Fasenra Demonstrates Efficacy in Eosinophilic Asthma and COPD Exacerbations in Phase II Trial
核心洞察
A Phase II trial (ABRA study) showed that Fasenra, with or without prednisolone, significantly reduced exacerbations in eosinophilic asthma (搜索) and COPD (搜索) patients compared to prednisolone alone.
After 90 days, 45% of patients on Fasenra (with or without prednisolone) experienced exacerbations, versus 74% on prednisolone, indicating a substantial improvement with Fasenra.
The study reported that Fasenra was well-tolerated, with no fatal adverse events; hyperglycaemia and sinusitis were only observed in the prednisolone group.
AstraZeneca's Fasenra (benralizumab) has shown promising results in treating eosinophilic exacerbations of asthma (搜索) and chronic obstructive pulmonary disease (COPD (搜索)). A Phase II investigator-led trial, known as the ABRA study, demonstrated a statistically significant improvement with Fasenra compared to the standard of care, prednisolone.
ABRA Study: Key Findings
The ABRA study (NCT04098718), published in The Lancet, revealed that after 90 days of treatment, 45% of patients receiving Fasenra alone or in combination with prednisolone experienced exacerbations. In contrast, 74% of patients treated with a five-day course of oral prednisolone steroids suffered exacerbations. This double-blind, double-dummy, active placebo-controlled, randomised trial was conducted between May 13, 2021, and February 5, 2024.
The trial included 158 patients who were randomly assigned treatment at the point of acute eosinophilic exacerbation of asthma (搜索) or COPD (搜索). Originally, 287 patients were screened, but 129 were excluded due to failure to capture an exacerbation of asthma or COPD, or not meeting eosinophil exclusion criteria. The study population consisted of 54% females and 46% males, aged 18 to 84, with a mean age of 57. The treatment groups included 53 patients in the steroid group, 53 in the Fasenra group, and 52 in the Fasenra plus steroid group.
Safety and Tolerability
The study reported no fatal adverse events, and Fasenra was well-tolerated among patients. Notably, hyperglycaemia and sinusitis or sinus infection adverse events were exclusively observed in the steroid group, suggesting a potentially improved safety profile for Fasenra.
Clinical Implications
The study's findings suggest that Fasenra can be used as a treatment for acute eosinophilic exacerbations, leading to better outcomes than prednisolone alone. According to the researchers, these results present a new approach for treating eosinophilic endotypes of asthma (搜索) and COPD (搜索) exacerbations.
About Fasenra
Fasenra is a monoclonal antibody that targets eosinophils (搜索), a type of white blood cell, to reduce lung inflammation. It is approved for the treatment of severe eosinophilic asthma (搜索) (SEA) and is administered via injections every four weeks. The drug was first approved by the US Food and Drug Administration (FDA) in November 2017 as an add-on maintenance treatment and later approved for use in severe eosinophilic asthma in the UK in 2019.
Fasenra has also demonstrated success in treating eosinophilic granulomatosis with polyangiitis (搜索) (EGPA), with approvals in over 80 countries and recent approval by the European Union (EU).
Disease Burden
The World Health Organization (WHO) estimates that asthma (搜索) affected 262 million people in 2019, causing 455,000 deaths, with approximately half of emergency flare-ups attributed to eosinophilic asthma. COPD (搜索) is the fourth leading cause of death worldwide, causing 3.5 million deaths in 2021, representing about 5% of all global deaths.