Budesonide for maintenance of remission in Crohnʼs disease: A systematic review and meta-analysis for the Cochrane Collaboration.
Bibliographic record
Abstract
Corticosteroids have been shown to be effective for induction, but not maintenance of remission in Crohn's disease (CD). Significant concerns exist regarding their risk for adverse events, particularly when used for long treatment courses. Budesonide, a glucocorticoid with limited systemic bioavailability due to extensive first-pass hepatic metabolism, has been shown to be effective for induction of remission in CD. This systematic review and meta-analysis examined the efficacy and safety of budesonide for maintenance of remission in CD. MEDLINE, EMBASE, other electronic databases, reference lists of articles, and conference proceedings were searched. Trials comparing budesonide to a control treatment or comparing two doses of budesonide were included. The primary outcome was maintenance of remission up to 12 months following enrolment. Secondary outcomes included: time to relapse, mean change in CDAI, adverse events and study withdrawal. Two independent investigators reviewed studies for eligibility, and extracted the data. For the meta-analysis, a random or fixed effects model was chosen based on an assessment of heterogeneity, and studies were weighted using the Der-Simonian & Laird or the Mantel-Haenszel method accordingly. Eleven studies were included in the review. Budesonide 6 mg daily was no more effective than placebo for maintenance of remission at 3 months (RR 1.25,95% CI 1.00-1.58, P=0.05), 6 months (RR 1.15, 95% CI 0.95-1.39, P=0.14), or 12 months (RR 1.13, 95% CI 0.94-1.35, P=0.19). Budesonide was not more effective than weaning doses of prednisolone for maintenance of remission at 12 months (RR 0.79, 95% CI 0.55-1.13, P=0.20), but was better than mesalamine (RR of remission 2.51, 95% CI 1.03-6.12, P=0.04). Budesonide 3 mg daily was more effective than placebo at 3 months (RR 1.31,95% CI 1.03-1.67, P = 0.03), likely due to either selection bias or the residual effects of the methods used to induce remission. This benefit was not sustained at 6 months (RR 1.10, 95% CI 0.81-1.50, P=0.53), or 12 months (RR 1.04, 95% CI 0.84-1.30, P = 0.70). No differences were detected based on the different formulations or doses of budesonide or methods used to induce remission. The use of budesonide 6 mg resulted in slight improvements in CDAI scores at 12 months (WMD -23.49, 95% CI -46.65 to -0.32, P=0.05) and mean time to relapse of disease (WMD 59.93 days, 95% CI 19.02-100.84, P=0.004). Adverse events were more frequent in patients treated with 6 mg of budesonide compared with placebo (RR 1.49, 95% CI 1.01-2.19, P=0.05). Abnormal adrenocorticoid stimulation tests were seen more frequently in patients receiving both 6 mg daily (RR 2.88, 95% CI 1.72-4.82, P<0.0001) and 3 mg daily (RR 2.73, 95% CI 1.34-5.57, P=0.006) compared with placebo. Budesonide is not more effective than placebo for maintenance of remission in CD. Some modest benefits of budesonide are noted including lower CDAI scores and longer time to disease relapse. However, these benefits are offset by higher treatment-related adverse event rates and more frequent adrenocorticoid suppression in patients receiving budesonide. Therefore, budesonide is not recommended for maintenance of remission in Crohn's disease.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.016 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.016 | 0.024 |
| Bibliometrics | 0.007 | 0.006 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".