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DOI: 10.1055/s-0039-3403112
Baseline Predictors of Being Exacerbation-Free During 2 Years of Benralizumab Treatment
Publication History
Publication Date:
28 February 2020 (online)
Introduction: Integrated analyses of Phase III trials are important in characterizing patients who have the greatest long-term benefits with benralizumab.We aimed to examine the relationship between exacerbation frequency during 2 years of benralizumab treatment, baseline characteristics, and efficacy.
Methods: We performed post-hoc subgroup integrated analysis of the 48-week SIROCCO (Lancet 2016;388 : 2115 – 27) and 56-week CALIMA (Lancet 2016;388 : 2128 – 41) studies with the 56-week BORA extension study (Lancet Respir Med 2019;7 : 46 – 59). Patients receiving benralizumab 30 mg subcutaneously every 8 weeks who had baseline blood eosinophil counts ≥ 300 cells/µL were assessed. Patients were evaluated based on number of exacerbations experienced during the 2-year treatment period (0, 1, ≥ 2).
Results: Baseline pre-bronchodilator forced expiratory volume in 1 second (FEV1;%), pre-bronchodilator FEV1/forced vital capacity (FVC), and prior requirement for mechanical ventilation were significantly different for patients with 0 vs.1 exacerbations, with additional significant differences for patients with 0 vs. ≥ 2 exacerbations ([Table 1]). Greater improvements in Asthma Control Questionnaire-6 (ACQ-6) and Standardized Asthma Quality of Life Questionnaire for patients 12 years and older (AQLQ(S)+12) scores were observed for patients with 0 vs. 1/≥ 2 exacerbations, while lesser improvement in FEV1 and ACQ-6 and AQLQ(S)+12 scores was observed for the ≥ 2 exacerbation group vs. the other groups by 16 weeks and was sustained for 2 years.
Exacerbations in 2-year period |
P-values |
||||
---|---|---|---|---|---|
0 (n = 161) |
1 (n = 80) |
≥ 2 (n = 77) |
0 vs. 1 |
0 vs. ≥ 2 |
|
ACQ-6, Asthma Control Questionnaire 6; BD, bronchodilator; ED, emergency department; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICU, intensive care unit; PN, predicted normal; Q8W, every 8 weeks (first three doses every 4 weeks); SD, standard deviation. a Pts also received high-dosage inhaled corticosteroids/long-acting β2-agonists. b Means (SD). c n (%). d Missing data. |
|||||
Pre-BD FEV1 PN [%]b |
60 (15) |
56 (14) |
53 (14) |
0.030 |
< 0.001 |
Body mass index [kg/m²]b |
27 (5) |
27 (5) |
30 (8) |
0.508 |
0.001 |
ACQ-6 scoreb |
2.6 (0.9) |
2.7 (0.7) |
3.0 (1.0) |
0.328 |
0.001 |
Age at asthma diagnosis [years]b |
32 (17) |
29 (20) |
25 (17) |
0.235 |
0.002 |
≥ 1 exacerbations in the past 12 months leading to ED visitc |
16 (10) |
10 (13) |
18 (23) |
0.240 |
0.002 |
Post-BD FEV1 PN [%]b,d |
73 (18) |
70 (19) |
66 (19) |
0.290 |
0.006 |
Time since asthma diagnosis [years]b |
17 (13) |
20 (14) |
22 (14) |
0.071 |
0.006 |
Previous admission to ICU for asthmac |
8 (5) |
8 (10) |
13 (17) |
0.171 |
0.006 |
Pre-BD FEV1 (L)b |
1.84 (0.65) |
1.68 (0.55) |
1.61 (0.60) |
0.057 |
0.009 |
Time since first asthma symptoms started [years]b |
20 (14) |
22 (15) |
25 (14) |
0.132 |
0.010 |
Post-BD FEV1/FVC [%]b,d |
66 (13) |
63 (14) |
62 (12) |
0.081 |
0.013 |
Number of exacerbations in the previous 12 monthsc |
|||||
|
111 (69) |
49 (61) |
40 (52) |
0.249 |
0.014 |
|
50 (31) |
31 (39) |
37 (48) |
||
Pre-BD FEV1/FVC [%]b |
63 (12) |
59 (13) |
58 (12) |
0.020 |
0.015 |
Gastroesophageal refluxc |
27 (17) |
10 (13) |
24 (31) |
0.451 |
0.017 |
Post-BD FEV1 (L)b,d |
2.23 (0.81) |
2.10 (0.77) |
1.98 (0.79) |
0.212 |
0.027 |
Previously requiring mechanical ventilationc |
2 (1) |
5 (6) |
5 (6) |
0.042 |
0.038 |
Reversibility [%]b,d |
22 (19) |
27 (29) |
25 (20) |
0.153 |
0.321 |
≥ 1 exacerbations in the past 12 months leading to hospitalizationc |
29 (18) |
13 (16) |
22 (29) |
0.581 |
0.135 |
Conclusions: Patients who remained exacerbation-free during 2 years of benralizumab treatment were older at asthma onset, had better lung function, smaller intensive care unit asthma admission rate and body mass index, and less gastroesophageal reflux.