The Influence of Vedolizumab on Postoperative Outcomes in IBD Patients Undergoing Abdominal Surgery
Bibliographic record
Abstract
Introduction: Vedolizumab (VDZ) is approved to treat both Crohn's disease (CD) and ulcerative colitis (UC), and has a favorable safety profile. Its effectiveness and safety in the peri-operative setting is unknown. We describe our experience with VDZ in inflammatory bowel disease (IBD) patients (pts) who underwent abdominal surgery. Methods: We reviewed the medical records of pts at our tertiary center who received VDZ within 2 months prior to IBD-associated abdominal surgery from August 2014 to March 2016. Type of surgery, concomitant medications and any reported adverse events (AEs) and serious AEs (SAEs) after surgery were recorded from three different time points: post-surgical hospitalization, 4 weeks post-op and 6 months post-op. Standard clinical trial definitions of AEs were used. We also conducted a case-control analysis comparing pts receiving VDZ to patients receiving infliximab pre-operatively, matched based on Montreal classification, surgery type and age at surgery. Statistical analysis using Fisher's exact test was performed.Table 1: Rates of Adverse Events, Serious Adverse Events, and Infectious Complications in IBD Patients Receiving Vedolizumab.Results: 23 pts were included (14 CD, 9 UC) for the cohort analysis, including 19 who had ostomy creation and 4 with bowel resection and anastomosis. 2/23, 7/23 and 6/14 pts experienced a SAE in the hospital post-operatively, by 4 weeks or by 6 months, respectively. SAEs included intra-abdominal abscess (n=4), small bowel obstruction (n=4), and mesenteric thrombosis (n=1) (Table). Rates of infectious complications experienced by our cohort were 8.7% (n=2) during post-surgical hospitalization, 13.0% (n=3) within the 4 weeks and 28.6% (n=4) by 6 months (Figure 1). Infectious complications included wound infection, intra-abdominal/anorectal/urogenital abscess, sepsis, urogenital infection and C. difficile infection. The case control analysis compared 12 pts receiving VDZ to 20 pts receiving infliximab. Although there were numerically more infectious complications with infliximab, no statistically significant differences were seen in serious adverse events or infectious complications at all time points (Figure 2).Figure 1Figure 2Conclusion: We describe the AEs of IBD pts receiving VDZ peri-operatively, and perform a case-control analysis comparing these pts to those who receive anti-TNF therapy. No differences regarding SAEs or infectious complications were seen in the case control analysis when VDZ was compared to infliximab. The main limitations of this study are the retrospective setting and the small sample size.
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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 | 0.001 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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".