New drug effective, safe in long-term treatment of moderate to severe atopic dermatitis
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Patients with moderate to severe atopic dermatitis showed promising results during and up to 20 weeks after treatment in a clinical trial evaluating rocatinlimab, according to a study.
“I think [rocatinlimab] will be the next huge, big advance,” Emma Guttman-Yassky, MD, PhD, the Waldman Professor and System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, told Healio. “Besides the fact that all doses showed significance compared to placebo in primary and secondary endpoints ... this drug targets memory T-cells, including memory type 2 T-cells, which means there is thought that this drug may cause disease modification.”
This phase 2b multicenter, double-blind, placebo-controlled study included 274 adults with moderate to severe atopic dermatitis. Participants were randomly assigned to subcutaneous rocatinlimab 150 mg or 600 mg every 4 weeks; rocatinlimab 300 mg or 600 mg every 2 weeks; or subcutaneous placebo up to week 18. Additionally, there was an 18-week active-treatment extension and 20-week follow-up.
Patients taking rocatinlimab saw significantly greater least-squares mean percent change in EASI score from baseline (150 mg every 4 weeks, –48.3; 95% CI, –62.2 to –34; 600 mg every 4 weeks, –49.7; 95% CI, –64.3 to –35.2; 300 mg every 2 weeks, –61.1; 95% CI, –75.2 to –47; 600 mg every 2 weeks, –57.4; –71.3 to –43.4) compared with placebo (–15, 95% CI, –28.6 to –1.4).
Improvements in disease severity observed at week 16 continued through the extension period to week 36. The majority of those in the rocatinlimab groups with EASI 75 response rates (150 mg every 4 weeks, 44%; 600 mg every 4 weeks, 40%; 300 mg every 2 weeks, 54%; 600 mg every 2 weeks, 39%) maintained rates during off-drug follow-up. Additionally, of patients in the rocatinlimab groups with EASI 75 at week 36, the probability of not relapsing at week 56 ranged from 73% to 96%, which Guttman-Yassky emphasized as being “truly amazing, because no other drug right now shows this.”
Adverse events were similar among rocatinlimab groups, the most common being pyrexia (17%), nasopharyngitis (14%), chills (11%), headache (9%) aphthous ulcer (7%) and nausea (6%).
“Our phase 3 trial in 2023 will include adolescents,” Guttman-Yassky said. “If the study pans out, we may be able to treat children early enough to prevent the development of asthma and, potentially, the entire atopic march.”
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