P365 Biological interventions for induction and maintenance of mucosal healing in Crohn’s disease: A Cochrane systematic review
Bibliographic record
Abstract
Clinical trials of biologics in Crohn’s disease (CD) have focused on clinical outcomes. Their ability to achieve mucosal healing (MH) is less clear. In this Cochrane review, we synthesised the randomised controlled trial (RCT) data on biologics for inducing and maintaining MH in CD. MEDLINE, EMBASE, Cochrane Library (CENTRAL) and the Cochrane IBD Group Specialised Trials Register were searched to October 2017 for RCTs examining biologics for inducing and/or maintaining MH in CD at 4–26 and >26 weeks, respectively. Secondary outcomes were endoscopic response (ER), safety and quality of life (QOL). Pooled risk ratios (RR) were calculated using a random-effects model. The quality of the evidence was rated using GRADE. The search yielded 7 induction trials (5 low, 2 unclear risk of bias). Infliximab (IFX) was superior to placebo (PBO) for inducing MH at week 10 (RR 8.4, 95% CI 1.2–61, n = 74, low quality), and IFX mono- and combination therapy with azathioprine (AZA) were superior to AZA for inducing MH at week 26 (RR 1.9, 95% CI 1.1–3.1, n = 218, low quality, and RR 2.7, 95% CI 1.7–4.3, n = 232, moderate quality). MH rates did not differ significantly between adalimumab (ADA) and PBO-treated patients, but ADA users were more likely to achieve CDEIS ≤4 at week 12 (RR 1.9, 95% CI 1.2–3.0, n = 123, low quality). Neither natalizumab (RR 2.8, 95% CI 0.4–20, n = 50, low quality), nor ustekinumab (UST) (RR 2.1, 95% CI 0.81–5.4, n = 302, low quality) was superior to PBO for inducing MH, but UST users displayed significantly greater SES-CD reductions in one study (low quality). The search identified 3 maintenance trials, each examining a different biologic (2 low, one high risk of bias). Neither IFX nor ADA was superior to PBO for maintaining MH achieved during induction, but patient numbers were extremely small. Comparable data were not available for UST. Amongst all randomised patients (regardless of MH status at induction completion), only ADA was associated with higher 1-year MH rates than PBO (RR 30.5, 95% CI 1.9–499, moderate quality for ADA; RR 2.4, 95% CI 0.94–6.4, low quality for IFX; RR 2.2, 95% CI 0.86-5.6, very low quality for UST). All 3 biologics displayed a significant benefit for ER at 1 year. Adverse event rates were similar between groups, but one case of progressive multifocal leukoencephalopathy was observed with natalizumab. IFX and UST were associated with improved QOL. The evidence supports the efficacy of IFX for inducing MH (low-to-moderate quality), and of ADA and UST for inducing ER (low quality), in CD. ADA was associated with higher maintenance MH rates than PBO at 1 year, with ADA, IFX and UST displaying significantly higher rates of ER. There is no RCT evidence for certolizumab or vedolizumab.
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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 | 0.028 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.013 | 0.011 |
| Bibliometrics | 0.013 | 0.012 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.014 | 0.001 |
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".