Clinical Trial Brings Hope for Prurigo Nodularis Patients

Marcia Frellick

March 10, 2017

ORLANDO — For patients with prurigo nodularis, the neurokinin 1 (NK1) receptor antagonist serlopitant is more effective than placebo, and is well tolerated, according to results from a phase 2 clinical trial.

"This population is desperate because there's no approved treatment," said lead researcher Sonja Ständer, MD, from the University of Munster in Germany.

Patients with this disorder "suffer from the visibility of the lesions and they are itchy," she told Medscape Medical News. These are the first data that offer some hope, she added.

Prurigo nodularis can occur at any age, but it usually affects middle-aged and elderly people. There are different underlying causes for the disorder, such as chronic kidney disease and atopic dermatitis, but treating these is often not enough, Dr Ständer said here at the American Academy of Dermatology Annual Meeting.

The NK1 receptor is widely expressed in the central nervous system, is also expressed in the skin, and is implicated in the transmission of the itch signal, she explained.

The randomized, double-blind, placebo-controlled trial involved 127 adults as old as 80 years (mean age, 57.6 years) who were severely affected by prurigo nodularis for at least 6 weeks. It was conducted at 15 sites in Germany.

The patients were randomized to 8 weeks of treatment with oral serlopitant 5 mg or placebo. The two groups were matched for age, sex, atopic predisposition, and intensity of itch.

At week 8, the reduction in average itch from baseline during the previous 24 hours — rated on a visual analog scale — was significantly greater in the serlopitant group than in the placebo group (3.6 vs 1.9 cm; P = .0005). And the decrease in itch intensity was seen as soon as week 2.

Serlopitant was also superior to placebo for several secondary end points, the researchers report.

As expected, the patients who had an atopic predisposition responded better than those who did not, Dr Ständer noted.

Patients Needed for Phase 3 Trial

The next step is a phase 3 trial, said Dr Ständer. "The first trial was short and we saw a reduction in itch intensity. The next step is to monitor whether the lesions are healing."

Adverse effects related to the drug were mild to moderate, she reported, and no significant safety signals were detected.

This research represents a significant advance, said Andrew Blauvelt, MD, president and owner of the Oregon Medical Research Center in Portland.

"Prurigo nodularis is the bane of the existence of many patients, and the dermatologists trying to treat it," he told Medscape Medical News. The disorder is unresponsive to antihistamines and other drugs that treat itch, he pointed out.

The study is striking, first, because it was done at all, he explained. "As far as I know, there's no FDA-approved drug for prurigo nodularis."

The results show that "if you go specifically after the nerve associated with growth factors in the skin, you can knock down itch and improve these patients," Dr Blauvelt noted.

He said he is heartened by the possibility of a treatment for a group of patients with no other options.

Dr Ständer reports ties to Tigercat Pharma and Trevi Therapeutics. Dr Blauvelt reports ties to AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, Genentech, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Sandoz, Sanofi Genzyme, Sun Pharma, UCB, and Valeant.

American Academy of Dermatology (AAD) Annual Meeting: Abstract F056-5198. Presented March 4, 2017.

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