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