Patients with moderate to severe atopic dermatitis who participated in a clinical trial of the novel, patient-tailored monoclonal antibody therapy rocatinlimab showed encouraging results both while taking the medication and for up to 20 weeks after it was stopped, according to Mount Sinai researchers who published their findings in The Lancet.
The researchers’ findings indicate that rocatinlimab may have the power to permanently modify a person’s atopic dermatitis genetics and may even help maintain long-lasting benefits in the absence of continued therapy. Rocatinlimab inhibits the immunological molecule OX40, which is essential for the onset of atopic dermatitis and other inflammatory diseases and is involved in activating inflammatory cells.
“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, MD, PhD, Waldman Professor and System Chair, The Kimberly and Eric J. Waldman Department of Dermatology; Director, Center of Excellence in Eczema; and Director, Laboratory of Inflammatory Skin Diseases, 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 greatly affect a patient’s quality of life. We are very optimistic about the results of this trial and the potential for disease modification and long-lasting effects to improve patients’ quality of life.”
In this phase 2b multicenter, double-blind, placebo-controlled research, 274 patients were enrolled, and (rocatinlimab: n=217; placebo: n=57) randomly allocated 1:1:1:1:1 to subcutaneous placebo up to week 18, with an extension of active therapy for a further 18 weeks, and 20 weeks of follow-up.
65 locations in the United States, Canada, Japan, and Germany participated in this experiment. The main objective was calculated as the percent change from baseline in the Eczema Area and Severity Index (EASI) score at week 16, and all active rocatinlimab dosages (-48 to -61%) achieved significance vs placebo (-15 per cent). After week 16, all active dosage groups kept getting better, and the majority of patients kept their response for at least 20 weeks of therapy.
The findings demonstrate the effectiveness and safety of rocatinlimab as a therapy for mild to moderate atopic dermatitis, with the potential for long-term efficacy and disease modification. The documented adverse effects between rocatinlimab groups were essentially comparable.
During the double-blind period, fever, chills, headaches, aphthous ulcers (canker sores), and nausea were frequent side effects. “At week 36, all participants had been on the treatment for at least 18 weeks,” added Dr Guttman, senior author of the study. “By this time, we saw that while the drug achieved the primary endpoints in all doses versus the placebo, it’s also a drug that improves over time, which is really unusual and unique among currently available treatment options.”
This examination will be continued in a phase 3 programme in 2023, according to the researchers. Future studies will also examine combination treatment and include a bigger research population with longer follow-ups (such as rocatinlimab plus topical corticosteroids).