A151 COMPARABLE NEONATAL AND PREGNANCY-RELATED OUTCOMES BETWEEN EARLY AND LATE DISCONTINUATION OF BIOLOGICS IN PREGNANT WOMEN WITH INFLAMMATORY BOWEL DISEASE
Bibliographic record
Abstract
Abstract Background Inflammatory bowel disease (IBD) disease activity during pregnancy is related to adverse neonatal and pregnancy-related outcomes. Biologics are used to suppress disease activity, however, since there is known transplacental passage, the American Gastroenterology Association (AGA) recommends timing the final dose with drug-specific half-lives although there is little evidence demonstrating adverse outcomes. Aims We aim to assess the safety of early versus late discontinuation of biologics according to drug-specific half-lives by comparing various neonatal and pregnancy-related outcomes. Methods This is a REB approved single-center retrospective cohort study on all patients with IBD ≥18 years of age on a biologic agent prior to conception, have a documented final dose during pregnancy, and were seen at Mount Sinai Hospital from 2016–2019. Neonate and pregnancy-related outcomes were compared amongst the two groups (Table 1) using the student’s t-test (birthweight, gestational age, Apgar scores) and Fischer’s exact test (NICU admission, congenital anomalies, GBS, chorioamnionitis) analyzed in SPSS Version 27. The level of significance was set at p<0.05. Results We identified 53 patients on biologics pre-conception. 26 patients had a documented final dose (19 early cohort, 7 late cohort) and were included in the analysis. Aside from mean birthweight (3014 vs 3561 g, p=0.036), there were no statistically significant differences between the early and late cohorts for gestational age (37.4 vs 39.0 weeks, p=0.20), 1- and 5-min Apgar scores (7.8 vs 8.8, p=0.37 and 8.5 vs 9.0, p=0.49), NICU admissions (p=0.54), congenital anomalies (p=1.00), GBS (p=0.55), and chorioamnionitis (p=1.00). Conclusions Overall, our study suggests that early and late discontinuation of biologics have comparable safety profiles based on various neonatal and pregnancy-related outcomes. In fact, we see significantly higher birthweights in the late cohort along with a consistent (non-statistically significant) trend of later gestational ages, and higher Apgar scores. Further, no cases involving NICU admissions, congenital abnormalities, GBS, or chorioamnionitis were seen in the late cohort. Next, we hope to verify our findings by conducting a prospective cohort study with a larger study population and more comprehensive data collection. This will provide higher statistical power and allow for additional subgroup analyses based on objective disease activity (FCP levels) and therapeutic drug monitoring (serum drug levels). Funding Agencies 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 | 0.001 | 0.005 |
| 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 | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 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".