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Table 11Characteristics of head-to-head studies comparing omalizumab with placebo in children and adults

StudyStudy design
N
Duration
Country
Population
Setting
DoseQuality rating
Niebauer et al. 200692Systematic review with meta-analysis
5 trials (2,056 patients)
Multinational

Adults and children with asthma; 3 with adult and adolescent patients with moderate to severe asthma, 1 trial of children and adolescents with allergic asthma, 1 with adults and adolescents with asthma and allergic rhinitis; concurrent ICS use in all trials
0.016 mg/kg per IU/mL of IgE every 2 or 4 weeksFair
Walker et al. 200693Systematic review with meta-analysis

14 DB RCTs (15 group comparisons; 3,143 patients)
Trials of any duration were included
Multinational

Adults and children with chronic asthma
OM (SQ, IV or inhaled)Good
Busse, et al. 200178

Finn et al. 200379

Lanier et al. 200580

+ Unpublished data from FDA89
RCT DB

525

28 weeks (16 weeks followed by 12 weeks tapering ICS dose)

Optional 24 week DB extension (N = 460)
US and UK

Age 12–75, moderate to severe allergic asthma requiring daily ICS, on stable BDP dose 4 wks prior to randomization and during wks 1–16

Multicenter (5)
0.016 mg/kg per IU/mL of IgE every 4 weeks (150 mg or 300 mg every 4 wks or 225 mg, 300 mg, or 375 mg every 2 wks)Fair
Holgate et al. 200481

+ Unpublished data from FDA89
RCT DB

246

32 weeks (16 week treatment phase, 16 week steroid reduction phase)
Multinational

Age 12–75, severe asthmatics, optimally controlled, requiring high dose FP (between 1000 and 2000 mcg/day) stabilized for 4 wks prior to randomization; allergic response (> 1 positive SPT) to aeroallergen(s)

Multicenter
0.016 mg/kg per IU/mL of IgE every 4 weeksGood
Humbert et al. 200582

INNOVATE
RCT DB

482

28 weeks
Multinational

Age 12–75, positive SPT to ≥ 1 perennial aeroallergen, severe persistent asthma requiring regular treatment with >1000 mcg BDP or equivalent LABA, continued high dose ICS + LABA throughout study

Multicenter (hospital clinics)
0.016 mg/kg per IU/mL of IgEFair
Lanier et al 200990RCT DB (2:1)

627

52 weeks (24 week fixed steroid phase, 28 week adjustable steroid phase)
Multinational

Age 6–12 with uncontrolled moderate to severe IgE-mediated asthma despite treatment with medium- or high-dose ICSs with or without other controller medications

Multicenter
75–375 mg SC every 2 or 4 weeksFair
Milgrom et al. 200183

Lemanske et al. 200284

+ Unpublished data from FDA89
RCT DB

334

28 weeks (16 week stable steroid phase, 12 week steroid reduction phase)
United States

Age 6–12, moderate to severe allergic asthma of at least 1 year duration that was well controlled with ICSs equivalent to 168–420 mcg/day BDP, positive SP

Multicenter
0.016 mg/kg per IU/mL of IgE every 2 or 4 weeksFair
Ohta et al. 200991RCT DB

315

28 weeks (16 week treatment phase, 12 week follow up phase)
Japan

Age 20–75, uncontrolled moderate to severe asthma despite high-dose ICSs (≥ 800 mcg/day BDP or equivalent) + ≥ 1 other standard therapy (LABA, LRTA, theophylline, etc), positive SPT or in vitro reactivity to ≥ 1 perennial aeroallergen, serum total IgE 30–700 IU/mL

Multicenter (73)
≥ 0.016 mg/kg per IU/mL of IgE every 2 or 4 weeksFair
Solèr et al. 200185

Buhl et al. 200286

Buhl et al. 200287

+ Unpublished data from FDA89
RCT DB

546

28 weeks (16 week stable ICS phase, 8 week reduction phase,4 week stable phase)

24 week DB extension (N = 483)
Multinational

Age 12–75, Moderate-severe allergic asthma

Multicenter
≥ 0.016 mg/kg per IU/mL of IgEGood
Vignola et al. 200488

SOLAR
RCT DB

405

28 weeks
Multinational

Age 12–74, stable on ≥400 mcg BUD, continued BUD treatment, allergic asthma and PAR

Concomitant asthma and rhinitis

Multicenter
≥ 0.016 mg/kg per IU/mL of IgE every 4 weeksFair

Abbreviations: AQLQ= Asthma Quality of Life Questionnaire; BDP = beclomethasone dipropionate; FP = fluticasone propionate; ICS= inhaled corticosteroid; LSM= least squares mean; NNT= number needed to treat; OM= omalizumab; OR= odds ratio; PAQLQ= Pediatric Asthma Quality of Life Questionnaire; PAR= persistent allergic rhinitis; QOL= quality of life; RCT= randomized controlled trial; RQLQ= Rhinitis Quality of Life Questionnaire; SDM= standard differences in mean; SPT= skin prick test; WMD= weighted mean difference.

Symbol use: Drug X > Drug Y = statistically significant difference in outcomes favoring Drug X; Drug X > Drug Y trend = point estimate favors Drug X, but the difference is not statistically significant or tests of statistical significance were NR; No difference = no statistically significant difference or tests of statistical significance were not reported and outcomes are similar.

From: Results

Cover of Drug Class Review: Controller Medications for Asthma
Drug Class Review: Controller Medications for Asthma: Final Update 1 Report [Internet].
Jonas DE, Wines RCM, DelMonte M, et al.
Portland (OR): Oregon Health & Science University; 2011 Apr.
Copyright © 2011 by Oregon Health & Science University.

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