Pregnancy Outcomes After Belatacept Exposure in Solid Organ Transplant Recipients: A Scoping Review
Ibrahim Tawhari, Manal Alotaibi, Hany El Hennawy, Fatmah Yamani, Muath Alqahtani, Khalid Asiri, Mohammed TawhariBackground: Pregnancy after solid organ transplantation carries increased maternal and fetal risks, compounded by the teratogenicity, nephrotoxicity, and metabolic effects of available immunosuppressive agents. Belatacept, a calcineurin inhibitor-sparing T-cell costimulation blocker with favorable renal and metabolic profiles, has emerged as an alternative; however, evidence regarding its safety during pregnancy remains scarce. Methods: A scoping review was conducted per PRISMA-ScR recommendations. PubMed, Google Scholar, Web of Science, Scopus, and the Cochrane Library were searched (January 2015–March 2025), supplemented by citation searching, for studies reporting pregnancy outcomes in solid organ transplant recipients receiving belatacept. Methodological quality was assessed using Joanna Briggs Institute critical appraisal tools. Results: Three studies (one case series and two case reports) encompassing 21 pregnancies among 15 recipients were included, predominantly in kidney transplant recipients; several recipients contributed more than one pregnancy, so pregnancy-level outcomes are not statistically independent. Sixteen pregnancies resulted in live birth and five ended in miscarriage, at least four of which occurred in pregnancies with periconception mycophenolate exposure. No congenital malformations were reported among live-born infants, although the number of exposures is far too small to characterize teratogenic risk. Stable allograft function was reported in 14 of 19 pregnancies with available follow-up, with no rejection episodes during belatacept exposure. Maternal complications included preeclampsia (8 of 16 in the case series), gestational diabetes, cytomegalovirus reactivation, and acute kidney injury. Low birth weight (<2500 g) was reported in all live births, predominantly in the context of preterm delivery. Conclusions: The published cases have not identified congenital malformations to date, but the number of documented exposures is far too small to characterize teratogenic risk, and the overall certainty of evidence is very low. Because no comparative studies were available, maternal and neonatal outcomes cannot be assumed equivalent to those of conventional immunosuppression. Belatacept cannot be recommended for routine use during pregnancy; clinical decisions must remain individualized, and preconception counseling and prospective multicenter registries are urgently needed.