Long-term use of budesonide effective in microscopic colitis: ACG

The outcomes and safety of budesonide maintenance therapy in microscopic colitis (MC) are not well known. Adult residents of Olmsted County, Minnesota diagnosed with MC (2002-2019) and treated with budesonide were identified using the Rochester Epidemiology Project. The response was assessed at 12 +/- 4 weeks after initiation of therapy and defined as complete (resolution of diarrhoea), partial (≥50% improvement in a number of bowel movements), nonresponse (<50% improvement), and intolerance (discontinued due to side-effects). For safety outcomes, cases (budesonide maintenance) and MC controls (no budesonide therapy) were matched by gender and age at diagnosis (+/-2 years).

The results of the study are:

• A total of 450 patients were identified, of which 162 (36.0%) were treated with budesonide for induction of clinical remission
• Clinical outcomes for induction were as follows: 130 (80.2%) complete response, 22 (13.6%) partial response, 8 (4.9%) no response, and 2 (1.2%) intolerance. After induction, 96 (63.2%) had recurrence after discontinuation; 27 (28.1%) required further budesonide induction treatment without maintenance, 56 (58.3%) required long-term budesonide maintenance, and 13 (13.5%) were treated with other therapies.
• Of those receiving budesonide maintenance, all responded [55 (98.2%) complete, 1 (1.8%) partial].
• No patient stopped maintenance from adverse events. The median duration of follow-up was 5.6 years (0.3-18.9).
• There was no significant difference between cases and controls in the incidence of osteopenia/ osteoporosis, diabetes mellitus, hypertension, glaucoma, or cataracts.

Thus, the long-term use of budesonide in MC appears to be effective and generally well tolerated with limited adverse effects.

Reference:

Budesonide Maintenance in Microscopic Colitis: Clinical Outcomes and Safety Profile from a Population-Based Study by Tome, June et al. published in The American Journal of Gastroenterology.

doi: 10.14309/ajg.0000000000001774

Keywords:

Budesonide, Maintenance, Microscopic Colitis, Clinical Outcomes, Safety Profile, Population-Based Study, Tome, June Sehgal, Kanika Kamboj, Amrit K. Comstock, Bryce, Harmsen, William S. Khanna, Sahil, Pardi, Darrell S., The American Journal of Gastroenterology