Orodispersible budesonide delivered specifically to the oesophagus as a tablet was effective in inducing clinical and histological remission in patients with eosinophilic oesophagitis, according to the data from the EOS-2 trial, reported by Prof. Alfredo Lucendo (Tomelloso General Hospital, Spain) .
EOS-2 aimed to test the efficacy of a 6-week open-label induction treatment with oral budesonide (1 mg, twice daily) in a large prospectively treated cohort of eosinophilic oesophagitis patients, which was used as a feeding arm for the further double-blind maintenance phase of the EOS-2 trial, not reported here. Prof. Lucendo presented the induction phase data.
Orodispersible budesonide targets eosinophilic inflammatory infiltrate by preventing antigen-stimulated secretion of proinflammatory signal molecules into the oesophageal epithelium. The drug is dissolved against the hard palate and swallowed slowly. The study recruited 181 adults with clinical and histological active eosinophilic oesophagitis refractory to standard doses of various proton pump inhibitors, who were then treated in the 6-week induction phase with budesonide. The primary endpoint and basis for later randomisation into the double-blinded maintenance phase was based on both clinical and histological factors, requiring patients to achieve both clinical remission (≤2 points on numerical rating scales (0-10 points) each for dysphagia and odynophagia on each of the 7 days prior to end-of-treatment) in addition to histological remission (peak eosinophil count <16 eosinophils/mm2 high power field).
At 6 weeks, 69.6% (126/181) of patients were in complete clinical and histological remission. Compared to baseline, oral budesonide twice daily achieved all assessed clinical, endoscopic, and histological endpoints.
Prof. Lucendo underscored that the findings from EOS-2 recapitulated the results from the smaller double-blinded, placebo-controlled EOS-1 study (n=88; 58% achieved complete remission in the budesonide arm vs 0% in the placebo arm), but in a larger independent cohort.
- Lucendo A et al. UEG Week 2019, Abstract OP091.