Patients showed significant improvement in signs and symptoms up to 20 weeks after stopping medication – Zoo House News

Patients with moderate to severe atopic dermatitis enrolled in a clinical trial of rocatinlimab — a novel, patient-specific monoclonal antibody therapy — showed promising results both while taking the drug and up to 20 weeks after stopping therapy, Mount researchers said Sinai reports in The Lancet.

The researchers said the results suggest that rocatinlimab has the potential to alter a person’s atopic dermatitis genetic makeup in the long term and potentially help maintain lasting results without continued use. Rocatinlimab inhibits OX40 – an immune molecule involved in activating 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 condition that affects 1 in 10 Americans and millions of people worldwide,” said Emma Guttman, MD, PhD, Waldman Professor and Systems Chair, The Kimberly and Eric J Waldman Department of Dermatology; Director, Center of Excellence in Eczema; and director of the Inflammatory Skin Diseases Laboratory at the Icahn School of Medicine at Mount Sinai. “It often develops at a very young age, causing the skin to become inflamed, red, extremely itchy, painful and very dry – all symptoms that severely impact a patient’s quality of life. We are very optimistic about the results of this study and the potential for disease modification and long-lasting effects to improve patients’ quality of life.”

In this phase 2b, multicentre, double-blind, placebo-controlled study, 274 patients (rocatinlimab: n=217; placebo: n=57) were randomly assigned to rocatinlimab (150 mg or 600 mg) or every other week (300 mg or 600 mg) or subcutaneous placebo through week 18, with an 18-week extension of active treatment and a 20-week follow-up. This study was conducted at 65 sites in the United States, Canada, Japan and Germany.

Percent change from baseline in Eczema Area and Severity Index (EASI) score was assessed as the primary endpoint at week 16, and significance versus placebo was determined with all active rocatinlimab doses (-48% to -61%) compared to Reached placebo (-15%). All active dose cohorts continued to improve after week 16, and most patients maintained the response for at least 20 weeks without treatment.

The results support rocatinlimab as a safe and effective treatment for moderate to severe atopic dermatitis with potentially long-lasting efficacy and disease modification. The reported side effects were generally similar between the rocatinlimab groups. Common adverse events during the double-blind phase were fever, chills, headache, aphthous ulcers (aphthae) and nausea.

“At week 36, all participants had been on treatment for at least 18 weeks,” added Dr. Guttman, senior author of the study, added. “At that point we saw that while the drug met the primary endpoints at all doses compared to placebo, it is also a drug that improves over time, which is really unusual and unique among the treatment options currently available.”

Researchers plan to continue this investigation in a phase 3 program in 2023. Future studies will also include a larger study population, longer follow-up, and exploring combination therapy (such as rocatinlimab plus topical corticosteroids).

The study is registered on ClinicalTrials.gov (NCT03703102).