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Randomised clinical trial: adjunctive induction therapy with oral effervescent budesonide in newly diagnosed coeliac disease
Author(s) -
Newnham Evan D.,
ClaytonChubb Daniel,
Nagarethinam Meena,
Hosking Patrick,
Gibson Peter R.
Publication year - 2021
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.16446
Subject(s) - medicine , budesonide , adverse effect , placebo , gastroenterology , coeliac disease , clinical trial , corticosteroid , disease , pathology , alternative medicine
Summary Background The healing of the mucosal lesion in patients with coeliac disease is slow. Aim To determine whether concurrent budesonide and gluten‐free diet hasten small bowel healing and symptomatic improvement in patients with newly diagnosed coeliac disease. Methods In a pilot, randomised, double‐blind trial, effects on Marsh grading and quantitative duodenal morphometry of 10 weeks' effervescent budesonide (initially 9 mg/day) or placebo were assessed after 8 and 52 weeks. Multiple clinical measures and adverse events were assessed. Results Nineteen patients were randomised to budesonide and 18 to placebo. No differences (all P > 0.32) were observed for the week‐8 mucosal response (Marsh 0 or 1) (budesonide: 37% vs placebo: 28%), week‐8 remission (Marsh 0) (32% vs 17%), week‐52 response (63% vs 44%) and week‐52 remission (42% vs 33%). Likewise, the improvement from baseline in villous‐height : crypt‐depth ratio was not different for the treatment groups. There were no statistically significant differences in clinical measures or adverse events between the treatment groups. No corticosteroid adverse effects were observed. In a post hoc analysis of all patients, Marsh 3C was present at the diagnostic biopsy in 1/9 achieving mucosal remission at 8 weeks versus 18/23 not ( P < 0.001) and mean villous‐height : crypt‐depth ratio was 1.06 (SD: 0.73) versus 0.46 (0.38) ( P = 0.005). Conclusions In this pilot trial, induction therapy with budesonide had no significant effect on mucosal healing in patients with coeliac disease concurrently initiated on a gluten‐free diet. Mucosal remission at 8 weeks occurred in approximately one in four patients and was associated with less severe histological lesions at diagnosis.