Benralizumab Improves Histologic Response in Eosinophilic Esophagitis

A recent study published in the June 27 issue of the New England Journal of Medicine has revealed significant findings regarding the treatment of eosinophilic esophagitis (EoE). Conducted by Dr. Marc E. Rothenberg and his team at the Leiden University Medical Center in the Netherlands, the phase 3 randomized trial explored the efficacy of benralizumab in comparison to a placebo.

The trial involved 211 patients aged between 12 and 65, all of whom exhibited symptomatic and histologically active EoE. Participants were randomly divided into two groups: one receiving 30 mg of benralizumab and the other receiving a placebo, administered every four weeks. The study aimed to evaluate the histologic response and symptom relief of dysphagia, a common difficulty in swallowing associated with EoE, over a period of 24 weeks.

The results indicated that benralizumab produced a notably higher histologic response compared to the placebo. Specifically, 87.4 percent of patients treated with benralizumab showed a histologic response, as opposed to just 6.5 percent in the placebo group. This suggests that benralizumab is effective in reducing eosinophilic inflammation, a hallmark of EoE.

However, despite the promising histologic results, the study found no significant difference between the benralizumab and placebo groups regarding the improvement in dysphagia symptoms. The Dysphagia Symptom Questionnaire scores did not show substantial changes from baseline between the two groups. This points to a disconnect between histologic improvement and symptomatic relief for patients undergoing treatment with benralizumab.

Additionally, the study evaluated the Eosinophilic Esophagitis Endoscopic Reference Score, a metric used to assess the endoscopic appearance of the esophagus in EoE patients. Similar to the findings on dysphagia, there was no significant difference in the endoscopic scores between those treated with benralizumab and those given a placebo.

The safety profile of benralizumab was also examined, with 64.1 percent of patients in the benralizumab group and 61.7 percent in the placebo group reporting adverse events. The adverse events reported did not show a significant disparity between the two groups, suggesting that benralizumab is relatively safe but does not provide symptomatic relief for dysphagia.

The authors of the study concluded that while benralizumab achieves a higher histologic response, it does not translate into a greater reduction in dysphagia symptoms. This finding raises questions about the clinical relevance of monitoring EoE treatment effectiveness based solely on eosinophilic inflammation.

Furthermore, the study disclosed that several authors have affiliations with AstraZeneca, the manufacturer of benralizumab and the sponsor of the research. This disclosure is important for transparency regarding potential conflicts of interest.

In summary, the study underscores the complex nature of treating EoE, highlighting that a reduction in eosinophilic inflammation does not necessarily equate to symptomatic relief. This insight may influence future research directions and treatment strategies for this chronic condition, focusing not only on histologic outcomes but also on improving patients' quality of life by addressing their symptoms more effectively.