Serlopitant for the treatment of chronic pruritus: Results of a randomized, multicenter, placebo-controlled phase 2 clinical trial

Gil Yosipovitch, Sonja Ständer, Matthew B. Kerby, James W. Larrick, Andrew J. Perlman, Edward F. Schnipper, Xiaoming Zhang, Jean Y. Tang, Thomas Luger, Martin Steinhoff

Research output: Contribution to journalArticle

49 Scopus citations

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).

Original languageEnglish (US)
Pages (from-to)882-891.e10
JournalJournal of the American Academy of Dermatology
Volume78
Issue number5
DOIs
StatePublished - May 2018

Keywords

  • NK1 receptor
  • NK1 receptor antagonist
  • chronic pruritus
  • itch
  • neurokinin 1 receptor
  • serlopitant
  • substance P

ASJC Scopus subject areas

  • Dermatology

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    Yosipovitch, G., Ständer, S., Kerby, M. B., Larrick, J. W., Perlman, A. J., Schnipper, E. F., Zhang, X., Tang, J. Y., Luger, T., & Steinhoff, M. (2018). Serlopitant for the treatment of chronic pruritus: Results of a randomized, multicenter, placebo-controlled phase 2 clinical trial. Journal of the American Academy of Dermatology, 78(5), 882-891.e10. https://doi.org/10.1016/j.jaad.2018.02.030