WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.
“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”
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Dr. Jon M. Hanifin
Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.
The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.
The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.
Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).
The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.
Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.
Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.
CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.