Gestational Exposure to Natalizumab and Pregnancy Outcomes_Results From a Prospective Cohort with Relapsing Remitting Multiple Sclerosis (P4.156)
Bibliographic record
Abstract
Objective In this study we aimed to determine the fetal safety of exposure to natalizumab (Tysabri®) during pregnancy in women with Relapsing Remitting Multiple Sclerosis (RRMS) Background Women with RRMS planning pregnancies are advised to discontinue treatment 3 months prior to conception. In women who have excellent control of their disease activity with natalizumab, discontinuation of treatment before becoming pregnant poses a dilemma as they are at a high risk of experiencing severe relapse(s) requiring steroid treatment during pregnancy. Methods 97 Women with RRMS referred from different centers in Germany were followed prospectively via telephone calls, after confirmed exposure to natalizumab during pregnancy. Birth outcomes in the natalizumab-exposed group, were compared to a comparison group of women with no exposure to teratogens (N=97) in pregnancy, and a disease-matched group of women with MS (N=79) with or without exposure to other disease modifying drugs during pregnancy. Results A total of 77, 69 and 92 live births occurred in the natalizumab, diseased matched and healthy comparison groups respectively. The rates of major malformations (P=0.73), low birth weight (<2500g) (P=1.0), premature birth (P=0.48) did not differ significantly. The miscarriage rate was higher (P=0.002) and the birth weights lower (P=0.001), among the natalizumab and disease- matched group, as compared to the healthy controls, however there was no difference between the natalizumab-exposed and diseased matched groups. Conclusion This is the largest prospective controlled study of natalizumab exposure in pregnancy, suggesting no increase in risk for major malformations. The benefits of natalizumab continuation must be weighed against high dose steroid treatment these women would need upon relapse following discontinuation. Natalizumab does not appear to increase the baseline risk for major malformations in exposed pregnancies. Further studies are needed for long term effects in these exposed children
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| 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) | 0.002 | 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".