Benralizumab lives up to its phase 3 results in real-world findings

The efficacy of benralizumab for severe eosinophilic asthma was confirmed in a retrospective cohort trial utilising US claims data. Exacerbation rates and the use of controller medication were significantly diminished with benralizumab treatment.

After demonstrating significant results in phase 3 trials, the anti-IL-5 antibody benralizumab has been approved by the EMA as add-on maintenance medication in adult patients with severe eosinophilic asthma insufficiently controlled by a combination of inhaled corticosteroids and long-acting beta-agonists [1,2]. This new analysis assessed whether the rates of 51% decreased exacerbations observed in phase 3 would be confirmed in real-world data [3]. The presented retrospective cohort study included patients from medical claims who started benralizumab between 2017 and 2019 [1]. The index date in this pre-post study was the first day after the drug was taken for the first time. Data from 12 months before this day was compared with that of 12 months after the index date. The participants of the primary and secondary cohort were all naïve to biologic treatment and had suffered from ≥2 exacerbations in the pre-index course. The 204 patients of the primary cohort all had ≥2 records of benralizumab, while the secondary or persistent group contained 103 subjects with ≥6 records. Moreover, 114 patients switching from omalizumab and 97 changing from mepolizumab to benralizumab were analysed.

Mean age in the primary cohort was 45.3, 68.6% were women, 77.5% had comorbidity of allergic rhinitis, 45.1% gastroesophageal reflux disease, and 45.6% hypertension. Asthma exacerbation rates were calculated per person-year (PY). The results revealed a 55% reduction (3.25 vs 1.47 per PY) for the benralizumab users within the primary and 62% (3.23 vs 1.23 per PY) in the persistent cohort. Both differences were significant with a P<0.001 for pre- and post-index comparisons. Of note, 41.2% and 42.7% under benralizumab in the primary and persistent cohort, respectively, did not experience any exacerbations during the post-index period. The outcomes for the switch cohorts were similar: 54% reduction when changing from omalizumab and a 34% drop in exacerbations with previous mepolizumab. The ameliorations were also consistent with a decrease in cumulative dosage of oral corticosteroids in the post-index period: in the primary cohort, 82% received steroid maintenance pre-index, but only 50% post-index (P<0.001) (see Figure). “Additionally, rescue medication use, commonly prescribed controllers, and antibiotics also decreased in the post-index period,” Dr Donna Carstens (AstraZeneca, Wilmington, DE, USA) pointed out with regard to significance for short-acting beta-agonists (P<0.001) and the combination of inhaled corticosteroids (ICS), with long-acting β2-adrenergic receptor agonists (P<0.001). In view of the study design that lacked a control arm, further research confirming the results is desirable. “Patients treated with benralizumab in this real-world analysis experienced a significant reduction in asthma exacerbations consistent with pivotal trials, as well as those who switched from other biologics,” concluded Dr Carstens.

Figure: Reduction of oral corticosteroid use among benralizumab receivers [1]



OCS, oral corticosteroids.

1. Carstens D, et al. Real-World Effectiveness of Benralizumab on Asthma Exacerbations: Results from the ZEPHYR 1 Study. Session TP015: Updates in Adherence and treatment of lung disease. ATS 2021 International Conference, 14-19 May.
2. https://www.ema.europa.eu/en/medicines/human/EPAR/fasenra
3. Bleecker ER, et al. Lancet. 2016 Oct 29;388(10056):2115-2127.

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Posted on 5 July 2021