TABLE 4

Benralizumab versus mepolizumab: matched and unmatched treatment comparisons of clinically significant asthma exacerbations and asthma exacerbations resulting in ED visit or hospitalisation, and change from baseline in pre-bronchodilator FEV1

Efficacy outcomeTreatment comparison
SIROCCO/CALIMA#MENSA/DREAMSIROCCO/CALIMA
Benralizumab Q8W versus placebo (no matching adjustment)#Mepolizumab versus placeboBenralizumab Q8W versus placebo (with matching adjustment)
Annualised rate of asthma exacerbations
 Clinically significant exacerbations0.54 (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 320.11 (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)ƒ0.09 (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.