Rademikibart for Asthma With Type 2 Biomarkers: Exploratory Subgroup Analyses From a Phase 2b Randomized Clinical Trial
In brief
Rademikibart raised lung function by 519 mL in biomarker-high asthma
In this exploratory analysis of a phase 2b trial, adults with both high eosinophils and high exhaled nitric oxide had a 519 mL greater lung-function improvement than placebo at 24 weeks on the 300 mg dose. Exacerbations fell by at least 63% across the studied subgroups, but these post hoc findings need confirmation in larger trials.
- Journal
- Allergy (Q1)
- Published
- 9 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Michael E Wechsler, Praveen Akuthota, Barry Quart, Raúl Collazo
- PMID
- 42717393
- DOI
- 10.1111/all.70506
Why clinicians should know about it
- Picked for Immunology and Allergy (top studies of the week, 25 October 2026): Rademikibart improves lung function in type‑2 asthma
- Picked for Pulmonary and Respiratory Medicine (top studies of the week, 11 October 2026): Rademikibart improves lung function in type‑2 high asthma
Abstract
BACKGROUND: Rademikibart, an IL-4Rα-targeting antibody, demonstrated efficacy in a Phase 2b trial of adults with moderate-to-severe uncontrolled asthma (NCT04773678). We report exploratory and predominantly post hoc subgroup analyses, according to baseline eosinophil count (EOS) and fractional exhaled nitric oxide (FeNO). METHODS: Patients were randomized, double-blind, to rademikibart 150 mg or 300 mg Q2W (600-mg loading) or placebo, with medium-to-high dose inhaled corticosteroids and ≥ 1 reliever/controller. Up to eight EOS/FeNO subgroups were investigated, focusing on the following five: ≥ 300 cells/μL and ≥ 25 ppb (N = 80); ≥ 25 ppb (N = 142); ≥ 300 cells/μL (N = 129); ≥ 150 cells/μL (N = 247); 150- < 300 cells/μL (N = 118). RESULTS: Prebronchodilator FEV1 increased significantly at first assessment (Week 1) and was sustained throughout the 24-week treatment period. FEV1 and asthma control (ACQ-6) improvements were greatest when baseline EOS and FeNO were both elevated. At Week 1, after a 600-mg loading dose, placebo-adjusted FEV1 increased by 422 mL (≥ 300 cells/μL and ≥ 25 ppb), 339 mL (≥ 25 ppb), 324 mL (≥ 300 cells/μL), 227 mL (≥ 150 cells/μL), and 141 mL (150- < 300 cells/μL). At Week 24, with 300 mg Q2W, placebo-adjusted FEV1 increased by 519 mL (≥ 300 cells/μL and ≥ 25 ppb), 401 mL (≥ 25 ppb), 394 mL (≥ 300 cells/μL), 287 mL (≥ 150 cells/μL), and 159 mL (150- < 300 cells/μL). Exacerbations decreased by ≥ 63% per subgroup. Rademikibart was well tolerated. No eosinophilia (Preferred Term) was reported. Grade 1 eosinophil count increased did not lead to treatment discontinuation (n = 2). CONCLUSIONS: Rapid and sustained improvements were more pronounced in patients with type 2-high biomarkers than previously reported in the overall study population.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.