S791 Impact of Biologic Therapies on Risk of Major Adverse Cardiovascular Events in Crohn’s Disease: Systematic Review and Meta-Analysis of Randomized Controlled Trials
Bibliographic record
Abstract
Introduction: Biologic therapies are efficacious in inducing response and remission in patients with moderate to severe Crohn’s Disease (CD); however, no previous systematic reviews investigated risk of major adverse cardiovascular events (MACEs). The aim of this systematic review and meta-analysis is to estimate the risk of MACEs in adult patients with CD treated with biologic therapies. Methods: We systematically searched Medline, Cochrane Central Register of Controlled Trials, Scopus, and Embase databases up to March 2022 to identify eligible studies that assessed the risk of MACEs in adult patients (age ≥18 years) with CD on biologic therapies. Only phase 3, active-comparator or placebo controlled randomized trials (RCTs) were included in the analysis. Our primary outcome was the rate of MACEs observed in patients receiving biologic therapies during induction and maintenance phases of RCTs. Random effects model was used to calculate pooled odds ratios (ORs) and 95% CIs and I2 statistics was used to assess heterogeneity. Results: Twenty-nine RCTs involving 12196 patients with CD were included in our systematic review and meta-analysis. There was no evidence of statistical heterogeneity across the studies using the I2 statistic (I2=0). Biologic therapies were not associated with increased risk of MACEs during induction [infliximab (OR 0.63, 95% CI 0.07–6.14), adalimumab (OR 0.72, 95% CI 0.07–6.96), ustekinumab (OR 0.50, 95% CI 0.03–8.04), natalizumab (OR 0.50, 95% CI 0.05–4.86), vedolizumab (OR 0.53, 95% CI 0.06–5.12), certolizumab (OR 1.90, 95% CI 0.16–22.76) and risankizumab (OR 0.34, 95% CI 0.01–17.12)]. Additionally, there was no statistically significant difference in risk of MACEs associated with the use of biologic therapies during maintenance compared to placebo [infliximab (OR 0.72, 95% CI 0.01–5.10), adalimumab (OR 0.80, 95% CI 0.08–7.77), ustekinumab (OR 1.53, 95% CI 0.06–37.71), natalizumab (OR 1.02, 95% CI 0.02–51.59), vedolizumab (OR 0.70 95% CI 0.04–11.53), and certolizumab (OR 1.91, 95% CI 0.16–22.83]. Conclusion: Although pervious systematic reviews have studied the efficacy of biologic therapies in CD, major adverse cardiovascular events (MACEs), which are important safety outcomes, have not been addressed. In our study, we found that the use of biologic therapies among adult patients with Crohn’s disease was not associated with increased risk of MACEs. However, patient level data were lacking and meta-regression analyses were not performed to adjust for confounding factors. (Figure)Figure 1.: A. Forest plot showing risk of MACEs in patients receiving biologic therapies for the induction of remission in randomized controlled trials B. Forest plot showing risk of MACEs in patients receiving biologic therapies for the maintenance of remission in randomized controlled trials
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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 | 0.024 | 0.067 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.022 | 0.043 |
| Bibliometrics | 0.010 | 0.010 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".