The investigative agent serlopitant appears to offer some relief from the disfiguring and intensely itchy skin eruptions of prurigo nodularis, according to results of a phase 2 study presented at the 2017 Annual Meeting of the American Academy of Dermatology (AAD).
Sonja Stander, MD, University Hospital Munster, Munster, Germany and colleagues administered 5-mg tablets of oral serlopitant daily to 64 patients, resulting in a reduction of 3.6-cm of average itch on a visual analog scale, while 63 subjects on placebo averaged a 1.9-cm reduction in itch on the scale, a difference that was statistically significant at 8 weeks.
The researchers also reported that, as treatment with serlopitant continued, patients improved. The difference in itch score at 8 weeks was significantly better than at 4 weeks (P = .0005).
"The proportion of patients receiving serlopitant with at least a 4-cm response by week 8 on average itch visual analog scale was at least 2 times that of subjects receiving placebo," said Dr. Stander. In addition, most of the subgroups favoured treatment with serlopitant over placebo.
"Serlopitant was well tolerated among patients with refractory prurigo nodularis, with the majority of adverse events being mild or moderate," Dr. Stander added at an oral late-breaker session here on March 4. "These findings support further evaluation of serlopitant for the treatment of prurigo nodularis."
In the trial, conducted at 15 sites in Germany, adult subjects 60 years of age or younger were enrolled to be assigned to either serlopitant or placebo. All subjects had had at least 6 weeks duration of prurigo nodularis eruptions that persisted on both arms, both legs, or trunk despite treatments.
Primary patients were treated for 8 weeks and assessed 2 week later.
Subjects in this study had a mean age of 58 years, and were split between men and women; all were white. About 30% of the subjects said their disease had been apparent for at least 10 years; only 10% of subjects had had the condition for less than a year.
Prurigo nodularis is a chronic skin disease characterised by intensely pruritic papulonodular eruptions. The condition is frequently associated with systemic and atopy-related conditions. In most cases, the aetiology of the disease is unclear.
Serlopitant is a small-molecule, highly potent and selective NK1-R antagonist.
Funding for this study is provided by Menlo Therapeutics, Menlo Park, California.
[Presentation title: A Randomized, Double-Blind, Placebo-Controlled, Study of the Neurokinin-I Receptor (NKl-R) Antagonist Serlopitant in Subjects with Prurigo Nodularis. Abstract 5198]