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Omalizumab outcomes for up to 6 years in pediatric patients with severe persistent allergic asthma
Antonio Nieto García1, Teresa Garriga-Baraut2, Ana María Plaza Martín3
1Pediatric Pulmonology and Allergy Unit, Hospital Universitari i Politècnic La Fe, Health Research Institute La Fe, Valencia, Spain.
Insights
Omalizumab significantly reduced exacerbations in children with severe allergic asthma for up to six years. This real-world study confirms its long-term effectiveness and safety in managing pediatric persistent allergic asthma.
Area of Science:
- Pediatric Allergy and Pulmonology
- Clinical Practice Research
- Immunotherapy Outcomes
Background:
- Limited data exists on long-term omalizumab outcomes in real-world pediatric settings.
- Previous studies often had restricted follow-up periods or patient numbers.
- This study addresses the need for comprehensive, long-term data in severe persistent allergic asthma.
Purpose of the Study:
- To evaluate the long-term effectiveness and safety of omalizumab in pediatric patients with severe persistent allergic asthma.
- To analyze the evolution of exacerbations and other clinical parameters over an extended treatment period.
- To establish omalizumab as a viable long-term therapeutic option in a large, real-world cohort.
Main Methods:
- A multicenter, observational, retrospective cohort study (ANCHORS) in Spain.
- Included pediatric patients (<18 years) initiating omalizumab between 2006 and 2018.
- Primary outcome: change in annual moderate-to-severe exacerbations compared to baseline.
Main Results:
- 484 pediatric patients were included; 101 (20.9%) completed 6 years of treatment.
- Annual exacerbations decreased significantly from 7.9 to 1.1 in the first year (P<.001) and remained low long-term.
- Other clinical parameters improved significantly and were maintained or improved further; adverse events were consistently low.
Conclusions:
- Omalizumab demonstrated a significant and sustained reduction in moderate-to-severe exacerbations in pediatric severe persistent allergic asthma.
- The treatment showed a favorable long-term safety profile.
- Results support omalizumab as an effective and well-tolerated long-term therapy for this patient population.
Background:
Various studies have assessed omalizumab outcomes in the clinical practice setting but follow-up and/or number of patients included were limited. We aim to describe the long-term outcomes of pediatric patients with severe persistent allergic asthma receiving omalizumab in the largest real-life cohort reported to date.
Methods:
ANCHORS was a multicenter, observational, retrospective cohort study conducted in 25 Pediatric Allergy and Pulmonology units in Spain. We collected data of patients < 18 years and initiating omalizumab between 2006 and 2018, from the year prior to omalizumab initiation to discontinuation or last available follow-up. The primary outcome was the evolution of the annual number of moderate-to-severe exacerbations compared with the baseline period.
Results:
Of the 484 patients included, 101 (20.9%) reached 6 years of treatment. The mean ± standard deviation number of exacerbations decreased during the first year of treatment (7.9 ± 6.6 to 1.1 ± 2.0, P < .001) and remained likewise for up to 6 years. The other clinical parameters assessed also improved significantly during the first year and stabilized or continued to improve thereafter. The percentage of patients experiencing adverse events was consistently low, and the main reason for discontinuation was good disease evolution.
Conclusion:
In this large, long-term, observational study, moderate-to-severe exacerbations decreased significantly from the first year of treatment with omalizumab. The beneficial effect was maintained in the long term, along with a good safety profile. Our results position omalizumab as an effective long-term treatment in pediatric patients with severe persistent allergic asthma.
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