Moderate-to-severe atopic dermatitis patients enrolled in a clinical trial of rocatinlimab — a novel, patient-tailored monoclonal antibody therapy — showed encouraging results while taking the drug and for up to 20 weeks after treatment stopped , researchers at Mount Sinai reported on lancet.
The results suggest that rocatinlimab has the potential to alter the genetic makeup of human atopic dermatitis long-term and may help maintain long-lasting results without continued use, the researchers said. Rocatinlimab inhibits OX40, an immune molecule involved in the activation of inflammatory cells that play a key role in the development of atopic dermatitis and other inflammatory diseases.
“Atopic dermatitis, the most common type of eczema, is a debilitating chronic inflammatory skin disease that affects one in 10 Americans and millions worldwide,” said Waldman Professor and System Chair, The Kimberly and Eric J, MD, Emma Guttman, MD. Waldman Dermatology; Director, Eczema Center of Excellence; Director, Inflammatory Dermatology Laboratory, Icahn School of Medicine at Mount Sinai. “It usually occurs at an early age and causes skin inflammation, redness, extreme itching, pain, and very dryness—all symptoms that can greatly affect a patient’s quality of life. We are very optimistic about the results of this trial and the potential for long-term effects that improve disease and improve patients’ quality of life. “
In this Phase 2b multicenter, double-blind, placebo-controlled study, 274 patients (rocatinlimab: n=217; placebo: n=57) were enrolled in a 1:1:1:1:1 dose every 4 weeks. Proportionally randomized to rocatinlimab (150 mg or 600 mg) or biweekly (300 mg or 600 mg) or placebo subcutaneously until week 18 with an active treatment extension of 18 weeks and a follow-up of 20 weeks. The trial was conducted at 65 sites in the United States, Canada, Japan and Germany.
The percent change from baseline in the Eczema Area and Severity Index (EASI) score was assessed as the primary endpoint at Week 16 and was achieved for all active rocatinlimab doses (-48% to -61%) compared to placebo Significance (-15%) compared with placebo was achieved. All active dose groups also continued to improve after week 16, with the majority of patients remaining responsive for at least 20 weeks after stopping treatment.
The results support rocatinlimab as a safe and effective treatment for moderate-to-severe atopic dermatitis with potential durable efficacy and disease-modifying effects. Reported adverse events were generally similar between the rocatinlimab groups. Common adverse events during the double-blind period included fever, chills, headache, aphthous ulcers (mouth sores), and nausea.
“At week 36, all participants had received at least 18 weeks of treatment,” added Dr. Gutmann, the study’s senior author. “By this time, we saw that while the drug met its primary endpoint at all doses compared to placebo, it was also a drug that improved over time, which is indeed the case with currently available treatment options. Unusual and unique.”
The researchers plan to continue this investigation in Phase 3 of the project in 2023. Future studies will also include larger study populations, longer follow-up, and exploration of combination therapies (eg, rocatinlimab plus topical corticosteroids).
This trial is registered with ClinicalTrials.gov (NCT03703102).