Patients with moderate to severe atopic dermatitis who participated in a clinical trial of rocatinlimab – a novel, patient-tailored monoclonal antibody therapy – showed promising results both in when taking the drug and for up to 20 weeks after stopping treatment, Mount Sinai researchers reported in Fingertips.
The results indicate that rocatinlimab has the ability to change a person’s genetic makeup, the researchers say. atopic dermatitis long-term and can help maintain long-term results without the need for continued use. Rocatinlimab inhibits OX40, an immune molecule involved in the activation of inflammatory cells plays an important role in the development of atopic and other dermatitis inflammatory disease.
“Atopic dermatitis, the most common type of eczema, is a debilitating chronic inflammatory skin disease that affects 1 in 10 Americans and millions worldwide,” says Emma Guttman, MD, Ph.D. ., Professor Waldman and President of Systems, The Kimberly said. and Eric J. Waldman of Dermatology; Director, Eczema Center of Excellence; and Director, Laboratory of Inflammatory Diseases, at the Icahn School of Medicine at Mount Sinai.
“This disease often develops at a very young age, causing the skin to become inflamed, red, extremely itchy, painful and very dry—all of these symptoms greatly impact a patient’s quality of life. We are optimistic. about the results of this trial and its disease-modifying potential and long-term effects to improve patients’ quality of life.”
In this multicenter, double-blind, placebo-controlled, phase 2b study, 274 patients were enrolled and (rocatinlimab: n=217; placebo: n=57) randomized 1:1: 1:1:1 give rocatinlimab every four weeks (150 mg or 600 mg) or biweekly (300 mg or 600 mg) or placebo subcutaneously until week 18, with a treatment duration of 18 weeks and follow-up for 20 weeks. This trial was performed at 65 sites in the United States, Canada, Japan, and Germany.
Percentage change from baseline in Eczema Aspect and Severity Index (EASI) scores were assessed as the primary endpoint at week 16, and reached significance versus placebo for all rocatinlimab doses were active (-48% to -61%) compared with placebo (-15%). All active-dose cohorts also continued to improve after week 16, and most patients maintained a response 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 long-lasting efficacy and disease-modifying potential. Reported adverse events were generally similar between the rocatinlimab groups. Common side effects during the double-blind period included fever, chills, headache, aphthous ulcers (mouth ulcers), and nausea.
“At week 36, all participants had been treated for at least 18 weeks,” adds Dr. Guttman, lead author of the study. “At this point, we found that while the drug met the key endpoints at all doses compared to placebo, it was also a drug that improved over time, which is really unusual and unique.” among the treatment options available.”
The researchers plan to continue this investigation in the phase 3 program in 2023. Future studies will also include a larger study population, longer follow-up, and discovery of end therapy. combination (such as rocatinlimab plus topical corticosteroids).
Fingertips (2022). DOI: 10.1016/S0140-6736(22)02037-2
Mount Sinai Hospital
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