A Phase II investigator-led trial investigating AstraZeneca’s Fasenra (benralizumab) treating eosinophilic exacerbations of asthma and chronic obstructive pulmonary disease (COPD) has demonstrated a statistically significant improvement compared with the use of standard of care.
Published in the Lancet yesterday (27 November), the ABRA study (NCT04098718) found that, after 90 days of treatment, 45% of patients who received Fasenra alone, or Fasenra in combination with prednisolone steroids suffered exacerbations compared with 74% of patients prescribed a five-day course of oral prednisolone steroids.
Go deeper with GlobalData
The results report that there were no fatal adverse events (AEs) and state that Fasenra was well tolerated. It notes that hyperglycaemia and sinusitis or sinus infection AEs were only observed in the steroid group.
The study was run as a double-blind, double-dummy, active placebo-controlled, randomised trial and ran between 13 May 2021 and 5 February 2024. It included 158 patients, randomly assigned treatment at the point of acute eosinophilic exacerbation of asthma or COPD.
The study originally screened 287 patients for inclusion, but 129 were excluded due to failure to capture an exacerbation of asthma or COPD, or to meet the eosinophil exclusion criteria.
Of the 158 patients, 54% were female and 46% were male, aged between 18 and 84 and with a mean age of 57. There were 53 patients in the steroid group, 53 in the Fasenra group, and 52 in the Fasenra plus steroid group.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataThe findings concluded: “Fasenra can be used as a treatment of acute eosinophilic exacerbations and achieves better outcomes than the current standard of care with prednisolone alone. These results offer a new way of treating eosinophilic endotypes of asthma and COPD exacerbations.”
Fasenra is a monoclonal antibody which works by targeting eosinophils (a type of white blood cell), to reduce lung inflammation. Fasenra is approved for the treatment of severe eosinophilic asthma (SEA), administered with injections every four weeks.
The study was funded by AstraZeneca. Fasenra was first approved by the US Food and Drug Administration (FDA) as an add-on maintenance treatment in November 2017. The therapy was approved for use in severe eosinophilic asthma in the UK in 2019.
Fasenra has also seen recent success in eosinophilic granulomatosis with polyangiitis (EGPA), for which it is currently approved in more than 80 countries. It was approved by the European Union (EU) last month.
The World Health Organization (WHO) reports that asthma affected an estimated 262 million people in 2019 and caused 455,000 deaths, with around half of all emergency flare-ups attributed to eosinophilic asthma. Meanwhile, COPD is the fourth leading cause of death worldwide and reportedly caused 3.5 million deaths in 2021, which accounts for approximately 5% of all global deaths that year.
