The following is a summary of “Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4Rα, in adults with moderate to severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001),” published in the April 2024 issue of Allergy & Immunology by Silverberg, et al.
Rademikibart (CBP-201), a novel IL-4 receptor alpha–targeting antibody, was assessed in adults with moderate to severe atopic dermatitis. In this randomized, double-blind trial, 226 patients were assigned to receive subcutaneous rademikibart at doses of 300 mg every 2 weeks (Q2W), 150 mg Q2W, or 300 mg every 4 weeks (Q4W), with a 600-mg loading dose, or placebo. The trial commenced in July 2020 and concluded in October 2021.
Results revealed that rademikibart achieved its primary endpoint, demonstrating a significant reduction from baseline in least-squares mean Eczema Area Severity Index (EASI) scores by week 16: 300 mg Q2W (-63.0%; P = .0007), 150 mg Q2W (-57.6%; P = .0067), and 300 mg Q4W (-63.5%; P = .0004), compared to placebo (-39.7%). EASI scores significantly decreased with 300 mg Q2W and Q4W dosing as early as week 2, with sustained improvement through week 16. Significant enhancements were also observed in secondary endpoints, including pruritus.
Across primary and secondary endpoints, efficacy appeared comparable between the 300 mg Q2W and Q4W dosing regimens. Furthermore, rademikibart and placebo exhibited similar, low incidence rates of treatment-emergent adverse events (TEAEs) (48% vs. 54%), serious TEAEs (1.8% vs. 3.6%), TEAEs leading to treatment discontinuation (1.2% vs. 1.8%), conjunctivitis of unspecified cause (2.9% vs. 0%), herpes (0.6% vs. 1.8%), and injection-site reactions (1.8% vs. 1.8%). While no discontinuations were attributed to coronavirus disease 2019, pandemic-related restrictions may have affected trial conduct.
In conclusion, rademikibart demonstrated efficacy and tolerability at both Q2W and Q4W dosing intervals, offering a more convenient frequency than current therapies.
Reference: sciencedirect.com/science/article/abs/pii/S0091674923025460
