A96 ADALIMUMAB FOR MAINTENANCE OF REMISSION IN CROHN’S DISEASE
Bibliographic record
Abstract
Maintenance of remission of Crohn’s disease (CD) is a clinically important goal, as disease relapse can negatively affect quality of life. The objective of this systematic review was to assess the efficacy and safety of adalimumab for maintenance of remission in patients with quiescent CD. EMBASE, MEDLINE, CENTRAL and the Cochrane IBD Group Specialized Register were searched from inception to April 2018. Randomized controlled trials (RCTs) comparing adalimumab to placebo or an active comparator were considered for inclusion. Data were analyzed on an intention-to-treat basis. Risk ratios (RR) and corresponding 95% confidence intervals (95% CI) were calculated for dichotomous outcomes. The primary outcome was the number of patients who relapsed. Secondary outcomes were failure to maintain clinical response, endoscopic remission, endoscopic response, histological remission and adverse events. Bias was assessed using the Cochrane risk of bias tool. GRADE was used to assess the overall quality of evidence supporting the primary outcome. Seven RCTs (n=1229) were included. Five trials were rated low risk of bias and two trials were rated as unclear risk of bias. Three studies comprising 683 patients included relapse at 52–56 weeks as an endpoint. Fifty-nine percent (252/430) of patients treated with adalimumab relapsed compared with 86% (217/253) of patients receiving placebo (RR 0.69, 95% CI 0.63–0.76, P<0.05; moderate quality evidence). Two RCTs (302 patients) reported the number of patients who failed to maintain clinical or endoscopic relapse at 52–56 weeks among those who received prior TNF antagonist therapy. Sixty-nine percent (129/186) of adalimumab patients relapsed compared with 93% (108/116) receiving placebo (RR 0.76, 95% CI 0.68–0.84, P<0.05; high quality evidence). Two RCTs including 562 patients included relapse at 24–26 weeks as an endpoint. Fifty-one percent (192/374) of patients who received adalimumab relapsed compared with 75% (149/188) of those who received placebo (RR 0.63, 95% CI 0.49–0.81, P<0.05; low quality evidence). Serious adverse events were seen in 8% (52/643) of patients who received adalimumab and 14% (53/368) of patients who received placebo (RR 0.55, 95% CI 0.38–0.79, P<0.05; low quality evidence) and withdrawal due to adverse events was reported in 7% (45/643) of adalimumab patients compared to 13% (48/369) of placebo patients (RR 0.57, 95% CI 0.39–0.83, P<0.05; low quality evidence) between the adalimumab and placebo groups. Adalimumab is an effective therapy to maintain clinical remission in patients with CD. It is also effective in patients who have previously been treated with TNF antagonists. Future research should continue to explore factors that influence initial and subsequent biologic selection for patients with moderate to severe CD. None
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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 | 0.008 | 0.022 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.008 | 0.009 |
| Bibliometrics | 0.006 | 0.005 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 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".