Editorial: safety of topical steroids designed specifically for eosinophilic oesophagitis – new data bring new questions. Authors' reply

Abstract

We thank Drs. Visaggi and Savarino for their interest in our study and insightful comments. 1,2 Our article provides a comprehensive overview of the safety outcomes following long-term treatment (up to 208 weeks) with budesonide oral suspension (BOS) in patients with eosinophilic oesophagitis (EoE). In our integrated safety analysis, BOS was well-tolerated, including in patients receiving the highest dose of BOS assessed to date (2.0 mg twice daily [b.i.d.]).We would like to emphasise that exposure-adjusted incidence rates per 100 participant-years were used to account for differences in treatment duration. Rates were similar for participants receiving BOS 2.0 mg b.i.d., BOS (any dose), and placebo for infections (133.5, 154.4, and 136.2), gastrointestinal effects (84.3, 80.9, and 92.1) and central nervous system (CNS)/mood effects (54.5, 63.7, and 52.1), and were only slightly higher for BOS than placebo for adrenal effects (44.8, 34.3, and 24.0). Importantly, most adverse events (AEs)were not serious, were not considered related to study drug and did not result in study or study drug discontinuation. Only one serious (equal); methodology (equal); project administration (equal); supervision (equal); writing -original draft (equal); writing -review and editing (equal). Mena Boules: Conceptualization (equal); data curation (equal); investigation (equal); methodology (equal); project administration (equal); supervision (equal); writing -original draft (equal); writing -review and editing (equal). Siddharth Bhatia: Conceptualization (equal); data curation (equal); investigation (equal); methodology (equal); project administration (equal); supervision (equal); writing -original draft (equal); writing -review and editing (equal). Nirav K. Desai: Conceptualization (equal); data curation (equal); investigation (equal); methodology (equal); project administration (equal); supervision (equal); writing -original draft (equal); writing -review and editing (equal).