CALIFORNIA: According to Mount Sinai researchers who published their findings in The Lancet, patients with moderate to severe dermatitis">atopic dermatitis who took part 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.
The findings, according to the researchers, suggest that rocatinlimab may have the capacity to permanently alter the genetics of an individual's dermatitis">atopic dermatitis and may even contribute to the maintenance of long-lasting effects in the absence of ongoing treatment.
The immunological molecule OX40, which is involved in activating inflammatory cells and is crucial for the emergence of dermatitis">atopic dermatitis and other inflammatory illnesses, is inhibited by rocatinlimab.
"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 study, 274 patients were recruited and (rocatinlimab: n=217; placebo: n=57) randomly assigned 1:1:1:1:1 to rocatinlimab every four weeks (150 mg or 600 mg) or every two weeks (300 mg or 600 mg) or subcutaneous placebo up to week 18, with an 18-week active-treatment extension and 20-week follow-up.
This trial was conducted at 65 sites within the United States, Canada, Japan, and Germany. Per cent change from baseline in the Eczema Area and Severity Index (EASI) score was assessed as the primary endpoint at week 16, and significance versus placebo was achieved with all active rocatinlimab doses (-48 per cent to -61 per cent) doses compared to placebo (-15 per cent).
All active dose cohorts also continued improving after week 16, and most patients maintained the response for at least 20 weeks of treatment.
The results support rocatinlimab as a safe and effective treatment for moderate to severe dermatitis">atopic dermatitis, with potentially long-lasting efficacy and disease modification.
Adverse events reported were generally similar between rocatinlimab groups. Common adverse events during the double-blind period included fever, chills, headache, aphthous ulcers (canker sores), and nausea. "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."
Researchers plan to continue this investigation in a phase 3 program in 2023. Future studies will also include a larger study population, longer follow-ups, and exploration of combination therapy (such as rocatinlimab plus topical corticosteroids).