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Published on: June 4, 2017
Systemic reaction rates with omalizumab, subcutaneous immunotherapy, and combination therapy in children with
Insights
For children with allergic asthma, omalizumab and combination therapy showed significantly lower systemic reaction rates than subcutaneous immunotherapy alone. Combination therapy with omalizumab and SCIT is safe and effective for managing allergic asthma in children.
Area of Science:
- Pediatric Allergy and Immunology
- Asthma Management
- Immunotherapy Safety
Background:
- Omalizumab is effective for moderate-to-severe persistent allergic asthma in children but lacks discontinuation guidelines and is costly.
- Subcutaneous immunotherapy (SCIT) offers lasting benefits post-treatment but is contraindicated in poorly controlled asthma.
- This study is the first U.S. comparison of safety profiles for omalizumab, SCIT, and combination therapy in pediatric allergic asthma.
Purpose of the Study:
- To compare the safety of omalizumab, SCIT, and combination therapy in children with allergic asthma.
- To determine and compare the rates of systemic reactions (SRs) across the three treatment groups.
- To test the hypothesis that combination therapy has SR rates comparable to omalizumab alone.
Main Methods:
- Retrospective study of children aged 6-18 with allergic asthma treated between July 2010 and June 2017.
- Analysis of treatment groups: SCIT (30 patients), omalizumab (30 patients), and combination therapy (29 patients).
- Primary endpoint: determination of systemic reaction (SR) rates per treatment group, based on records of injections and patient outcomes.
Main Results:
- Overall, 89 patients were analyzed: SCIT (1550 injections), omalizumab (729 injections), and combination (954 injections).
- SR rates were 1.2% for SCIT, 0.4% for omalizumab, and 0.3% for combination therapy.
- Omalizumab and combination therapy groups exhibited significantly lower SR rates compared to SCIT (p=0.045 and p=0.011, respectively), with no significant difference between omalizumab and combination therapy (p=0.73).
Conclusions:
- Omalizumab and combination therapy are associated with significantly lower systemic reaction rates in children with moderate-to-severe persistent allergic asthma compared to SCIT alone.
- Combination therapy (omalizumab plus SCIT) is safe in children receiving omalizumab.
- SCIT may serve as an effective omalizumab-sparing strategy and a bridge to safely initiate SCIT.
Abstract:
Background: For children with moderate-to-severe persistent allergic asthma, omalizumab is effective. However, it is expensive, and there are no current guidelines for discontinuation. Subcutaneous immunotherapy (SCIT) is the only approach that can provide persistent beneficial effects after treatment is discontinued. However, SCIT is contraindicated in poorly controlled asthma. Therefore, we performed, to our knowledge, the first U.S. study that exclusively compared the safety of omalizumab, SCIT, and combination (omalizumab and SCIT) therapy in children with allergic asthma. Objective: We hypothesize that the systemic reaction (SR) rates in children who receive combination therapy are comparable with omalizumab alone. Methods: We performed a retrospective study of children ages 6-18 years old with allergic asthma who, from July 2010 to June 2017, received SCIT, omalizumab, or combination therapy in our children's allergy clinic. Our primary end point was to determine the SR rate among each of these groups. Results: We reviewed the records of 89 patients: 30 patients with SCIT (1550 injections), 30 patients with omalizumab (729 injections), and 29 patients with combination therapy (954 injections). In the SCIT group, 19 SRs (1.2% of injections) occurred in 10 patients (33%). In the omalizumab group, three SRs (0.4% of injections) occurred in three patients (10%). Similarly, in the combination group, three SRs (0.3% of injections) occurred in three patients (10%). Compared with the SR rate in the SCIT group, both omalizumab and combination groups had significantly lower SR rates (p = 0.045 and p = 0.011, respectively). The SR rates in children who received omalizumab and children who received combination therapy were not statistically different (p = 0.73). Conclusion: Children with moderate-severe persistent allergic asthma who received omalizumab or combination therapy had significantly lower SR rates compared with children with allergic asthma who received SCIT alone. SCIT in children treated with omalizumab was safe and may serve both as an omalizumab-sparing treatment and as a bridge to safely administer SCIT.
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