Mepolizumab does not appear to reduce the symptoms of dysphagia as compared with placebo in the treatment of individuals with eosinophilic oesophagitis (EoE), although the drug helps reduce eosinophil counts and endoscopic severity, according to a study.
The study included 66 patients with EoE and dysphagia symptoms (per EoE Symptom Activity Index [EEsAI]) who were 16–75 years of age. These patients were randomly assigned to receive 3 months of mepolizumab 300 mg monthly or placebo. Researchers assessed the change in EesAI from baseline to month 3 as the primary outcome. Secondary outcomes included histological, endoscopic, and safety parameters.
Then, the patients who were initially assigned to mepolizumab treatment continued with 300 mg monthly for 3 additional months (mepo/mepo), while those who were assigned to placebo started mepolizumab 100 mg monthly (pbo/mepo). Outcomes were reassessed at month 6.
Of the patients, 64 completed the month 3 assessment and 56 completed month 6. At month 3, the primary endpoint did not significantly differ between the two treatment groups, with EesAI decreasing by 15.4 points with mepolizumab and 8.3 points with placebo (p=0.14).
Meanwhile, mepolizumab treatment led to a greater decrease in peak eosinophil counts (113 to 36 vs 146 to 160; p<0.001) and higher histological responses (<15 eos/hpf: 42 percent vs 3 percent; ≤6 eos/hpf: 34 percent vs 3 percent; p<0.001 and p=0.02, respectively). The change in EoE Endoscopic Reference Score at month 3 was also larger with mepolizumab.
At month 6, EesAI decreased by 18.3 points for mepo/mepo and by 18.6 for pbo/mepo (p=0.85). In terms of safety, injection-site reactions were the most common adverse events.