Table 2.

Level of Omalizumab Efficacy on Asthma Severity Indicators

		Maximum Symptom Days*			Asthma Burden Index§			Any Exacerbations¶
Subgroup (Biomarker @ Baseline)	N	Effect	P	p-int	Effect	P	p-int	OR (95% CI)	P	p-int
log(IL-13/UBE) @ CR30, 72hr
≤ −1.5	18	−0.27	0.78	0.90	0.71	0.54	0.37	2.09 (0.43 - 10.2)	0.35	0.83
> −1.5	16	−0.10	0.91		−0.69	0.51		1.65(0.34-8.06)	0.52
CD3+CD4+CD25+CD127-FoxP3+ (Abs cells /μL)
≥ 25	31	−0.59	0.39	0.76	−0.48	0.54	0.98	0.55(0.18-1.73)	0.30	0.47
> 25	27	−0.30	0.66		−0.51	0.52		1.02(0.31-3.35)	0.98
CD3+CD4+CD25+FoxP3+ (Abs cells/μL)
≥ 28	27	−0.61	0.37	0.95	−0.85	0.27	0.65	0.69(0.22-2.17)	0.52	0.85
> 28	31	−0.55	0.42		−0.35	0.66		0.81(0.24-2.76)	0.74

^*The number of days with symptoms was calculated as the largest of the following variables during the previous 2 weeks: number of days with wheezing, chest tightness, or cough; number of nights of sleep disturbance; and number of days when activities were affected. This symptom scale ranges from 0 to 14 days per 2-week period.

^§The Composite Asthma Severity Index (CASI) quantifies disease severity by taking into account impairment, risk and the amount of medication needed to maintain control. CASI scores include 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations.

^¶An exacerbation was defined as a prednisone burst (a minimum of 20 mg per day of prednisone, or the equivalent, taken for any 3 of 5 consecutive days) or a hospitalization.