STUDY DESIGN AND RECRUITMENT INTO THE BELIMUMAB MOTHERTOBABY PREGNANCY EXPOSURE STUDY: AN OTIS AUTOIMMUNE DISEASES IN PREGNANCY PROJECT
Notice bibliographique
Résumé
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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,001 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».