A255 IPILIMUMAB INDUCED ENTEROCOLITIS: A SYSTEMATIC REVIEW AND META-ANALYSIS
Bibliographic record
Abstract
Ipilimumab is a human monoclonal cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody used to treat patients with stage III/IV melanoma and other solid tumors. Although treatment from an oncologic perspective may be successful, ipilimumab (a type of (CTLA-4 antibody) is associated with considerable drug-related adverse events, many serious events occurring in the gastrointestinal (GI) tract; including, enteritis, colitis, and enterocolitis. Until the introduction of ipilimumab and nivolumab (PD-1 antibody), no drugs have been reported to cause an enterocolitis that resembles inflammatory bowel disease (IBD), especially the chronic aspect of IBD. The objective of this study is to evaluate the risk of chronic (> 6 weeks) enterocolitis following ipilimumab administration. We searched MEDLINE, EMBASE, CENTRAL, and reference lists of relevant articles for citations. We included only randomized controlled trials comparing ipilimumab administration with placebo/standard of care/other active chemotherapy regimens. Two reviewers independently identified trials, extracted trial-level data and performed risk of bias assessments using the Cochrane Risk of Bias tool. The primary outcome was number of individuals with enterocolits both a) acute and b) chronic reported at longest follow-up. Meta-analysis was performed using a random-effects model. Of 1282 records identified, we included 7 unique trials enrolling a total of 4160 subjects. The mean age of subjects was 60 years. Five trials were evaluated as low risk of bias and two trials were evaluated as high risk of bias. Trials did not distinguish between acute enterocolitis and chronic enterocolitis. Trials did not distinguish between enteritis (small bowel involvement) and colitis. Ipilimumab was associated with an increased risk of enterocolitis (RR 11.93, 95% CI 1.51 to 94.17, I2 0%, 2 trials) and colitis (RR 10.29, 95% CI 5.92 to 17.88, I2 0%, 7 trials). Insufficient data exist to distinguish the risk of acute enterocolitis from the risk of chronic enterocolitis after ipilimumab use. Due to the serious impact of chronic enterocolitis on quality of life, future randomized controlled trials evaluating the safety of ipilimumab and other checkpoint inhibitors should be required to report gastrointestinal events in greater detail. 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 | 0.013 | 0.029 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.020 | 0.037 |
| Bibliometrics | 0.010 | 0.011 |
| 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) | 0.006 | 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".