LLC, South San Francisco, California.,
Department of Clinical Social Medicine, Occupational and Environmental Dermatology, University of Heidelberg, Heidelberg, Germany.,
Department of Dermatology, Venerology, and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.,
Department of Dermatology, University Hospital Münster, Münster, Germany.
Neurokinin-1 Receptor Antagonists
Visual Analog Scale
Pub Type(s)Journal Article
Randomized Controlled Trial