TABLE III.

Level of omalizumab efficacy and baseline participant characteristics

Subgroup	No.	Symptom days per 2 weeks			ICS taken			Exacerbations/month
		Effect	P*	P for interaction†	Effect	P*	P for interaction†	OR (95% CI)	P*	P for interaction†
All participants
ITT with wash-in period	419	−0.48	<0.01	N/A	−108.6	<0.01	N/A	1.82 (1.33–2.50)	<0.01	N/A
ITT without wash-in period	419	−0.52	<0.01	N/A	−108.6	<0.01	N/A	1.85 (1.38–2.47)	<0.01	N/A
Dosing group
2-Wk dosing group	166	−0.39	0.09	0.62	−204.8	<0.01	0.02	2.54 (1.56–4.15)	<0.01	0.08
4-Wk dosing group	253	−0.54	<0.01		−50.2	0.22		1.42 (0.94–2.15)	0.09
FDA dosing chart
Standard	227	−0.46	0.02	0.71	−71.32	0.10	0.35	2.43 (1.53–3.84)	<0.01	0.21
Dose changed	87	−0.70	0.03		−118.5	0.09		1.27 (0.65–2.46)	0.48
Addition to chart	105	−0.35	0.24	0.71	−184.7	<0.01	0.35	1.50 (0.82–2.75)	0.19
Age
Age 11 y or younger	250	−0.56	<0.01	0.50	−128.0	<0.01	0.44	1.52 (1.04–2.21)	0.03	0.09
Age 12 y or older	169	−0.36	0.13		−75.9	0.14		2.76 (1.54–4.96)	<0.01
Treatment at randomization‡
Steps 1–2	113	−0.30	0.28	0.68	−128.6	0.03	0.58	2.16 (1.03–4.50)	0.04	0.44
Steps 3–4	152	−0.48	0.05		−54.0	0.28		1.44 (0.87–2.39)	0.16
Steps 5–6	154	−0.64	0.01		−105.5	0.04		2.21 (1.36–3.59)	<0.01
Exhaled nitric oxide
<20 ppb	158	−0.38	0.08	0.55	−40.5	0.45	0.11	1.15 (0.66–1.98)	0.63	0.05
≥20 ppb	155	−0.45	0.05		−164.2	0.03		2.57 (1.46–4.54)	<0.01
Blood eosinophils
<2%	69	−0.55	0.13	0.81	−94.1	0.25	0.76	0.56 (0.24–1.30)	0.18	<0.01
≥2%	337	−0.46	<0.01		−120.5	<0.01		2.13 (1.50–3.02)	<0.01
BMI
<25	302	−0.55	<0.01	0.44	−126.7	<0.01	0.36	1.46 (1.00–2.12)	0.05	0.03
≥25	117	−0.30	0.27		−61.0	0.32		3.17 (1.73–5.80)	<0.01
Dust mite sIgE
Negative	213	−0.14	0.50	0.01	−48.4	0.29	0.03	2.15 (1.34–3.44)	<0.01	0.43
Positive (>0.35 KUA/mL)	195	−0.87	<0.01		−191.7	<0.01		1.66 (1.06–2.60)	0.03
Total IgE
<700 IU/mL	384	−0.51	<0.01	0.52	−75.5	0.02	<0.01	1.66 (1.19–2.31)	0.23	0.75
≥700 IU/mL	35	−0.14	0.79		−504.6	<0.01		4.16 (1.41–12.3)	<0.01
Prestudy unscheduled visit?
No	91	−0.20	0.53	0.30	46.4	0.50	0.01	1.11 (0.54–2.29)	0.77	0.13
Yes	328	−0.57	<0.01		−153.0	<0.01		2.06 (1.45–2.93)	<0.01

OR, Odds ratio.

Effects are differences between intervention and control participants during the double blind (not including the 3-month wash-in period) for symptom days/2 weeks and ICS taken (budesonide μg/day equivalents) and ORs for exacerbations. The omalizumab group serves as the OR reference population, so a value greater than 1 indicates a greater reduction in exacerbations in the treatment group.

^*Indicates with-in subgroup effect.

^†Indicates between-group interactions and were adjusted for baseline levels.

^‡ICATA medication treatment steps are as follows: step 1, budesonide DPI 180 μg daily; step 2, budesonide DPI 80 μg twice daily; step 3, budesonide DPI 360 μg twice daily; step 4, Advair 250 μg/50 μg twice daily; step 5, Advair 250 μg/50 μg twice daily plus montelukast daily; step 6, Advair 500 μg/50 μg twice daily plus montelukast daily.