Table 4. Selected Adult Omalizumab Clinical Trials

Study
Patients and
Baseline Treatment
Omalizumab Study Treatment
Primary Endpoints
Results

Busse et al.8
DBPC parallel trial
  • n=525 patients
  • Age: 12-75 years
  • Inhaled corticosteroids (doses equivalent to 168 to 420 mcg/day of BDP)

Inhaled BDP and OMZ SC 0.016 mg/kg/igE (IU/mL) for 28 weeks or placebo

  • OMZ n=268
  • Placebo n=257
  • Steroid-stable phase: dose kept constant for 16 weeks
  • Steroid-reduction phase: dose reduced over 12 weeks to minimum tolerated dose
Number of exacerbations during steroid stable and reduction phases, steroid dose reduction
  • Steroid-stable phase:
    • > 1 exacerbations in 14.6% OMZ patients vs. 23.3% placebo patients (p=0.009)
  • Steroid-reduction phase:
    • Fewer OMZ patients with exacerbations vs. placebo (21.3% vs. 32.3%, respectively; p=0.004)
  • More OMZ patients achieved a > 50% reduction in steroid dose
    (72.4% vs. 54.9%, respectively; p<0.001)
Milgrom et al.9
RDBPC
  • n=317 patients
  • Age: 11-50 years
  • Inhaled corticosteroids (triamcinolone 200 mcg BID or equivalent)

    OR
  • Oral prednisone 20 mg daily or 40 mg every other day and inhaled corticosteroids

High dose
(5.8 mcg/kg/IgE [ng/mL]) or low dose (2.5 mcg/kg/IgE [ng/mL]) IV
OMZ for 20 weeks or placebo

  • OMZ:
    • High-dose n=106
    • Low-dose n=106
  • Placebo n=105
  • Steroid-stable phase: dose kept constant for 12 weeks
  • Steroid-reduction phase: dose reduced over 8 weeks to minimum tolerated dose

Improvements in asthma symptoms scores at 12 weeks

  • Range: 1 (none) to 7 (very great deal)
  • Baseline mean: 4

High dose OMZ:

  • Mean symptom score 2.8+ 0.1 (p=0.008 vs. placebo)
  • Reduction in oral steroid dose > 50% in 78% of patients (p=0.04 vs. placebo)
  • Reduction in inhaled steroid dose > 50% in 51% of patients (p=0.07 vs. placebo)

Low dose OMZ:

  • Mean symptom score 2.8+ 0.1 (p=0.005 vs. placebo)
  • Reduction in oral steroid dose > 50% in 57% of patients (p=0.23 vs. placebo)
  • Reduction in inhaled steroid dose > 50% in 49% of patients (p=0.12 vs. placebo)

Placebo:

  • Mean symptom score 3.1+ 0.1
  • Reduction in oral steroid dose > 50% in 33% of patients
  • Reduction in inhaled steroid dose > 50% in 38% of patients

 
BDP=beclomethasone dipropionate or equivalent inhaled steroid, DBPC=double-blind, placebo-controlled, n=number of patients in study group, OMZ=omalizumab, RDBPC=randomized, double-blind, placebo-controlled trial, SC=subcutaneous

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