Budesonide improves dysphagia in eosinophilic oesophagitis patients
Budesonide oral suspension (BOS) appears to produce improvements in dysphagia, easing pain with swallowing, in patients with eosinophilic oesophagitis (EoE), according to a secondary analysis of a phase II trial.
The analysis included 87 EoE patients, among whom 38 had been given placebo and 49 BOS at 2.0 mg twice daily for 12 weeks, in the prespecified modified intent-to-treat population. Researchers quantified symptoms using the dysphagia symptom questionnaire (DSQ) from baseline to week 12 of therapy, assessing solid-food dysphagia (Q1, Q2) and pain (Q4), and change in DSQ (Q2+Q3) and pain (Q4) scores from baseline.
At baseline, all patients reported dysphagia on at least 1 day (‘yes’ to Q2), and 92.0 percent stated that they needed to do something to make their food go down (‘yes’ to Q3). The number of patients reporting pain with swallowing (Q4, ‘mild’ to ‘very severe’) was similar in the placebo and BOS groups (81.6 percent each); mean DSQ scores were 29.0 and 29.3, respectively.
There were improvements seen in mean DSQ scores throughout treatment, with the changes being significantly greater with BOS only at week 12 (placebo vs BOS: week 4, −4.9 vs −7.4; p=0.265; week 8, −7.4 vs −10.3; p=0.288; week 12, −7.5 vs −14.3; p=0.01). Results were similar for pain (Q4) scores, although the changes did not significantly differ between treatment groups (placebo vs BOS: week 4, −2.5 vs −3.3; p=0.484; week 8, −3.0 vs −4.9; p=0.066; week 12, −3.1 vs −4.9; p=0.109).
Higher DSQ and DSQ+pain scores were associated with presence of other symptoms (eg, regurgitation) and physician-rated severity. Meanwhile, greater improvements in DSQ and DSQ+pain scores were seen in patients with either a histologic or endoscopic response than in those without a response.
The present data suggest the inclusion of pain with swallowing as part of the clinical assessment of patients with EoE, the researchers said. Pain evaluation may facilitate characterization of the disease and serve as a marker of more generalized symptoms, which should further guide clinical management.