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This integrated safety assessment of six phase 1–3 clinical trials was carried out to investigate the safety of Budesonide oral suspension [BOS] in patients with eosinophilic oesophagitis (EoE).
Budesonide oral suspension (swallowed topical corticosteroid) is a well-tolerated therapy at different doses in patients with eosinophilic oesophagitis.
This integrated safety assessment of six phase 1–3 clinical trials was carried out to investigate the safety of Budesonide oral suspension [BOS] in patients with eosinophilic oesophagitis (EoE).
The safety data were consolidated from 6 trials:
An assessment of adverse events (AEs), lab testing, bone mineral density, and adrenal AEs was done. The exposure-adjusted occurrence rates were used to assess the AEs.
Five-hundred and fourteen participants were considered (BOS 2.0 mg given twice daily, number of participants, n = 292; BOS at any dose, n = 448; placebo, n = 168) which totalled 93.7 for BOS 2 mg, 122.4 for BOS at any dose and 25.0 for placebo participant-years of exposure (PY). Compared to placebo, a higher percentage of treatment-emergent AEs (TEAEs) and AEs of special interest were reported with the use of BOS; but, these were of mild/moderate severity.
The most frequently noted AEs of special interest (exposure-adjusted incidence rates [per 100 person-years]) in the three groups have been described (Table 1):
Adrenal AEs were more common with BOS 2 mg twice daily and BOS any dose compared to placebo. The treatment-emergent AEs and AEs of special interest linked with the study’s investigational therapy or leading to withdrawal were rare.
BOS (Investigational formulation of Budesonide) was found to be well-tolerated; with the majority of treatment-emergent AEs with BOS as mild/moderate in nature.
Alimentary Pharmacology and Therapeutics
Safety of an investigational formulation of budesonide (budesonide oral suspension) for eosinophilic oesophagitis: an integrated safety analysis of six phase 1–3 clinical trials
Ikuo Hirano et al.
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