A Real‐World Controlled Multicentre Study Evaluating the Association Between Benralizumab Therapy and Major Outcomes in Severe Asthma

BACKGROUND: Real-world data on benralizumab in patients with severe eosinophilic asthma-while controlling for confounding factors-is currently lacking. AIM: This real-world controlled multicentre study evaluated asthma outcomes in patients who received benralizumab compared with a severe asthma cohort who did not receive biologic therapy. METHODS: Two years of data from patients with severe eosinophilic asthma in the Australian Benralizumab Registry (ABenRa) and the Australasian Severe Asthma Registry (ASAR) were included in the analysis. Asthma control questionnaire-5 (ACQ-5) scores, asthma-related quality of life (AQLQ) scores, maintenance oral corticosteroid (OCS) dose, annualised exacerbation rate and clinical remission (ACQ-5 ≤ 1, with no asthma attacks or OCS use for 12 months, assessed at the 24-month follow-up) rates were compared between the groups after adjusting for baseline imbalances. RESULTS: A total of 211 participants from ABenRa (64.5% female; mean age 57.4 ± 14.5 years) and 250 from ASAR (63.1% female; mean age 53.7 ± 14.8 years) were included. ACQ and AQLQ improved significantly in both groups. Participants in the ABenRa showed greater improvements in ACQ at 12- (β = -0.5, p = 0.002) and 24-months (β = -0.5, p = 0.003), as well as in AQLQ at 12- (β = 0.6, p < 0.001) and 24-months (β = 0.4, p = 0.019), compared with the ASAR group, with no difference in maintenance OCS dose or annualised exacerbation rates between groups. At 12- and 24-months, approximately 60% of participants in the ABenRa achieved controlled or partially controlled asthma as per the GINA guidelines. Notably, clinical benefit was evident within 14 days of initiating treatment. A higher proportion of participants in the ABenRa achieved clinical remission (30.9% vs. 20.4%; OR 2.1 (95% CI 1.1, 4.1), p = 0.037). CONCLUSION: Benralizumab was associated with significant improvement in asthma outcomes in patients with severe eosinophilic asthma. This benefit persisted when compared with patients who had severe eosinophilic asthma but did not receive any biologic therapy.