Table 3. Selected Pediatric Omalizumab Clinical Trials6,7

Study
Patients and Baseline Treatment
Omalizumab Study Treatment
Primary Endpoints
Results
Milgrom et al.6
RDBPC
  • n = 334
  • Age: 6-12 years
  • Well controlled with inhaled corticosteroids (doses equivalent to 168 to 420 mcg/day of BDP) and bronchodilators

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

  • OMZ n=225
  • Placebo n=109
  • Steroid-stable phase: BDP dose kept constant for 16 weeks
  • Steroid-reduction phase: BDP dose reduced over 8 weeks to minimum tolerated dose
    • Minimum dose maintained for 4 additional weeks
 BDP does reduction, symptoms, spirometry, AE
  • Median BDP dose reduction of 100% with OMZ vs. 66.7% with placebo (p=0.001)
  • BDP completely withdrawn in 55% receiving OMZ vs. 39% receiving placebo (p=0.004)
  • Steroid stable phase:
    • Asthma exacerbations occurred in 15.6% receiving OMZ vs. 22.9% receiving placebo (p=0.095)
  • Steroid reduction phase:
    • Asthma exacerbations occurred in 18.2% receiving OMZ vs. 38.5% receiving placebo (p<0.001)
  • No statistical difference in symptom scores or spirometry
  • No serious AE
Lemanske et al.7
RDBPC
  • Same as Milgrom et al.6
  • Same as Milgrom et al.6
 Mean change from baseline in asthma-related QOL scores
  • End of steroid-stable phase:
    • No statistical difference in PAQLQ scores between groups
  • End of steroid-reduction phase:
    • Greater mean change from baseline in activities scores (p<0.05) and symptoms scores (p<0.05) with OMZ vs. placebo
    • No statistical difference in emotions scores between groups
    • The overall mean score change from baseline was statistically significant with OMZ vs. placebo (p<0.05)
  • End of study:
    • Greater proportion of OMZ patients achieved a clinical improvement in asthma-related QOL
AE=Adverse event, BDP=beclomethasone dipropionate or equivalent inhaled steroid, DBPC=double-blind, placebo-controlled, n=number of patients in study group, OMZ=omalizumab, PAQLQ=Pediatric Asthma Quality of Life Questionnaire, QOL=Quality of Life, RDBPC=randomized, double-blind, placebo-controlled trial, SC=subcutaneous

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