STUDY DESIGN AND RECRUITMENT INTO THE BELIMUMAB MOTHERTOBABY PREGNANCY EXPOSURE STUDY: AN OTIS AUTOIMMUNE DISEASES IN PREGNANCY PROJECT
Bibliographic record
Abstract
PV187 / #637 Poster Topic: AS21 - Pregnancy and Reproductive Health Background/Purpose Belimumab is a human monoclonal antibody that inhibits B lymphocyte stimulator protein (BLyS). Among other countries, belimumab is approved in the United States (US) and Canada for systemic lupus erythematosus (SLE) and lupus nephritis in people 5 years of age and older. Data on belimumab exposure during pregnancy is limited. The OTIS Pregnancy Exposure Registry is a US based study designed to monitor pregnancy and infant outcomes among people in the US and Canada. Pregnancy registries are an important component of post-marketing surveillance to assess the safety of new medications. Presented is an overview of the study design and recruitment into this pregnancy study. The study will monitor pregnancies for the occurrence of major structural birth defects, spontaneous abortion, elective termination, stillbirth, preterm delivery, pattern of 3 or more minor structural defects, small-for-gestational age, postnatal growth and developmental performance at approximately 1 year of age, and serious infections in the first year of life in pregnancies exposed to belimumab, relative toa disease comparison (DC) group of pregnant participants with SLE. Methods This research study is a North American, prospective cohort study comparing pregnancy outcomes in participants exposed to belimumab to a DC group without belimumab exposure. Women with SLE who have been exposed to belimumab during pregnancy, or within 3 months of the last menstrual period, and who have not had any abnormal prenatal screening or diagnostic test indicating a major structural defect as eligible for enrollment. Those who do not meet the eligibility criteria are eligible for a “case series” cohort. These data may be used to illuminate any findings in the cohort study. Recruitment began in November 2022 and will continue through 2027, with a goal of 200 participants in each cohort. The study captures data on exposures, outcomes and covariates through maternal interviews and maternal and pediatric medical records, a dysmorphology exam, and developmental screening of the child using the Ages and Stages online questionnaire. Disease severity is captured with information from medical records. Results Between November 10, 2022 and November 1, 2024, 30 participants were enrolled (17 belimumab-exposed, 9 DC, and 3 in the belimumab-exposed case series). Conclusions With the help of rheumatologists and other providers specializing in the care of patients with SLE, this study will collect information that will help healthcare professionals and their patients make informed treatment decisions during pregnancy.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".