Safety and Efficacy of Dupilumab in Adults and Adolescents With Asthma in the RAPID Registry

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Abstract RATIONALE: Dupilumab is a human monoclonal antibody that blocks interleukins 4 and 13, which are key and central drivers of type 2 inflammation in asthma. Dupilumab has proven efficacy and safety for the treatment of moderate-to-severe asthma in clinical trials, but real-world data are sparse. RAPID (NCT04287621) is a global, prospective registry characterizing patients with asthma who initiate dupilumab in real-world clinical practice. METHODS: RAPID enrolled 719 patients aged ≥12 years initiating dupilumab for asthma according to country-specific prescribing information. This analysis included the first 205 patients who completed 12 months in the study. Here, we report the unadjusted annualized severe exacerbation rate, asthma control assessed using the 6-item Asthma Control Questionnaire (ACQ-6; ranging from 0 = totally controlled, to 6 = severely uncontrolled), quality of life assessed by the Mini Asthma Quality of Life Questionnaire (Mini-AQLQ; ranging from 1 = worst quality of life, to 7 = best quality of life), and treatment-emergent adverse events (TEAEs) by Preferred Term. RESULTS: The mean (standard deviation [SD]) age of the 205 patients was 50.1 (17.4) years, and 134 (65.4%) were female. Patients experienced a mean (SD) of 1.9 (4.2) severe asthma exacerbations in the year before screening (Table). After 12 months in the study, the unadjusted severe asthma exacerbation rate was 0.14 (Table). Mean (SD) ACQ-6 score improved from 2.3 (1.2) at baseline to 1.1 (1.0) at Month 6 and 1.0 (1.1) at Month 12 (Table). Mini-AQLQ score improved from 4.1 (1.3) at baseline to 5.5 (1.3) at Month 6 and 5.5 (1.4) at Month 12 (Table). ACQ-6 and Mini-AQLQ changes from baseline are shown in the Table. TEAEs were reported by 99 patients (48.3%): most commonly asthma (11.7%), COVID-19 (5.9%), acute sinusitis (4.9%), arthralgia (2.0%), headache (2.0%), pneumonia (2.0%), sinusitis (2.0%), and upper respiratory tract infection (2.0%). CONCLUSIONS: Patients who initiated dupilumab in the RAPID registry and completed the first 12 months had significantly reduced severe asthma exacerbation rates and improved asthma control and quality of life. Tolerability was consistent with the known safety profile of dupilumab in adults and adolescents.These data confirm the effectiveness and safety of dupilumab in a real-world clinical setting.

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