Tags

Type your tag names separated by a space and hit enter

Serlopitant reduced pruritus in patients with prurigo nodularis in a phase 2, randomized, placebo-controlled trial.

Abstract

BACKGROUND

Anecdotal evidence suggests that neurokinin 1 receptor antagonism reduces pruritus intensity in chronic pruritic conditions such as prurigo nodularis (PN).

OBJECTIVE

This study assessed safety and efficacy of the neurokinin 1 receptor antagonist serlopitant for treatment of pruritus in PN.

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

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

The 8-week duration may be insufficient to assess clinically relevant resolution of PN lesions.

CONCLUSIONS

Serlopitant reduced pruritus in patients with treatment-refractory PN and was well tolerated.

Links

  • FREE Publisher Full Text
  • Authors+Show Affiliations

    ,

    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.

    Source

    MeSH

    Adult
    Aged
    Chronic Disease
    Diarrhea
    Double-Blind Method
    Fatigue
    Female
    Humans
    Isoindoles
    Male
    Middle Aged
    Nasopharyngitis
    Neurokinin-1 Receptor Antagonists
    Prurigo
    Pruritus
    Visual Analog Scale

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    30894279

    Citation

    Ständer, Sonja, et al. "Serlopitant Reduced Pruritus in Patients With Prurigo Nodularis in a Phase 2, Randomized, Placebo-controlled Trial." Journal of the American Academy of Dermatology, vol. 80, no. 5, 2019, pp. 1395-1402.
    Ständer S, Kwon P, Hirman J, et al. Serlopitant reduced pruritus in patients with prurigo nodularis in a phase 2, randomized, placebo-controlled trial. J Am Acad Dermatol. 2019;80(5):1395-1402.
    Ständer, S., Kwon, P., Hirman, J., Perlman, A. J., Weisshaar, E., Metz, M., & Luger, T. A. (2019). Serlopitant reduced pruritus in patients with prurigo nodularis in a phase 2, randomized, placebo-controlled trial. Journal of the American Academy of Dermatology, 80(5), pp. 1395-1402. doi:10.1016/j.jaad.2019.01.052.
    Ständer S, et al. Serlopitant Reduced Pruritus in Patients With Prurigo Nodularis in a Phase 2, Randomized, Placebo-controlled Trial. J Am Acad Dermatol. 2019;80(5):1395-1402. PubMed PMID: 30894279.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Serlopitant reduced pruritus in patients with prurigo nodularis in a phase 2, randomized, placebo-controlled trial. AU - Ständer,Sonja, AU - Kwon,Paul, AU - Hirman,Joe, AU - Perlman,Andrew J, AU - Weisshaar,Elke, AU - Metz,Martin, AU - Luger,Thomas A, AU - ,, Y1 - 2019/03/17/ PY - 2018/05/31/received PY - 2019/01/17/revised PY - 2019/01/21/accepted PY - 2019/3/22/pubmed PY - 2019/4/30/medline PY - 2019/3/22/entrez KW - neurokinin 1 receptor KW - neurokinin 1 receptor antagonist KW - prurigo nodularis KW - pruritus KW - serlopitant SP - 1395 EP - 1402 JF - Journal of the American Academy of Dermatology JO - J. Am. Acad. Dermatol. VL - 80 IS - 5 N2 - BACKGROUND: Anecdotal evidence suggests that neurokinin 1 receptor antagonism reduces pruritus intensity in chronic pruritic conditions such as prurigo nodularis (PN). OBJECTIVE: This study assessed safety and efficacy of the neurokinin 1 receptor antagonist serlopitant for treatment of pruritus in PN. 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: 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: The 8-week duration may be insufficient to assess clinically relevant resolution of PN lesions. CONCLUSIONS: Serlopitant reduced pruritus in patients with treatment-refractory PN and was well tolerated. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/30894279/Serlopitant_reduced_pruritus_in_patients_with_prurigo_nodularis_in_a_phase_2,_randomized,_placebo-controlled_trial L2 - https://linkinghub.elsevier.com/retrieve/pii/S0190-9622(19)30161-6 DB - PRIME DP - Unbound Medicine ER -