TABLE 1.
Summary of the effect of treatment on pre-bronchodilator forced expiratory volume in 1 s (FEV1), asthma exacerbations and mortality
Study [ref.] | Subjects n | Duration weeks | Asthma severity# | Treatment group | Change from baseline in pre-bronchodilator FEV1 mL | Exacerbations¶ | Mortality %+ | |
Overall | ED and hospitalisation | |||||||
Busseet al. [79] | 36 010 | 26 | Moderate | ICS | Not reported | 11.7% | 0.60% | 0 |
ICS/LABA | Not reported | 9.8% | 0.66% | 0 | ||||
DREAM [80] | 616 | 52 | Severe | Placebo | 60 | 2.40 | 0.43 | 0 |
Mepolizumab | 115–140 | 1.15–1.46 | 0.17–0.25 | 1 | ||||
MENSA [81] | 576 | 32 | Severe | Placebo | 86 | 1.74 | 0.20 | 1 |
Mepolizumab | 183–186 | 0.83–0.93 | 0.08–0.14 | 0 | ||||
MUSCA [82] | 551 | 24 | Severe | Placebo | 56 | 1.21 | 0.10 | 0 |
Mepolizumab | 176 | 0.51 | 0.03 | 0 | ||||
CALIMA [83] | 1306 | 56 | Severe | Placebo | 215§ | 0.93§ | 0.04§ | 0 |
Benralizumab | 330–340§ | 0.60–0.66§ | 0.04–0.05§ | 0 | ||||
SCIROCCO [84] | 1205 | 48 | Severe | Placebo | 239§ | 1.33§ | 0.18§ | 0 |
Benralizumab | 345–398§ | 0.65–0.73§ | 0.06–0.11§ | 0 | ||||
Castroet al. [85] | 953 | 52 | Severe | Placebo | 120 | 1.81 | 0.12 | 0 |
Reslizumab | 220 | 0.84 | 0.077 | 0 | ||||
QUEST [86] | 1902 | 52 | Moderate-to-severe | Placebo | 180–210ƒ | 0.87–0.97 | 0.065 | 0 |
Dupilumab | 320–340ƒ | 0.46–0.52 | 0.035 | 0 |
Ranges indicate results with different doses/routes of administration. ED: emergency department; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist. #: asthma severity based on treatment requirements and prior asthma exacerbation rates; ¶: events are expressed as episodes per patient per year, unless otherwise specified; +: rounded to 0 decimal places; §: data are for the subgroup with severe asthma and eosinophils ≥300 cells·µL−1 (n=728 in CALIMA and n=809 in SCIROCCO); ƒ: change from baseline at week 12 (all other FEV1 data presented as change from baseline at the final study visit).