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The following is a summary of “Treating eosinophilic exacerbations of asthma and COPD with benralizumab (ABRA): a double-blind, double-dummy, active placebo-controlled randomised trial,” published in the January 2025 issue of Pulmonology by Ramakrishnan et al.
Exacerbations of asthma and chronic obstructive pulmonary disease (COPD), often linked to critical illness, frequently involve eosinophilic inflammation, a treatable trait.
Researchers conducted a retrospective study to evaluate whether a single injection of benralizumab, alone or with prednisolone, improved clinical outcomes in patients with eosinophilic exacerbations compared to prednisolone alone.
They performed the Acute Exacerbations Treated with Benralizumab trial (ABRA), a multicenter, phase 2, double-blind, double-dummy, active placebo-controlled randomized trial across Oxford University Hospitals NHS Foundation Trust and Guy’s and St Thomas’ NHS Foundation Trust in the UK. Adults with blood eosinophil count≥300 cells/μL, experiencing acute asthma or COPD exacerbations, were randomly assigned (1:1:1 ratio) to receive either BENRA plus PRED (prednisolone 30 mg daily for 5 days + 100 mg benralizumab injection), BENRA (placebo tablets + 100 mg benralizumab), or PRED (prednisolone + placebo injection). Randomization was centralized via an interactive computer system. All patients and research staff were masked to treatment allocation and blood results. The co-primary outcomes were treatment failure proportion over 90 days and total visual analogue scale (VAS) symptoms at day 28, comparing pooled benralizumab groups with the prednisolone-alone group, analyzed in the intention-to-treat population.
The results showed that between May 13, 2021, and Feb 5, 2024, 287 patients were screened, with 129 excluded due to the lack of exacerbation or failure to meet eosinophil criteria. Of the 158 eligible patients with acute eosinophilic exacerbations (mean age 57 years, 54% female, 46% male), 53 were assigned to the PRED group, 53 to the BENRA group, and 52 to the BENRA plus PRED group. At 90 days, treatment failure occurred in 39 (74%) of 53 patients in the PRED group, compared with 47 (45%) of 105 patients in the pooled-BENRA group (OR 0·26 [95% CI 0·13–0·56]; p=0·0005). The 28-day VAS mean difference was 49 mm (95% CI 14–84; p=0·0065), favoring the pooled-BENRA group. There were no fatal adverse events, and benralizumab was well tolerated. Hyperglycemia and sinusitis occurred only in the PRED group.
Investigators concluded the benralizumab demonstrated superior efficacy compared to prednisolone alone in treating acute eosinophilic exacerbations of asthma and COPD, suggesting a potentially new treatment approach for these conditions.
Source: thelancet.com/journals/lanres/article/PIIS2213-2600(24)00299-6/fulltext