Significant improvements seen in coprimary end points of EASI-75 response and vIGA-AD score of 0 or 1 versus placebo
FRIDAY, Dec. 5, 2025 (HealthDay News) — For adults with atopic dermatitis, rocatinlimab treatment yields significant improvements across clinical end points, according to a study published online Nov. 25 in The Lancet.
Emma Guttman-Yassky, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues performed two global phase 3 studies to assess the efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in adults (ROCKET-IGNITE [IGNITE] and ROCKET-HORIZON [HORIZON]). In IGNITE, patients were randomly assigned to receive subcutaneous 300-mg rocatinlimab, 150-mg rocatinlimab, or placebo (328, 217, and 222, respectively), while in HORIZON, patients were randomly assigned to receive subcutaneous 300-mg rocatinlimab or placebo (543 and 183, respectively).
The researchers found that both trials met their coprimary end points at week 24 (Eczema Area and Severity Index [EASI]-75 response [≥75 percent improvement in EASI score from baseline] and validated Investigator”s Global Assessment for Atopic Dermatitis [vIGA-AD] score of 0 or 1). In IGNITE and HORIZON, rocatinlimab treatment resulted in significant improvements in EASI-75 response versus placebo at week 24 (42 versus 36 versus 13 percent in IGNITE; 33 versus 14 percent in HORIZON). For vIGA-AD score of 0 or 1 response at week 24, significant improvements were seen with rocatinlimab versus placebo in IGNITE (24 versus 19 versus 9 percent) and HORIZON (19 versus 7 percent). In both IGNITE and HORIZON, the incidences of treatment-emergent adverse events were generally similar across the groups.
“By targeting memory T cells through OX40, rocatinlimab not only clears the skin and relieves itch, but continues to improve patients” lives over time with a strong safety profile,” Guttman-Yassky said in a statement.
Several authors disclosed ties to biopharmaceutical companies, including Amgen and Kyowa Kirin, which funded the study.
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