Letter: the definition of budesonide dependence in microscopic colitis—authors’ reply

SIRS, We appreciate the comments of Drs. Fernandez-Banares and Gisbert on our article. We agree that our definition of budesonide dependence was broad, namely recurrence of diarrhoea after budesonide discontinuation. We also agree with their clinically important recommendation that maintenance budesonide should be used at the lowest effective dose, to minimise the risk of steroid-related side effects and cost, as noted in reviews from the USA and Europe. An average dose of 4.5 mg/d was more effective than placebo in a randomised trial, and in clinical practice, doses as low as 3 mg/d or even 3 mg every other day may be effective for maintenance. The Spanish Microscopic Colitis Group demonstrated the effectiveness of this strategy in a group of patients with collagenous colitis, and also reported that a subset of patients requires higher doses. In this study, only NSAID use at diagnosis was predictive of the need for higher maintenance doses of budesonide. We aimed to study doseresponse in our cohort treated with maintenance budesonide, but in a substantial proportion of patients in this retrospective study, we only knew the starting dose of budesonide but not the lowest dose used to maintain remission. We share the concerns of Fernandez-Banares and Gisbert that higher doses of budesonide over the long term may be associated with higher risk of steroid-related side effects, but we are not aware of robust evidence that higher doses (ie 6 mg/d) are riskier than lowdose budesonide (ie 3 mg/d). In the absence of such data, we prefer a broader definition of budesonide dependence to include any patient requiring long-term treatment for symptom control. As recommended previously, patients on maintenance budesonide should be monitored for the adverse events, particularly those on higher doses. Furthermore, it is not clear that maintenance treatment with immunomodulators is safer than budesonide, even at a dose of 69 mg/d, and therefore we tend to restrict use of immunomodulators to patients who are actually experiencing a side effect on budesonide.