IL-4/IL-13 inhibitor achieves notable depth and durability of skin clearance in moderate-to-severe AD

Rademikibart produced rapid and clinically meaningful improvements in skin clearance and pruritus in adults and adolescents with moderate-to-severe atopic dermatitis (AD). Moreover, response rates continued to deepen over the course of 1 year of treatment.

Despite the expanding biologic armamentarium for moderate-to-severe AD, there remains clinical interest in agents that combine high efficacy with a tolerability profile that minimises class-typical concerns such as conjunctivitis. The phase 3 RADIANT-AD trial (NCT06477835) was designed to evaluate whether rademikibart, administered every 2 weeks, could meet these expectations in adolescents and adults whose disease was inadequately managed with topical therapy alone [1].

As Prof. Cheng Zhou (Peking University People’s Hospital, China) explained, the randomised, placebo-controlled trial included 2 co-primary endpoints assessed at week 16: the proportion of participants achieving an Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear skin) with a ≥2-point reduction from baseline, and the proportion achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI) 75. At week 16, IGA 0/1 was achieved by 47.4% of patients receiving rademikibart versus 17.6% with placebo, and EASI 75 by 74.2% versus 34.4%, respectively (both P<0.001). Responses continued to deepen over time, reaching 87.1% (IGA 0/1) and 96.6% (EASI 75) at week 52. Both endpoints demonstrated robust separation from placebo.

Pruritus outcomes were similarly favourable. A clinically meaningful improvement of ≥3 points in pruritus score was achieved by 54.7% of rademikibart-treated patients compared with 27.5% receiving placebo at week 16 (P<0.0001), increasing to 91.2% by week 52. Analyses using the more stringent ≥4-point reduction threshold, considered clinically meaningful, showed a consistent and durable treatment effect. Additional patient-reported outcomes and quality-of-life data are expected to be reported at a later stage.

The safety profile through week 16 was comparable to placebo and remained consistent with sustained IL-4/IL-13 inhibition through 1 year. Serious adverse events, treatment discontinuations, and injection-site reactions were infrequent, and no new safety signals emerged over the 52-week period. Notably, conjunctivitis occurred in 3.9% of rademikibart-treated patients versus 3.1% in the placebo group. Most adverse events were mild to moderate in severity.

Zhou C, et al. Rademikibart monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis (AD): A 1-year, phase III, randomized, double-blinded, placebo-controlled trial (RADIANT-AD). S023: Late-Breaking Research: Session 1. AAD 2026, 27–31 March, Denver, CO, USA.