Table 1.

Patient characteristics and primary endpoints of trials included

Source	Study design			Baseline characteristicsa				Efficacy
	Study design	Number of patients	Treatment duration (wk)	Age (yr)	FEV1 (%pred)	Serum IgE level (IU/mL)	Baseline ICS use (μg/d)	Primary end points
MacGlashan et al23  Omalizumab	OL	15	n/a	29.8	n/a	192	n/a	Free IgE levels: decrease to 1% of pretreatment levels. FcεRI densities: 97% reduction.
Humbert et al28  Omalizumab  Control	DB	419	28	43.4 43.3	61.0 61.6	197.6 189.6	2,359b 2,301b	Clinically significant asthma exacerbation rate: 0.68 vs 0.91 with placebo (RR =0.738, P=0.042).
Lanier et al35  Omalizumab  Control	DB	627	52	8.7 8.4	86.0 87.2	476.0 456.9	517.8c 509.5c	Clinically significant asthma exacerbations: 31% (24 wk), 43% (52 wk) reductions. ICS dose (adjustable steroid phase): 4% reduction vs 2% increase in placebo. Safety: no difference in overall incidence of AE.
Milgrom et al36  Omalizumab  Control	DB	334	28	9.4 9.5	84 85	348 323	284b 267b	Steroid-reduction phase:  1. % patient with complete BDP withdrawal: 55% vs 39% with placebo.  2. % patients had asthma exacerbation episodes: 18.2% vs 38.5% with placebo. Safety: no evidence of clinically significant drug toxicity or serious treatment-related AEs.

Notes:

^aData are shown as mean;

^bBDP equivalent;

^cfluticasone propionate equivalent.

Abbreviations: BDP, beclomethasone dipropionate; FEV₁, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; IgE, immunoglobulin E; OL, open-label; DB, double-blind; AEs, adverse events; wk, weeks; yr, year; n/a, not applicable; RR, risk ratio.