Baseline Characteristics of Patients with Asthma and Prior Oral Systemic Corticosteroid Use Initiating Dupilumab in a Real-World Registry (RAPID)

Speaker(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, Reed C7, Soler X5
1University of Michigan, Ann Arbor, MI, USA, 2Humanitas University & IRCCS Humanitas Research Hospital & Humanitas Medical Care, 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

Presentation Documents

OBJECTIVES: To characterize patients with asthma and prior oral corticosteroid (OCS) use initiating dupilumab in a real-world setting.

METHODS: Baseline characteristics of patients enrolled in RAPID ((NCT04287621), a prospective, observational registry) during a 6-month period were analysed: baseline treatments (systemic corticosteroid [SCS] and OCS use), disease characteristics including pre-bronchodilator spirometry values (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC], peak expiratory flow [PEF]), fractional exhaled nitric oxide [FeNO], and the 6-item asthma control questionnaire (ACQ-6) score.

RESULTS: Of the initial 205 patients enrolled, 58 (28%) had used systemic corticosteroids (SCS) in the 3 months prior. Of these 58 patients: 52/58 (90%) used OCS in the 3 months prior; 21/52 (40%) used OCS at 6 months; 65% were female; 67% were White. Mean (SD) age was 48.8 (16.8) years; mean (SD) BMI was 31.65 (8.8) kg/m2, with 21% <25 kg/m2, 19% 25–<30 kg/m2, and 54% ≥30 kg/m2. Pre-bronchodilator spirometry values were — FEV1: 2.3 (1.5) L; percent predicted (pp) FEV1: 66.6% (21.4); FVC: 2.9 (1.1) L; ppFVC: 80.7% (20.2); PEF: 368 (204) L/min; ppFEF25-75%: 45.3% (26.7). 12/15 patients had baseline blood eosinophils ≥150 cells/mL and 17/22 had baseline FeNO ≥25 ppb. Mean (SD) ACQ-6 score was 2.8 (1.4). Baseline characteristics were similar to those of the overall population (N=205).

CONCLUSIONS: In this interim analysis from RAPID, 52/205 (≥25%) of patients had recently used or were currently using OCS, indicating a high unmet need in this asthma population.

Code

CO174

Topic

Study Approaches

Topic Subcategory

Prospective Observational Studies, Registries

Disease

No Additional Disease & Conditions/Specialized Treatment Areas, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)