TWELVE-MONTH REAL-WORLD OUTCOMES WITH DUPILUMAB IN HISPANIC AND NON-HISPANIC PATIENTS WITH ASTHMA: RESULTS FROM RAPID
Author(s)
Andréanne Côté, MD1, Ole Hilberg, MD2, Allison C. Ramsey, MD3, Arnaud Bourdin, MD4, Enrico Heffler, MD, PhD5, Adel H. Mansur, Prof.6, Caresse Campbell, PhD, MPH7, Changming Xia, PhD8, Hashem Awad, MD7, Rebecca Gall, MD8, Anju T Peters, MD9;
1Quebec Heart and Lung Institute – Laval University, Quebec City, QC, Canada, 2Lillebaelt Hospital, Vejle, Denmark, 3Rochester Regional Health, Rochester, NY, USA, 4PhyMedExp, University of Montpellier, Montpellier, France, 5IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy, 6University of Birmingham, Birmingham, United Kingdom, 7Sanofi, Cambridge, MA, USA, 8Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA, 9Northwestern University Feinberg School of Medicine, Chicago, IL, USA
1Quebec Heart and Lung Institute – Laval University, Quebec City, QC, Canada, 2Lillebaelt Hospital, Vejle, Denmark, 3Rochester Regional Health, Rochester, NY, USA, 4PhyMedExp, University of Montpellier, Montpellier, France, 5IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy, 6University of Birmingham, Birmingham, United Kingdom, 7Sanofi, Cambridge, MA, USA, 8Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA, 9Northwestern University Feinberg School of Medicine, Chicago, IL, USA
OBJECTIVES: Dupilumab, a human monoclonal antibody that blocks signaling of interleukin-4/13, has demonstrated efficacy and safety in uncontrolled, moderate-to-severe asthma in numerous randomized controlled trials. This analysis evaluated baseline characteristics and 12-month outcomes in Puerto Rican (PR)-Hispanic, non-PR-Hispanic, and non-Hispanic patients in the RAPID asthma registry.
METHODS: The Registry of Asthma Patients Initiating DUPIXENT® (RAPID; NCT04287621) is a global, prospective registry of patients aged ≥12 years with asthma initiating dupilumab. This interim analysis assessed baseline characteristics, effectiveness analyses at 12 months (unadjusted annualized severe exacerbations; Mini Asthma Quality of Life Questionnaire [MiniAQLQ] responders [≥0.5-point improvement from baseline]), and safety in PR-Hispanic, non-PR-Hispanic, and non-Hispanic subgroups.
RESULTS: Data from 665 patients were analyzed (PR-Hispanic, n=41; non-PR-Hispanic, n=91; non-Hispanic, n=533). The order of data presented are for PR-Hispanic, non-PR-Hispanic, and non-Hispanic patients, respectively. Mean (SD) age was 59.3 (13.7), 46.8 (20.5), and 49.1 (18.2) years; 68.3%, 73.6%, and 63.2% were female patients. Mean (SD) baseline pre-bronchodilator percent predicted forced expiratory volume in 1 second was 70.8% (24.3), 80.5% (24.0), and 76.6% (23.0); 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 MiniAQLQ scores were 3.4 (1.3), 3.7 (1.4), and 4.2 (1.3). After 12 months, unadjusted annualized severe exacerbation rates were 0.052, 0.110, and 0.292. Percentages of patients who experienced ≥1 severe exacerbation were 4.9%, 6.6 %, and 18.9%. After 1 year in the study, MiniAQLQ responder rates were 79.2% (19/24), 84.6% (33/39), and 69.8% (213/305). Adverse events leading to permanent treatment discontinuation were reported in 2.4%, 4.4%, and 4.1%.
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.
METHODS: The Registry of Asthma Patients Initiating DUPIXENT® (RAPID; NCT04287621) is a global, prospective registry of patients aged ≥12 years with asthma initiating dupilumab. This interim analysis assessed baseline characteristics, effectiveness analyses at 12 months (unadjusted annualized severe exacerbations; Mini Asthma Quality of Life Questionnaire [MiniAQLQ] responders [≥0.5-point improvement from baseline]), and safety in PR-Hispanic, non-PR-Hispanic, and non-Hispanic subgroups.
RESULTS: Data from 665 patients were analyzed (PR-Hispanic, n=41; non-PR-Hispanic, n=91; non-Hispanic, n=533). The order of data presented are for PR-Hispanic, non-PR-Hispanic, and non-Hispanic patients, respectively. Mean (SD) age was 59.3 (13.7), 46.8 (20.5), and 49.1 (18.2) years; 68.3%, 73.6%, and 63.2% were female patients. Mean (SD) baseline pre-bronchodilator percent predicted forced expiratory volume in 1 second was 70.8% (24.3), 80.5% (24.0), and 76.6% (23.0); 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 MiniAQLQ scores were 3.4 (1.3), 3.7 (1.4), and 4.2 (1.3). After 12 months, unadjusted annualized severe exacerbation rates were 0.052, 0.110, and 0.292. Percentages of patients who experienced ≥1 severe exacerbation were 4.9%, 6.6 %, and 18.9%. After 1 year in the study, MiniAQLQ responder rates were 79.2% (19/24), 84.6% (33/39), and 69.8% (213/305). Adverse events leading to permanent treatment discontinuation were reported in 2.4%, 4.4%, and 4.1%.
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.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
SA9
Topic
Study Approaches
Topic Subcategory
Registries
Disease
SDC: Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory), STA: Biologics & Biosimilars