Rocatinlimab, an OX40 inhibitor, continues to provide results in patients with moderate to severe atopic dermatitis (AD) even after the therapy is stopped, according to the results of a study published in The Lancet. The researchers report the monoclonal, patient-tailored therapy was effective in patients during the clinical trial and for up to 20 weeks after cessation of therapy.
The OX40 pathway is involved in activating inflammatory cells that play a key role in the development of atopic dermatitis and other inflammatory diseases, the researchers report. This international study included 65 sites in the U.S., Canada, Japan, and Germany.
The phase 2b multicentre, double-blind, placebo-controlled study assessed 274 patients (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.
Week 16 was the primary endpoint when the per cent change from baseline was assessed using the Eczema Area and Severity Index (EASI) score. The authors report that significance was achieved with all active rocatinlimab doses (-48% to -61%) compared to placebo (-15 %). They noted that all patients who received rocatinlimab continued to show improvement after week 16, with most patients showing response for at least 20 weeks after treatment.
The authors reported that adverse events for all doses of rocatinlimab were generally similar, including fever, chills, headache, aphthous ulcers, and nausea.
"At week 36, all participants had been on the treatment for at least 18 weeks," added Emma Guttman, MD, PhD, senior author of the study in a press release. "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." She is 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 in New York City.