Patients maintained significant improvement up to 20 weeks after stopping the drugs.
Patients with moderate to severe atopic dermatitis who participated in a clinical study of Rocatinlimab – a new patient-tailored monoclonal antibody therapy – showed promising results both while taking the drug and up to 20 weeks after stopping therapy, Mount Sinai researchers reported in The Lancet.
According to the researchers, the findings indicate that rocatinlimab has the potential to change the genetic makeup of a person’s atopic dermatitis in the long term, and possibly help maintain long-lasting results without continued use . 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 1 in 10 Americans and millions of people worldwide,” said Emma Guttman, Ph.D., of Icahn’s Laboratory of Inflammatory Skin Diseases. Mount Sinai School of Medicine. “Often it develops at a very young age and the skin becomes inflamed, red, extremely itchy, painful and very dry, all of which significantly affect a patient’s quality of life. We are very optimistic about the results of this study and the potential for disease-modifying and lasting effects to improve patients’ quality of life.”
In this study, 274 patients were recruited: 217 treated with rocatinlimab and 57 treated with placebo. Rocatinlimab was administered every four weeks (150 mg or 600 mg) or every two weeks (300 mg or 600 mg) through week 18 and a 20-week follow-up. The study was conducted at 65 sites in the United States, Canada, Japan and Germany.
The percent change in Eczema Area and Severity Index (EASI) score was achieved with all active doses of rocatinlimab (-48% to -61%) versus placebo (-15%). All patients receiving the drug continued to improve after week 16, and most patients maintained responses for at least 20 weeks off treatment. Reported adverse events were generally similar between rocatinlimab groups. The most common included fever, chills, headache, canker sores, and nausea.
“By week 36, all participants had been on treatment for at least 18 weeks,” added Dr. Guttman, senior author of the study. “At this point, we’ve seen that the drug has met the primary endpoints across all doses compared to placebo, but it’s also a drug that gets better over time, which is very unusual and unique among currently available treatment options.”
The investigators 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 exploration of combination therapy (such as rocatinlimab plus topical corticosteroids).
- An anti- OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study (thelancet.com)