A monoclonal antibody drug known as rocatinlimab produced potentially long-term symptom relief in patients with moderate to severe atopic dermatitis. The corresponding study was published in The Lancet.
"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," Emma Guttman, MD, PhD, Waldman Professor and System Chair, The Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, one of the authors of the study, said in a press release.
"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,” she added.
The body naturally produces proteins known as antibodies in response to and to counteract foreign or toxic substances known as antigens. Researchers can design antibodies to target specific antigens in the lab. These are known as monoclonal antibodies and have been used to treat conditions from cancer to COVID-19.
In the current study, the researchers conducted a double-blind, placebo-controlled phase 2b trial at 65 sites across the US, Canada, Japan, and Germany. They enrolled 274 patients aged 18 and older who had moderate to severe atopic dermatitis that affected 10% of more of the skin. The patients also had a history of inadequate response to other treatments.
During the trial, the patients received various doses of subcutaneous rocatinlimab or a placebo every two or four weeks for 18- 36 weeks. The patients were followed for 20 weeks after treatment, and were assessed using the Eczema area and Severity Index.
Mean symptom reductions for those on 150mg rocatinlimab were 43.9%, whereas those on 300-600mg experienced larger reductions of 59.4- 65.2%. Meanwhile, those in the placebo group saw their symptoms reduce by 16.7%. The researchers noted that the results remained for at least 20 weeks following treatment.
Overall, rocatinlimab was generally well-tolerated. However, common side effects reported by patients included pyrexia- raised body temperature or fever, inflammation in the pharynx and nasal cavities, chills, and headache.
The researchers now hope to continue investigating the drug in a phase 3 program in 2023. Future studies will include larger cohorts, with longer follow-up periods, and will also explore combination therapies, such as rocatinlimab alongside topical corticosteroids.
Sources: Science Daily, The Lancet