Serlopitant reduced pruritus in patients with prurigo nodularis in a phase 2, randomized, placebo-controlled trial
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 i...
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| Main Authors: | , |
|---|---|
| Format: | Article (Journal) |
| Language: | English |
| Published: |
March 17, 2019
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| In: |
Journal of the American Academy of Dermatology
Year: 2019, Volume: 80, Issue: 5, Pages: 1395-1402 |
| ISSN: | 1097-6787 |
| DOI: | 10.1016/j.jaad.2019.01.052 |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1016/j.jaad.2019.01.052
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| Author Notes: | Sonja Ständer, Paul Kwon, Joe Hirman, Andrew J. Perlman, Elke Weisshaar, Martin Metz, Thomas A. Luger, for the TCP-102 Study Group |
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| 245 | 1 | 0 | |a Serlopitant reduced pruritus in patients with prurigo nodularis in a phase 2, randomized, placebo-controlled trial |c Sonja Ständer, Paul Kwon, Joe Hirman, Andrew J. Perlman, Elke Weisshaar, Martin Metz, Thomas A. Luger, for the TCP-102 Study Group |
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| 520 | |a 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. | ||
| 650 | 4 | |a Adult | |
| 650 | 4 | |a Aged | |
| 650 | 4 | |a Chronic Disease | |
| 650 | 4 | |a Diarrhea | |
| 650 | 4 | |a Double-Blind Method | |
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| 650 | 4 | |a Female | |
| 650 | 4 | |a Humans | |
| 650 | 4 | |a Isoindoles | |
| 650 | 4 | |a Male | |
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| 650 | 4 | |a Nasopharyngitis | |
| 650 | 4 | |a neurokinin 1 receptor | |
| 650 | 4 | |a neurokinin 1 receptor antagonist | |
| 650 | 4 | |a Neurokinin-1 Receptor Antagonists | |
| 650 | 4 | |a Prurigo | |
| 650 | 4 | |a prurigo nodularis | |
| 650 | 4 | |a pruritus | |
| 650 | 4 | |a Pruritus | |
| 650 | 4 | |a serlopitant | |
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