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Table 2 Main clinical outcomes from RCTs of omalizumab, mepolizumab and reslizumab in patients with severe asthma

From: The use of intravenous versus subcutaneous monoclonal antibodies in the treatment of severe asthma: a review

First author, year (study name) Patients Study treatment Main clinical outcomes
Omalizumab
 Busse, 2001 [25] Severe allergic asthma requiring daily ICS (n = 525) SC omalizumab q2w or q4w vs PBO for 28 wks Significantly fewer asthma exacerbations per patient vs PBO with stable ICSs (0.28 vs 0.54; p = 0.006) and during ICS reduction (0.39 vs 0.66; p = 0.004)
 Solèr, 2001 [26] Symptomatic allergic asthma on daily ICS (n = 546) SC omalizumab q2w or q4w vs PBO for 28 wks Significantly fewer asthma exacerbations per patient vs PBO with stable ICSs (0.28 vs 0.66; p < 0.001) and during ICS reduction (0.36 vs 0.75; p < 0.001)
 Holgate, 2014 [30] Severe allergic asthma on ICS (n = 246) SC omalizumab q2w or q4w vs PBO for 32 wks Significantly greater median reductions in ICS dose vs PBO (60% vs 50%; p = 0.003); ≥50% ICS dose reduction achieved by 73.8% vs 50.8% of patients (p = 0.001)
Mepolizumab
 Pavord, 2014 (DREAM) [67] Severe eosinophilic asthma (n = 621) IV mepolizumab 75, 250 or 750 mg q4w vs PBO for 13 doses Fewer clinically significant exacerbations per patient-year vs PBO (1.15–1.46 vs 2.40; p < 0.001)
Ortega, 2014 (MENSA) [32] Severe eosinophilic asthma on high-dose ICS (n = 576) IV mepolizumab 75 mg q4w or SC mepolizumab 100 mg q4w vs PBO for 32 wks Significantly decreased rate of exacerbations with IV (by 47%) and SC (by 53%) mepolizumab vs PBO (p < 0.001); significantly greater mean increases in FEV1 with IV (by 100 mL) and SC (by 98 mL) vs PBO (p < 0.05); significantly decreased rate of exacerbations needing hospitalisation with SC mepolizumab vs PBO (by 61%; p = 0.02)
 Bel, 2014 (SIRIUS) [31] Severe eosinophilic asthma on systemic corticosteroids (n = 135) SC mepolizumab 100 mg q4w vs PBO for 20 wks Significantly greater likelihood of reducing systemic corticosteroid dose vs PBO (OR 2.39; 95% CI 1.25–4.56; p = 0.008); significantly greater median dose reduction vs PBO (50% vs 0%; p = 0.007); significantly lower rate of exacerbations per year vs PBO (1.44 vs 2.12; p = 0.04)
 Chupp, 2017 (MUSCA) [33] Severe eosinophilic asthma on high-dose ICS (n = 274) SC mepolizumab 100 mg q4w vs PBO for 24 weeks Significantly improved SGRQ total score vs PBO (LSM change from baseline–15.6 vs − 7.9; p < 0.0001)
Reslizumab
 Castro, 2015 [37] Inadequately controlled asthma with ≥400/μL blood eosinophils (n = 953 in two duplicate studies) IV reslizumab 3.0 mg/kg q4w vs PBO for 52 wks Significantly reduced rate of exacerbations vs PBO (study 1 RR 0.50; 95% CI 0.37–0.67; study 2 RR 0.41; 95% CI 0.28–0.59; both p < 0.001); significantly greater increases in FEV1 vs PBO (study 1 RR 0.126; 95% CI 0.06–0.188; p < 0.0001; study 2 RR 0.090; 95% CI 0.003–0.153; p = 0.0057); significantly improved scores on the ACQ and AQLQ vs PBO (study 1 both p < 0.001; study 2 p < 0.001 and p < 0.01, respectively)
 Bjermer, 2016 [38] Inadequately controlled asthma with ≥400/μL blood eosinophils (n = 315) IV reslizumab 0.3 or 3.0 mg/kg q4w vs PBO for 16 wks Significant greater increases in FEV1 with 0.3 mg/kg (by 115 mL) and 3.0 mg/kg (by 160 mL) vs PBO (both p < 0.05); significantly improved scores on the ACQ and AQLQ vs PBO (p < 0.05)
  1. ACQ Asthma Control Questionnaire, AQLQ Asthma Quality of Life Questionnaire, CI confidence interval, FEV1 forced expiratory volume over 1 s, ICS inhaled corticosteroids, IV intravenous, LSM least squares mean, OR odds ratio, PBO placebo, q2w every 2 weeks, q4w every 4 weeks, RCT randomised controlled trial, RR rate ratio, SC subcutaneous, SGRQ St George’s Respiratory Questionnaire