P457 Biological interventions for induction and maintenance of mucosal healing in ulcerative colitis: A Cochrane systematic review
Bibliographic record
Abstract
The number of biologics for ulcerative colitis (UC) is rapidly expanding and mucosal healing (MH) is a salient endpoint against which to gauge their efficacy. In this Cochrane review, we synthesised the randomised controlled trial (RCT) data on biologics for inducing and maintaining MH in UC. We searched MEDLINE, EMBASE, Cochrane Library and the Cochrane IBD Group Specialised Trials Register to October 2017 for RCTs investigating biologics for inducing and/or maintaining MH in UC at 4–26 and >26 weeks, respectively. Secondary outcomes were endoscopic response (ER), safety and quality of life (QOL). Pooled risk ratios (RR) were determined using a random-effects model. The quality of the evidence was rated with GRADE. The search yielded 13 induction trials (eight low, four unclear, one high-risk of bias). Infliximab (IFX), adalimumab (ADA), golimumab (GOL) and vedolizumab (VDZ) were superior to placebo (PBO) for inducing MH at 6–8 weeks (RR 1.8, 95% CI 1.5–2.1, n = 979, high quality for IFX; RR 1.3, 95% CI 1.1–1.5, n = 940, moderate quality for ADA; RR 1.5, 95% CI 1.2–1.8, n = 1194, high quality for GOL; RR 1.7, 95% CI 1.3–2.3, n = 555, moderate quality for VDZ). IFX plus azathioprine (AZA) was superior to AZA (RR 1.7, 95% CI 1.2–2.4, n = 154, low quality). No difference was seen between IFX and ADA in a single trial (RR 1.0, 95% CI 0.51–2.0, n = 50, very low quality). Seven maintenance trials were identified (all low risk of bias). The ability of a biologic to maintain MH achieved during induction was examined in one ADA trial; no difference was observed between ADA and PBO (RR 1.3, 95% CI 0.90–1.9, n = 180, low quality). Analyses including all randomised patients (regardless of MH status at induction completion) demonstrated higher MH rates at 1 year with IFX, ADA, GOL and VDZ vs. PBO (RR 2.5, 95% CI 1.7–3.8, n = 364 for IFX; RR 1.7, 95% CI 1.2–2.2, n = 767 for ADA; RR 1.6, 95% CI 1.2–2.1, n = 332 for GOL; RR 2.7, 95% CI 1.9–3.9, n = 373 for VDZ; moderate quality for all). ADA and VDZ were effective amongst anti-TNF-naive patients for induction only. The same was true of ADA for maintenance, while VDZ’s maintenance benefit was observed in bio-naive and bio-exposed patients. The IFX and GOL data pertain to anti-TNF-naive patients only. Adverse event rates were similar between groups. All 4 biologics were associated with QOL improvements. Moderate-to-high quality evidence supports the efficacy of IFX, ADA, GOL and VDZ for inducing MH in moderate-to-severe UC. The existing evidence is insufficient to assess their ability to maintain MH achieved during induction. However, all four are associated with higher rates of MH at 1 year than PBO when all randomised patients, irrespective of MH status at the end of induction, are considered.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.006 | 0.028 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.013 | 0.010 |
| Bibliometrics | 0.012 | 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) | 0.015 | 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".