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 q4 wk) 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.
RCT Entities:
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 q4 wk) 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.
Authors: Rohan Bir Singh; Lingjia Liu; Ann Yung; Sonia Anchouche; Sharad K Mittal; Tomas Blanco; Thomas H Dohlman; Jia Yin; Reza Dana Journal: Ocul Surf Date: 2021-05-15 Impact factor: 6.268
Authors: James S Leung; David W Johnson; Arissa J Sperou; Jennifer Crotts; Erik Saude; Lisa Hartling; Antonia Stang Journal: PLoS One Date: 2017-08-09 Impact factor: 3.240
Authors: Amelia Licari; Riccardo Castagnoli; Chiara Denicolò; Linda Rossini; Manuela Seminara; Lucia Sacchi; Giorgia Testa; Mara De Amici; Gian Luigi Marseglia Journal: Curr Respir Med Rev Date: 2017-03