Induction Therapy with Budesonide Exerts No Significant Effect on Mucosal Healing in Coeliac Disease Patients

A study has discovered that induction therapy with budesonide in coeliac disease patients, who are concurrently initiated on a gluten-free diet, exerts no significant effect on mucosal healing.

Induction Therapy with Budesonide Exerts No Significant Effect on Mucosal Healing in Coeliac Disease Patients
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Research randomly selected 37 patients to receive effervescent budesonide, with starting dose of 9 mg/day for 19 patients, and placebo for 18 patients good for 10 weeks monitoring. Efficacy endpoints including Marsh grading and quantitative duodenal morphometry were evaluated after 8 and 52 weeks. Multiple clinical measures and adverse events were also assessed.

Outcomes for week 8 showed that the budesonide and placebo arms had similar mucosal response and remission. At week 52, there was still no significant difference observed in either response or remission.

Similarly, no between-group difference was observed in the improvement from baseline in villous-height: crypt-depth ratio.

Same was true for clinical measures and adverse events, with data being comparable between budesonide and placebo groups. There were none of the patients developed corticosteroid adverse effects.

On the other hand, posthoc analysis showed that only one out of 9 patients who achieved mucosal remission at week 8 had hyperplastic crypts with total villous atrophy at diagnosis as opposed to 18 out of 23 patients overall. Moreover, the mean villous-height: crypt-depth ratio was 1.06 vs 0.46, correspondingly.

Posthoc data suggest that mucosal remission at week 8 could be correlated with less severe histological lesions at diagnosis according to researchers.

 

Source: Aliment Pharmacol Ther2021;doi:10.1111/apt.16446

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