Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma

Abstract

Objective:

This pooled analysis assessed the safety of omalizumab in children with allergic (immunoglobulin E-mediated) asthma.

Study design:

Two double-blind, placebo-controlled studies in children (6 to < 12 years) with moderate-to-severe allergic asthma investigated the efficacy/safety of omalizumab. Children on optimized asthma care (inhaled corticosteroids ± other controller medications) were randomized (2:1) to omalizumab (75–375 mg sc, q2 or q4wk) or placebo. Pooled safety findings from these trials are presented in this publication.

Results:

The safety population included 926 children (omalizumab, n = 624; placebo, n = 302). Adverse events (AEs) were more frequently reported in the placebo (91.7%) than omalizumab (89.7%) group. The most common AEs were nasopharyngitis, upper respiratory tract infection and headache. Suspected treatment-related AEs included headache, erythema and urticaria; none of which were reported by ≥2% of patients receiving omalizumab. Serious AEs (SAEs) were reported by 3.4% and 6.6% of patients receiving omalizumab and placebo, respectively; the most common were appendicitis, pneumonia and bronchitis; no deaths were reported.

Conclusions:

Omalizumab has an acceptable safety profile, with a risk of AEs similar to placebo. This, combined with its efficacy profile, suggests that omalizumab may provide an additional asthma management option for children (6 to < 12 years) uncontrolled with current therapy that follows established guidelines.

Key words::

• Asthma
• IgE
• Omalizumab
• Pediatric
• Safety
• Tolerability

Transparency

Declaration of funding

The study was sponsored by Novartis Pharma AG.

Declaration of financial/other relationships.

A.F., C.F.V. and S.J. have disclosed that they are employees of the study sponsor.

Acknowledgments

The authors were assisted in the preparation of the manuscript by professional medical writers, Brian Jepson and Sonie Modino (ACUMED). Writing support was funded by the study sponsor.

Notes

*This pooled evaluation analyzed the safety of omalizumab in children aged 6 to <12 years with allergic asthma; therefore twelve-year-old children enrolled in this study were excluded.