In the Journals

Serlopitant reduces pruritis in mild, moderate psoriasis

A daily regimen of oral serlopitant was associated with a significant reduction in pruritis in a small cohort of patients with mild to moderate psoriasis, according to a study.

“Pruritus, a common symptom of psoriasis, negatively affects quality of life,” David M. Pariser, MD, of the department of dermatology at Eastern Virginia Medical School and Virginia Clinical Research in Norfolk, and colleagues wrote. “However, treatment of lesional skin does not consistently alleviate psoriatic itch.”

The phase 2 trial included 204 patients overall, with 102 participants assigned a 5 mg dose of the neurokinin 1 receptor antagonist serlopitant (Menlo Therapeutics) and 102 assigned placebo for 8 weeks.

Eligible participants had plaque psoriasis covering 10% or less of their body surface area for at least 6 months, pruritis for at least 4 weeks and a Worst Itch Numeric Rating Scale (WI-NRS) score of 7 or greater at baseline screening.

The cohort was 85.2% white, with 54.2% women and a mean subject age of 47.5 years.

Patients in the serlopitant arm had a mean baseline WI-NRS score of 8.3 compared with 8.1 in the placebo arm. A 4-point response rate as assessed by WI-NRS at 8 weeks served as the primary endpoint.

In the serlopitant arm, 33.3% of subjects achieved the primary endpoint parameter compared with 21.1% in the placebo arm (P = .028).

At 4 weeks, the WI-NRS 4-point response rates were 20.8% for serlopitant and 11.5% for placebo, a key secondary endpoint (P = . 039).

Safety data showed that adverse events occurred in 4.9% of patients in the study drug arm and 4% of controls.

In terms of the secondary endpoint of mean absolute change in WI-NRS from baseline, serlopitant bested placebo at days 3 (–0.744; SD = 1.464 vs. –0.455; SD = 1.318) and 7 (–1.338; SD = 2.025 vs. –0.780; SD = 1.618).

Other findings showed that differences between the serlopitant and placebo arms as assessed by the 4-point responder scale held across demographic and baseline characteristics.

The researchers acknowledged the small sample size and exclusion of patients with severe disease as limitations of the analysis.

“Serlopitant signicantly reduced pruritus associated with mild to moderate psoriasis, supporting continued development of serlopitant for this patient population,” the researchers said. – by Rob Volansky

 

Disclosure: Pariser reports he is a consultant for, receives honoraria or grants/research funding from, and/or serves on an advisory board for Abbott, Amgen, Atacama Therapeutics, Bickel Biotechnology, Biofrontera, Celgene, Dermavant, Dermira, Dusa Pharmaceuticals, Eli Lilly, Leo Pharma, Menlo Therapeutics, Novartis, Ortho Dermatologics, Peplin, Pfizer, Photocure, Promius, Regeneron, Sanofi, TDM SurgiTech, Stiefel, TheraVida and Valeant. Please see the study for all other authors’ relevant financial disclosures.

A daily regimen of oral serlopitant was associated with a significant reduction in pruritis in a small cohort of patients with mild to moderate psoriasis, according to a study.

“Pruritus, a common symptom of psoriasis, negatively affects quality of life,” David M. Pariser, MD, of the department of dermatology at Eastern Virginia Medical School and Virginia Clinical Research in Norfolk, and colleagues wrote. “However, treatment of lesional skin does not consistently alleviate psoriatic itch.”

The phase 2 trial included 204 patients overall, with 102 participants assigned a 5 mg dose of the neurokinin 1 receptor antagonist serlopitant (Menlo Therapeutics) and 102 assigned placebo for 8 weeks.

Eligible participants had plaque psoriasis covering 10% or less of their body surface area for at least 6 months, pruritis for at least 4 weeks and a Worst Itch Numeric Rating Scale (WI-NRS) score of 7 or greater at baseline screening.

The cohort was 85.2% white, with 54.2% women and a mean subject age of 47.5 years.

Patients in the serlopitant arm had a mean baseline WI-NRS score of 8.3 compared with 8.1 in the placebo arm. A 4-point response rate as assessed by WI-NRS at 8 weeks served as the primary endpoint.

In the serlopitant arm, 33.3% of subjects achieved the primary endpoint parameter compared with 21.1% in the placebo arm (P = .028).

At 4 weeks, the WI-NRS 4-point response rates were 20.8% for serlopitant and 11.5% for placebo, a key secondary endpoint (P = . 039).

Safety data showed that adverse events occurred in 4.9% of patients in the study drug arm and 4% of controls.

In terms of the secondary endpoint of mean absolute change in WI-NRS from baseline, serlopitant bested placebo at days 3 (–0.744; SD = 1.464 vs. –0.455; SD = 1.318) and 7 (–1.338; SD = 2.025 vs. –0.780; SD = 1.618).

Other findings showed that differences between the serlopitant and placebo arms as assessed by the 4-point responder scale held across demographic and baseline characteristics.

The researchers acknowledged the small sample size and exclusion of patients with severe disease as limitations of the analysis.

“Serlopitant signicantly reduced pruritus associated with mild to moderate psoriasis, supporting continued development of serlopitant for this patient population,” the researchers said. – by Rob Volansky

 

Disclosure: Pariser reports he is a consultant for, receives honoraria or grants/research funding from, and/or serves on an advisory board for Abbott, Amgen, Atacama Therapeutics, Bickel Biotechnology, Biofrontera, Celgene, Dermavant, Dermira, Dusa Pharmaceuticals, Eli Lilly, Leo Pharma, Menlo Therapeutics, Novartis, Ortho Dermatologics, Peplin, Pfizer, Photocure, Promius, Regeneron, Sanofi, TDM SurgiTech, Stiefel, TheraVida and Valeant. Please see the study for all other authors’ relevant financial disclosures.