Abstract
BackgroundUp to 58% of patients with severe asthma still have uncontrolled symptoms, despite receiving recommended treatment. Dupilumab is a human monoclonal antibody that blocks interleukin (IL)-4 and IL-13, key and central drivers of type 2 inflammation. In phase 3 QUEST (NCT02414854), add-on dupilumab vs placebo significantly reduced exacerbations and improved pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) in patients with uncontrolled, moderate-to-severe asthma and elevated type 2 biomarkers (baseline blood eosinophils or fractional exhaled nitric oxide [FeNO]). Dupilumab was generally well tolerated. RAPID (NCT04287621) is a global, prospective registry aimed at characterizing patients with asthma initiating dupilumab therapy in real-world clinical practice, including demographics, asthma control, lung function, and disease severity. We report baseline characteristics of patients enrolled during the first 6 months.MethodsThe RAPID registry enrols patients aged ≥12 years who initiate dupilumab treatment for the primary indication of asthma according to country-specific prescribing information. Signed consent was obtained (for minors, from parent or legal guardian).ResultsDuring the first 6 months, 205 patients were enrolled. Baseline characteristics included: mean age 50.10 years (±17.41); female (65.4%); body mass index 30.67 (±7.96); 74.1% were White (including individuals of Hispanic origin) and 13.2% were Black or African-American (table 1). 86.8% had moderate-to-severe disease – according to GINA steps 3 to 5, while 6.3% were GINA 1/2. 24.4% were current or former smokers. Patients had 4.10 (±6.30) severe asthma exacerbations in the previous year. Baseline lung function was: pre-BD FEV1, 2.29 L (±1.14) and pre-BD percent predicted FEV1, 70.34% (±20.30). The 6-„item Asthma Control Questionnaire score was 2.40 (±1.18) and Asthma Quality-of-Life Questionnaire score was 4.10 (±1.31). In the year before enrolment, 9.3% and 18.5% of patients were hospitalized or visited the emergency room due to asthma, respectively. FeNO was 42.2 ppb (±34.83).Abstract S128 Table 1Baseline characteristics of patients enrolled in RAPID (n = 205) Baseline characteristics Population (n = 205) Demographics Age, mean ± SD, years 50.1 ± 17.41 Female, n (%) 134 (65.4) Race, n (%) White 152 (74.1) Black or African-American 27 (13.2) Asian 2 (1.0) Multiple 2 (1.0) Other 6 (2.9) Not reported 15 (7.3) Missing 1 (0.5) BMI, mean ± SD, kg/m2 (n = 194) 30.7 ± 8.0 Smoking history, n (%) Current 9 (4.4) Former 41 (20.0) Age of asthma onset, years, n (%) <18 73 (35.6) ≥18 to ≤40 54 (26.3) >40 78 (38.0) Global Initiative for Asthma (GINA) severity score, n (%) 1 5 (2.4) 2 8 (3.9) 3 29 (14.1) 4 49 (23.9) 5 100 (48.8) Missing score 14 (6.8) Disease characteristics Severe asthma exacerbationsin the year prior to the screening visit, mean ± SD (n=84) 4.10 ± 6.30 Pre-BD FEV1, mean ± SD, L (n = 89) 2.29 ± 1.14 Percent predicted pre-BD FEV1, mean ± SD,% (n = 100) 70.34 ± 20.30 Forced vital capacity, L (n = 89) 3.09 ± 1.08 Peak expiratory flow, L/min (n = 68) 356.88 ± 169.83 ACQ-6 score, mean ± SD (n = 193) 2.40 ± 1.18 AQLQ global score, mean ± SD (n = 192) 4.10 ± 1.31 Healthcare resource utilization related to asthma Hospitalization in the year prior to the screening visit Mean ± SD 0.20 ± 0.81 n (%) 19 (9.3) Emergency room visit in the year prior to the screening visit, n (%) 38 (18.5) Biomarkers FeNO, mean ± SD, ppb (n = 61) 42.2 ± 34.83 Baseline FeNO level, n (%) <25 ppb 22 (10.7) ≥25 ppb 39 (19.0) ≥50 ppb 20 (9.8) Missing 144 (70.2) ACQ-6, 6-item Asthma Control Questionnaire; AQLQ, Asthma Quality-of-life Questionnaire; BD, bronchodilator; BMI, body mass index; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; ppb, parts per billion; SD, standard deviation.ConclusionsIn this initial sample from the RAPID study, patients prior to initiating dupilumab had uncontrolled asthma and some had a history of smoking. Patients had a high number of exacerbations in the past year, impaired lung function, and poor asthma control and quality of life, suggesting a population with a high disease burden despite standard-of-care treatment.Please refer to page A212 for declarations of interest related to this abstract.