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

卷:78

Article

Yosipovitch, Gil¹  Stander, Sonja²  Kerby, Matthew B.³  Larrick, James W.⁴  Perlman, Andrew J.⁴  Schnipper, Edward F.⁴  Zhang, Xiaoming³  Tang, Jean Y.⁵  Luger, Thomas⁶  Steinhoff, Martin^7,8 

[1] Univ Miami, Miller Sch Med, Dept Dermatol & Cutaneous Surg, Miami Itch Ctr, Coral Gables, FL 33124 USA

[2] Univ Hosp Munster, Dept Dermatol, Ctr Chron Pruritus, Munster, Germany

[3] Menlo Therapeut Inc, Redwood City, CA USA

[4] Velocity Pharmaceut Dev LLC, San Francisco, CA USA

[5] Stanford Univ, Dept Clin Dermatol, Redwood City, CA USA

[6] Univ Hosp Munster, Dept Dermatol, Munster, Germany

[7] Univ Calif San Diego, Dept Dermatol, La Jolla, CA 92093 USA

[8] Weill Cornell Univ Qatar, Hamad Med Corp, Dept Dermatol, Doha, Qatar

关键词: chronic pruritus;    itch;    neurokinin 1 receptor;    NK1 receptor;    NK1 receptor antagonist;    serlopitant;    substance P;   

DOI  :  10.1016/j.jaad.2018.02.030

来源: Elsevier

【 摘 要 】

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).

【 授权许可】

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