Table 1.

Studies of omalizumab in adults and adolescents with moderate-to-severe allergic asthma³⁵

Study	Patients		Study treatments	Study duration (weeks)	Annual exacerbation rate
	n	Characteristics			Between-group difference	Reduction (%)	P-value
Busse study15	525	Severe allergic asthma requiring daily ICS	Omal + ICS vs placebo + ICS	52	0.40	40.3%	<0.001
Solèr study16	546	Moderate-to-severe allergic asthma, symptomatic despite ICS	Omal + ICS vs placebo + ICS	52	0.70	57.6%	<0.001
Holgate study31	341	Severe allergic asthma	Omal + ICS vs placebo + ICS	32	0.42	26.5%	0.165
INNOVATE study34	419	Poorly controlled severe persistent allergic asthma	Omal + ICS vs placebo + ICS	28	0.49	26.6%	0.039
ETOPA study30	312	Poorly controlled, moderate-to-severe allergic asthma	Omal + CAT vs placebo + CAT	52	1.49	60.4%	<0.001
SOLAR study32	405	Moderate-to-severe asthma and persistent allergic rhinitis	Omal + ICS vs placebo + ICS	28	0.29	37.5%	0.027
ALTO safety studya	1899	Severe asthma	Omal + CAT vs placebo + CAT	24	0.18	15.3%	0.077
Pooled analysis35	4308	Severe (93% of patients) or moderate asthma	Omal vs control	Annualized	0.56	29.3%	<0.0001

^aUnpublished study (data on file at Novartis).

Abbreviations: Omal, omalizumab; ICS, inhaled corticosteroids; CAT, current asthma therapy.