Serlopitant (Menlo Therapeutics), an investigational drug that blocks the sensation of itch in the brain, significantly reduced pruritus associated with psoriasis in a phase 2 randomized, double-blind, clinical trial.
"Psoriasis is one of the most common dermatoses and, clearly, regardless of the severity of the psoriasis, a vast number of patients have severe itch," said senior investigator Mary Spellman, MD, chief medical officer of Menlo Therapeutics in Redwood City, California.
"The condition can negatively affect quality of life, and the treatment of lesions in psoriasis does not consistently relieve psoriatic itch. We really believe that serlopitant could meet an unmet medical need," she told Medscape Medical News.
Serlopitant is an oral neurokinin-1 (NK1) receptor antagonist being studied for the treatment of pruritus related to various conditions in addition to psoriasis, including prurigo nodularis and chronic pruritus of unknown origin.
Spellman presented data from a study of 204 patients 18 to 84 years of age during a late-breaking clinical trials session at the American Academy of Dermatology 2019 Annual Meeting in Washington, DC.
The mean age of the study participants was 47.5 years, 54.2% were women, and 85.2% were white. Half were randomized to daily serlopitant 5 mg and half to placebo for 8 weeks.
All had been diagnosed with plaque psoriasis at least 6 months before randomization, with plaques covering less than 10% of body surface area. In addition, patients had pruritus that lasted at least 4 weeks and, at screening, a Worst Itch Numeric Rating Scale (WI-NRS) of at least 7, which is consistent with severe pruritus.
The only other psoriasis therapies patients were allowed to use during the study period were bland emollients.
At baseline, mean WI-NRS scores were similar in the serlopitant and placebo groups (8.3 vs 8.1).
The primary efficacy end point at week 8 was a 4-point improvement in WI-NRS score, and a key secondary end point was a 4-point improvement at week 4.
|Table. Achievement of a 4-Point Improvement in WI-NRS Score|
|Timepoint||Serlopitant Group, %||Placebo Group, %||P Value|
The rate of treatment-related adverse events was slightly higher in the serlopitant group than in the placebo group (4.9% vs 4.0%).
These results strongly support a phase 3 study in the same population and the continued "development of serlopitant toward a New Drug Application and, ultimately, FDA approval of the medication," said Spellman. "So we continue to study this."
"Chronic itch is a major problem and there are no FDA-approved treatments for this bothersome symptom," said Joel Gelfand, MD, from the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.
"In many cases, it can be so severe that it disturbs sleep and can lead to mood disorders and even suicide," he told Medscape Medical News.
"The data presented are highly encouraging and offer hope to the millions of people suffering with chronic itch," Gelfand added.
"I am certainly in favor of Spellman's recommendation that the oral once-daily neurokinin-1 receptor antagonist should continue to be developed," said Robert Brodell, MD, from the University of Mississippi Medical Center in Jackson.
"The 'heartbreak of psoriasis' involves both the appearance of the condition and the associated itching, which does not affect every individual with psoriasis, but probably does affect 50%," he explained.
"Antihistamines offer relief for some patients, but a new first-in-class drug would be welcome if studies continue to show that it is safe and effective," he added.
The study was funded by Menlo Therapeutics. Spellman is chief medical officer at Menlo Therapeutics. Gelfand has been a consultant for Menlo Therapeutics in the past. Brodell has disclosed no relevant financial relationships.
American Academy of Dermatology (AAD) 2019 Annual Meeting. Presented March 2, 2019.
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Cite this: Novel Agent Reduces Severe Pruritus in Psoriasis - Medscape - Mar 02, 2019.