MESSINA
Trial question
What is the role of benralizumab in patients with eosinophilic esophagitis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 210
210 patients (53 female, 157 male)
Inclusion criteria: patients aged 12-65 years with symptomatic and histologically active eosinophilic esophagitis
Key exclusion criteria: other gastrointestinal disorders; esophageal dilation performed in the past 8 weeks; hypereosinophilic syndrome; active liver disease; concomitant use of immunosuppressive medications
Interventions
N=103 benralizumab (subcutaneous dose of 30 mg every 4 weeks)
N=107 placebo (matching placebo every 4 weeks)
Primary outcome
Histologic response at week 24
87.4
6.5
87.4 %
65.6 %
43.7 %
21.9 %
0.0 %
Benralizumab
Placebo
Significant
increase ▲
NNT = 1
Significant increase in histologic response at week 24 (87.4% vs. 6.5%; AD 80.8%, 95% CI 72.9 to 88.8)
Secondary outcomes
No significant difference in reduction in Dysphagia Symptom Questionnaire score at week 24 (12.1 points vs. 15.1 points; AD -3 points, 95% CI -7.4 to 1.4)
Significant increase in reduction in esophageal intraepithelial eosinophil count at week 24 (94.8% vs. -1.4%; ARD 96.2, 96% CI 77.9 to 114.5)
Significant increase in treatment response (43.7% vs. 4.7%; AD 39%, 95% CI 28.6 to 49.4)
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients aged 12-65 years with symptomatic and histologically active eosinophilic esophagitis, benralizumab was superior to placebo with respect to histologic response at week 24.
Reference
Marc E Rothenberg, Evan S Dellon, Margaret H Collins et al. Eosinophil Depletion with Benralizumab for Eosinophilic Esophagitis. N Engl J Med. 2024 Jun 27;390(24):2252-2263.
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