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J Allergy Clin Immunol. 2023 Feb 3:S0091-6749(23)00144-6. doi: 10.1016/j.jaci.2023.01.020. Online ahead of print.


BACKGROUND: Multiple monoclonal antibodies are currently approved for the treatment of asthma. However, there is limited evidence on their comparative effectiveness.

OBJECTIVE: To compare the effectiveness of omalizumab, mepolizumab, and dupilumab in individuals with moderate to severe asthma.

METHODS: We emulated a hypothetical randomized trial using electronic health records from a large US-based academic health care system. Participants aged ≥18 years with baseline immunoglobulin E levels between 30 and 700 IU/ml and peripheral eosinophil counts of ≥ 150 cells/microliter were eligible for study inclusion. The study period was March 2016 to August 2021. Outcomes included the incidence of asthma-related exacerbations and change in baseline forced expiratory volume in one second (FEV1) over 12 months of follow up.

RESULTS: Sixty-eight individuals on dupilumab, 68 on omalizumab, and 65 on mepolizumab met inclusion criteria. Over 12 months of follow-up, 31 exacerbations occurred over 68 person-years (0.46 exacerbations per person-year) in the dupilumab group, 63 over 68 person-years (0.93 per person-year) in the omalizumab group, and 86 over 65 person-years (1.32 per person-year) in the mepolizumab group (adjusted incidence rate ratios: dupilumab vs. mepolizumab 0.28, 95% confidence interval [CI] 0.09 – 0.84; dupilumab vs. omalizumab (0.36, CI 0.12-1.09); omalizumab vs. mepolizumab (0.78, CI 0.32-1.91). The difference in FEV1 change comparing patients receiving dupilumab to those receiving mepolizumab was 0.11 (CI -0.003 to 0.222) L, 0.082 (CI -0.040 to 0.204) L for dupilumab vs. omalizumab, and 0.026 (CI -0.083 to 0.140) L omalizumab vs. mepolizumab.

CONCLUSIONS: Among patients with asthma and eosinophil counts of ≥150 cells/microliter and IgE levels of 30-700 kU/L, dupilumab was associated with greater improvements in exacerbation and FEV1 than omalizumab and mepolizumab.

PMID:36740144 DOI:10.1016/j.jaci.2023.01.020