Abstract Rationale Dupilumab, a human monoclonal antibody, blocks signaling of IL-4/13, key and central drivers of type 2 inflammation. Numerous randomized controlled trials have demonstrated the efficacy and safety of dupilumab in uncontrolled, moderate-to-severe asthma, however more evidence is needed to understand the effectiveness and safety of dupilumab for asthma in real-world settings for certain higher risk populations, including Puerto Rican (PR)-Hispanic patients. This analysis characterizes PR-Hispanic, non-PR-Hispanic, and non-Hispanic patients with asthma and evaluates the effectiveness of dupilumab in these subgroups during the first 12 months of the RAPID asthma registry. Methods The Registry of Asthma Patients Initiating DUPIXENT® (RAPID; NCT04287621) is a global, prospective, observational registry of patients aged ≥12 years with asthma initiating dupilumab in clinical practice. For this interim analysis, baseline demographics and disease characteristics, effectiveness analyses at 12 months (unadjusted annualized severe exacerbations; 6-Item Asthma Control Questionnaire ACQ-6 responders improvement from baseline ≥0.5, and safety were evaluated in PR-Hispanic, non-PR-Hispanic, and non-Hispanic subgroups, in the full enrolled population. Results Data from 665 patients were analyzed (PR-Hispanic, n = 41; non-PR-Hispanic, n = 91; non-Hispanic, n = 533; this subgroup order is used to present data throughout the results); 54 patients were excluded due to unknown/unreported ethnicity. Mean (SD) age was 59.3 (13.7), 46.8 (20.5), and 41.9 (18.2) years in PR-Hispanic, non-PR-Hispanic, and non-Hispanic patients, respectively; 68.3%, 73.6%, and 63.2% were female. At baseline, the mean (SD) pre-bronchodilator percent predicted (pp) forced expiratory volume in 1 second (FEV1) was 70.8% (24.3), 80.5% (24.0), and 76.6% (23.0); mean (SD) number of severe exacerbations in the year prior to screening was 1.5 (2.7), 1.9 (2.5), and 2.3 (3.4); and mean (SD) ACQ-6 score was 2.8 (1.2), 2.7 (1.3), and 2.3 (1.2). After 12 months, PR-Hispanic, non-PR-Hispanic, and non-Hispanic patients had unadjusted annualized severe exacerbation rates of 0.054, 0.069, and 0.275. Only 4.9%, 4.4% and 14.9% experienced ≥1 severe exacerbation during the study. At 1 year of treatment, the proportion of PR-Hispanic, non-PR-Hispanic, and non-Hispanic patients who achieved a ≥ 0.5-point improvement in ACQ-6 total score was 70.0% (14/20), 85.0% (34/40), and 75.7% (227/300). Adverse events leading to permanent treatment discontinuation were reported in 2.4%, 4.7%, and 3.4%. Conclusions Dupilumab was effective and had an acceptable safety profile in PR-Hispanic, non-PR-Hispanic and non-Hispanic patients with asthma completing the first year of the RAPID registry. The safety profile was consistent with the known dupilumab safety profile. This abstract is funded by: oResearch sponsored by Sanofi and Regeneron Pharmaceuticals, Inc.
Cote et al. (Fri,) studied this question.
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