Induction with budesonide does little to speed up mucosal healing in coeliac disease

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

The study randomized 37 patients to receive effervescent budesonide (starting dose 9 mg/day; n=19) or placebo (n=18) for 10 weeks. Efficacy endpoints including Marsh grading and quantitative duodenal morphometry were assessed after 8 and 52 weeks. Multiple clinical measures and adverse events were also evaluated.

Week-8 results revealed that the budesonide and placebo arms had similar mucosal response (Marsh 0 or 1: 37 percent vs 28 percent, respectively) and remission (Marsh 0: 32 percent vs 17 percent). At week 52, there were still no significant difference observed in either response (63 percent vs 44 percent) or remission (42 percent vs 33 percent; p>0.32 for all).

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

The same was true for clinical measures and adverse events, with data being comparable between the budesonide and placebo groups. None of the patients developed corticosteroid adverse effects.

Meanwhile, posthoc analysis revealed that only one out of nine patients who achieved mucosal remission at week 8 had hyperplastic crypts with total villous atrophy (Marsh 3C) at diagnosis as opposed to 18 out of 23 patients overall (p<0.001). Furthermore, the mean villous-height:crypt-depth ratio was 1.06 vs 0.46, respectively (p=0.005).

The posthoc data suggest that mucosal remission at week 8 could be associated with less severe histological lesions at diagnosis.