Serlopitant for psoriatic pruritus: A phase 2 randomized, double-blind, placebo-controlled clinical trial - 16/03/20

Doi : 10.1016/j.jaad.2020.01.056

David M. Pariser, MD ^a, Jerry Bagel, MD ^b, Mark Lebwohl, MD ^c, Gil Yosipovitch, MD ^d, Elaine Chien, MD ^e, Mary C. Spellman, MD ^f,^⁎
^a Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research, Inc, Norfolk, Virginia
^b Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey
^c Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York
^d Miami Itch Center, Department of Dermatology, University of Miami, Miller School of Medicine, Miami, Florida
^e Independent Contractor, Palo Alto, California
^f Menlo Therapeutics, Inc, Redwood City, California

^∗Correspondence to: Mary Spellman, MD, 28 Miguel St, San Francisco, CA 94131.28 Miguel StSan FranciscoCA94131

En prensa. Pruebas corregidas por el autor. Disponible en línea desde el Monday 16 March 2020

Abstract

Background

Pruritus, a common symptom of psoriasis, negatively affects quality of life; however, treatment of lesional skin does not consistently alleviate psoriatic itch.

Objective

To examine the effects of serlopitant, an oral, once-daily neurokinin 1 receptor antagonist, for treatment of psoriatic pruritus in a phase 2, randomized clinical trial (NCT03343639).

Methods

Patients (n = 204) were randomized to receive serlopitant, 5 mg, or placebo daily for 8 weeks. Eligible adult patients had plaque psoriasis for ≥6 months, plaques covering ≤10% of body surface area, pruritus for ≥4 weeks, and Worst Itch Numeric Rating Scale (WI-NRS) score ≥7 at the initial screening.

Results

Participants (54.2% women) had a mean age of 47.5 years and 85.2% were white. Mean baseline WI-NRS scores were 8.3 for serlopitant and 8.1 for placebo. The WI-NRS 4-point response rate at 8 weeks (primary end point) was 33.3% for serlopitant vs 21.1% for placebo (P = .028); at 4 weeks the rates were 20.8% for serlopitant vs 11.5% for placebo (P = .039). Treatment-related adverse events were reported for 4.9% of serlopitant-treated and 4.0% of placebo-treated patients.

Limitations

This was a phase 2 study with a small study population. Patients with severe psoriasis were excluded.

Conclusion

Serlopitant significantly reduced pruritus associated with mild to moderate psoriasis, supporting continued development of serlopitant for this patient population.

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Key words : clinical trial, neurokinin 1 receptor (NK₁R), pruritus, psoriasis, serlopitant, substance P

Abbreviations used : BSA, NK1, NRS, PGA, SAEs, TEAEs, WI-NRS

Esquema

	Funding sources: This study was funded by Menlo Therapeutics, Inc. Medical writing and editorial support for this manuscript was provided by Meredith Rogers, MS, CMPP, of The Lockwood Group (Stamford, CT), which was in accordance with Good Publication Practice (GPP3) guidelines and funded by Menlo Therapeutics, Inc.
	Conflicts of interest: Dr Pariser reports being a consultant, receiving honoraria, or grants/research funding, and/or serving on an advisory board for Abbott, Amgen, Atacama Therapeutics, Bickel Biotechnology, Biofrontera AG, Celgene, Dermavant, Dermira, DUSA Pharmaceuticals, Eli Lilly, LEO Pharma, Menlo Therapeutics, Novartis, Ortho Dermatologics, Peplin, Pfizer, Photocure ASA, Promius, Regeneron, Sanofi, TDM SurgiTech, Stiefel, TheraVida, and Valeant. Dr Bagel reports speaking, serving on an advisory board, and/or serving as an investigator for Novartis, Eli Lilly, Celgene, LEO Pharma, Janssen, BMS, Boehringer-Ingelheim, AbbVie, USB, and Amgen. Dr Lebwohl is an employee of Mount Sinai, which receives research funds from AbbVie, Amgen, AstraZeneca, Boehringer-Ingelheim, Celgene, Eli Lilly, Incyte, Janssen/Johnson & Johnson, Kadmon, LEO Pharma, MedImmune, Novartis, Pfizer, Sciderm, UCB, Ortho Dermatologics, and ViDac. Dr. Lebwohl is also a consultant for Allergan, Almirall, Arcutis, Avotres, Birch Biomed, Boehringer-Ingelheim, Bristol-Myers Squibb, Cara, Castle Biosciences, Dermavant, Encore, Inozyme, LEO Pharma, Meiji, Menlo Therapeutics, Mitsubishi Pharma, Neuroderm LTD, Pfizer, Promius/Dr. Reddy, Theravance Biopharma, and Verrica. Dr Yosipovitch reports being a consultant, receiving honoraria, or grants/research funding, and serving on an advisory board for Menlo Therapeutics, TREVI, Sienna, Sanofi, Regeneron, Eli Lilly, Novartis, Pfizer, LEO Pharma, AbbVie, Vanda, Kiniksa, Sun Pharma, CeraVe, Galderma, and Bellus. Dr Chien reports being an independent contractor engaged by Menlo Therapeutics at the time the research was conducted. Dr Spellman was an employee of Menlo Therapeutics at the time the research was conducted.
	IRB approval status: An Institutional Review Board approved the study protocol and its amendments.