UM Dermatologist Co-Authors Groundbreaking Study of Nemolizumab for Itch Relief in New England Journal of Medicine
A new medication offers hope to patients with prurigo nodularis, a rare nodular skin disease that causes intense itching. “Clinicians need an effective treatment for prurigo nodularis, and a monoclonal antibody called nemolizumab has shown promising results in its initial trials,” said Gil Yosipovitch, M.D., director of the Miami Itch Center and professor in the Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery at the University of Miami Miller School of Medicine.
Dr. Gil Yosipovitch
Dr. Yosipovitch was second author of a study, “Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis,” published February 20 in the New England Journal of Medicine. Sonja Ständer, M.D., of the Department of Dermatology and Center for Chronic Pruritus at University Hospital in Münster, Germany, was the senior author of the study, which focused on the results of a multicenter phase 2 trial involving researchers from Germany, Austria, France, Poland, and Switzerland as well as the United States.
“This was the first controlled double-blind study with a biologic treatment for prurigo nodularis,” said Dr. Yosipovitch, who designed the collaborative phase 2 nemolizumab clinical trial, sponsored by Galderma. “A majority of participants showed a significant reduction in itch severity and in their skin lesions.”
Prurigo nodularis is a rare, underreported disease, affecting 200,000 to 300,000 people in the U.S., according to Dr. Yosipovitch. “We see a steady stream of these patients in our Miller School clinic,” he added. “Many find it difficult to sleep at night because the intense itching leads to chronic scratching, which leads to development of nodules. Because the skin lesions are often large and unsightly, many patients avoid social situations, limiting their quality of life.”
Dr. Yosipovitch said the symptoms of prurigo nodularis can begin at any age but are most common in adults between 50 and 65. The incidence appears to be higher in African-Americans, women and the elderly. “This is one of the most protracted and difficult itch conditions to treat,” he said. “Patients use a variety of topical and oral medications, but nothing seems to provide more than short-term relief.”
Nemolizumab, a monoclonal antibody targeting the interleukin-31 receptor, had already shown positive results for moderate to severe atopic dermatitis, making it a potential candidate for prurigo nodularis, Dr. Yosipovitch said.
In the new clinical trial, 70 patients were randomly assigned to nemolizumab or a placebo, and given injections at the start of the trial, and after four and eight weeks. Participants were measured on the pruritus numeric rating scale to determine if there was a reduction in itch intensity. They also completed a Dermatology Life Quality Index and were given a skin examination, along with medication safety checks.
The initial NRS score for both groups was 8.4, at the high end of the 0-10 itching scale. After four weeks, the participants receiving nemolizumab reported a 53 percent reduction in itch severity, compared with 20.2 percent for those with the placebo. All the other measures showed a positive difference in participants taking nemolizumab. At the end of the study, 38 percent of the patients who received nemolizumab were clear or almost clear of the disease compared with 6 percent of the patients who received a placebo.
“Nemolizumab resulted in a higher percentage of improvement of pruritus and skin lesions in prurigo nodularis,” said Dr. Yosipovitch. “Larger and longer trials are required to determine the durability and safety of this promising treatment.”
Tags: Dr. Gil Yosipovitch, nemolizumab, New England Journal of Medicine