Characteristics at Baseline of Patients with Asthma and Prior Systemic Corticosteroid Use Initiating Dupilumab Enrolled in the Real-World Study Rapid
Author(s)
Lugogo NL1, Heffler E2, Plaza V3, Hilberg O4, Xia C5, Nash S5, Pandit-Abid N6, Jacob-Nara JA6, Sacks H5, Rowe PJ6, Deniz Y5, Hardin M7, Ledanois O8, Soler X5
1University of Michigan, Ann Arbor, MI, USA, 2Humanitas University, IRCCS Humanitas Research Hospital, Milan, Italy, 3Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, 4Lillebaelt Hospital, Vejle, Denmark, 5Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA, 6Sanofi, Bridgewater, NJ, USA, 7Sanofi, Cambridge, MA, USA, 8Sanofi, Paris, France
Presentation Documents
OBJECTIVES: The use of systemic corticosteroids (SCS), including oral corticosteroids (OCS) is a common therapeutic option in acute asthma and its maintenance management. RAPID (NCT04287621) is a global, prospective registry that aims to characterize patients with asthma initiating dupilumab in real-world clinical practice. This analysis reports baseline characteristics of patients enrolled in RAPID, with focus on SCS use.
METHODS: RAPID is enrolling patients aged ≥12 years who initiate dupilumab for asthma (primary indication) according to country-specific prescribing information.
RESULTS: Between Mar 6, 2020 and Oct 28, 2021, 205 patients were enrolled. 54/205 pts (26%) had received SCS in the 3 months prior. Of these, 52 (96%) reported having used OCS medications specifically within this time. OCS use was ongoing for 25/52 patients (48%) at the time of enrolment. Mean (SD) age was 48.0 (17.2) years, 35 patients (65%) were female, and 37 (69%) were White. Mean (SD) pre-bronchodilator FEV1 was 2.3 (1.5) L (n=32/54), mean (SD) pre-bronchodilator percent predicted FEV1 was 66.3 (21)% (n=38/54), mean (SD) forced vital capacity (FVC) was 2.9 (1.1) L (n=32/54), percent predicted FVC was 80.3 (20)% (n=35/54), mean (SD) peak expiratory flow rate was 368.9 (190.5) L (n=15/54), and the mean (SD) percent predicted forced expiratory flow between 25 and 75% of vital capacity (FEF25-75) was 45 (26)% (n=32/54). 13/16 patients (81%) had baseline blood eosinophil counts of ≥150 cells/mL and 17/22 (77%) patients had baseline FeNO levels ≥25 ppb. Mean (SD) ACQ-6 score was 2.7 (1.4) (n=51/54). Baseline demographics and clinical characteristics at baseline were similar to the overall population (N=205).
CONCLUSIONS: In this initial presentation of baseline characteristics of patients from RAPID, initiating dupilumab for asthma, we show that ≥ 25% of patients were currently or had recently received SCS, indicating a high unmet need in this population.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
PCR200
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Clinical Outcomes Assessment, Clinical Trials, Registries
Disease
Biologics & Biosimilars, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)