Peer-reviewed article
A case series of rheumatoid arthritis patients exposed to an etanercept biosimilar during pregnancy: Evidence from an increasingly accepted treatment option.
Kitada A, Takai C, Higuchi A, Miyagawa E, Ozawa N et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a medical study about treating pregnant women with rheumatoid arthritis using an etanercept biosimilar drug. It reports outcomes from 11 pregnancies at a Japanese hospital, finding that all resulted in live births with generally healthy neonates. The study concludes the drug appears safe to use during pregnancy.
Key points
- All 11 pregnancies resulted in live births
- Median birth weight was 2929 g with one preterm birth
- No neonatal intensive care unit admissions were reported
- All neonates had Apgar scores of 9 or higher at 5 minutes
- The drug was discontinued before delivery in 4 cases to permit infant vaccination
Limitations
This is a small case series of 11 pregnancies from a single centre with no comparison group, so it cannot establish causation or compare safety against alternative treatments. The study focuses on maternal and immediate neonatal medical outcomes rather than child well-being or development.
Abstract
Objective To assess pregnancy and neonatal outcomes in women with rheumatoid arthritis treated with an etanercept biosimilar, and to provide real-world safety evidence. Methods This retrospective, single-centre study included 11 pregnant women with rheumatoid arthritis who received an etanercept biosimilar at the National Center for Child Health and Development (Tokyo) between October 2018 and March 2022. The clinical characteristics, disease activity, medications, delivery outcomes, and neonatal health were reviewed. Results All 11 pregnancies were live births. The median maternal age was 34 years, the gestational age at delivery was 39.7 weeks, and the birth weight was 2929 g. One preterm birth (9.1%) and two caesarean deliveries (18.2%) occurred. No cases of low birth weight or neonatal intensive care unit admission were reported. One case of patent foramen ovale was noted. All neonates had 5-minute Apgar scores of ≥9. The etanercept biosimilar was discontinued before delivery in four cases to allow for infant vaccination. Conclusion Use of the etanercept biosimilar during pregnancy was associated with favourable outcomes, supporting its safety and utility in managing rheumatoid arthritis during pregnancy.