Efficacy outcome | Treatment comparison | ||
SIROCCO/CALIMA# | MENSA/DREAM | SIROCCO/CALIMA | |
Benralizumab Q8W versus placebo (no matching adjustment)# | Mepolizumab versus placebo | Benralizumab Q8W versus placebo (with matching adjustment) | |
Annualised rate of asthma exacerbations¶ | |||
Clinically significant exacerbations | 0.54 (0.47–0.61) | 0.51 (0.44–0.58) | 0.48 (0.43–0.55) |
Exacerbations resulting in ED visit or hospitalisation | 0.65 (0.46–0.93) | 0.48 (0.31–0.73) | 0.48 (0.33–0.68) |
Change in pre-bronchodilator FEV1 L+ | |||
From baseline to week 32 | 0.11 (0.05–0.18) | 0.07 (0.02–0.13) | 0.10 (0.04–0.17) |
From baseline to end of study§ | 0.11 (0.05–0.18) | 0.09 (0.04–0.14) | 0.11 (0.04–0.17) |
From baseline to end of study, excluding data from MENSA | 0.11 (0.05–0.18) | 0.06 (–0.04–0.16)ƒ | 0.09 (0.03–0.14)# |
ED: emergency department; FEV1: forced expiratory volume in 1 s; Q8W: every 8 weeks (first three doses every 4 weeks). #: includes only patients receiving fluticasone propionate ≥880 µg·day−1; ¶: data presented as rate ratio (95% CI); +: data presented as mean (95% CI); §: end of study was at the following time points: SIROCCO, 48 weeks; CALIMA, 56 weeks; MENSA, 32 weeks; DREAM, 52 weeks; ƒ: comparison excludes MENSA, includes DREAM mepolizumab 75 mg intravenous versus placebo; ##: comparison includes matching adjustment to DREAM only.