Systematic review on the use of omalizumab for the treatment of asthmatic children and adolescents

Abstract Background There are less data on omalizumab treatment in pediatric asthma than in adult population. Thus, to establish the efficacy and safety of subcutaneous omalizumab as an add‐on therapy, a systematic review of placebo‐controlled studies was performed. Methods Primary outcome was the frequency of asthma exacerbations. Secondary outcomes included spirometric measures, rescue medication use, asthma symptoms, health‐related quality of life, and adverse events. Results Three randomized controlled trials (1381 participants) fulfilled the selection criteria. During the stable phase, omalizumab decreased the number of patients with at least one significant asthma exacerbation (26.7% vs. 40.6%, NNTB = 7, 95% CI , 5, 11). The predefined post hoc subgroup analysis showed that duration of treatment did not influence this result. During the steroid reduction phase, omalizumab reduced the number of patients with at least one exacerbation ( RR = 0.48, 95% CI , 0.38, 0.61; NNTB = 6, 95% CI , 4, 8) and also the mean number of asthma exacerbations per patient ( MD = −0.44, 95% CI , −0.72, −0.17) when compared to placebo. The frequency of serious adverse events was similar between omalizumab (5.2%) and placebo (5.6%), and there were no evidence of increased risk of hypersensitivity reactions, nor malignant neoplasms. Conclusions Data indicate that the efficacy of an add‐on omalizumab in patients with moderate‐to‐severe allergic asthma uncontrolled with recommended inhaled steroid treatment is accompanied by an acceptable safety profile.