1127 Pregnancy outcomes in alemtuzumab trials and registry design
Bibliographic record
Abstract
Pregnancy outcomes in patients in the alemtuzumab MS clinical development program (CAMMS223 and NCT00050778; CARE-MS I and NCT00530348; CARE-MS II and NCT00548405; CAMMS03409 and NCT00930553) were evaluated. Patients received 2 alemtuzumab courses in core studies (baseline, 5 days; 12 months later, 3 days), and optional, as-needed retreatment during extension per investigator discretion. Pregnant/lactating patients were treatment-ineligible but remained on study for safety follow-up. By December 31, 2015, 200 pregnancies occurred in 137/972 alemtuzumab-treated women, including 182 completed with known outcomes, 11 ongoing, and 7 unknown outcomes. Of completed pregnancies, 123 (68%) were live births without congenital abnormalities or birth defects; 39 (21%) spontaneous abortions, 19 (10%) elective abortions, and 1 (0.5%) stillbirth (previously reported). There was no evidence of teratogenicity, and the spontaneous abortion rate was comparable with other MS and general populations. Women are recommended to use effective contraception during alemtuzumab infusion and for 4 months after. Real-world data are currently collected by the International Lemtrada Pregnancy Exposure Registry, a prospective, noninterventional, observational safety study enrolling patients pregnant during or within 4 months of alemtuzumab exposure in ≥19 countries. It will evaluate pregnancy outcomes, including monitoring infants for adverse events for 1 year. UK pregnancy cases can be reported to: Neuroresearch.nurse@srft.nhs.uk; phone 0161-206-0534. Study Support Sanofi and Bayer HealthCare Pharmaceuticals.
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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 | 0.057 | 0.097 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.009 | 0.002 |
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".