Effects of an Anti‐TNF‐α Monoclonal Antibody, Administered Throughout Pregnancy and Lactation, on the Development of the Macaque Immune System

Abstract

PROBLEM: The use of anti-TNF-alpha therapies during pregnancy and lactation on the development of the neonatal immune system has not been fully established. The purpose of this study was to evaluate whether treatment of macaques with an anti-TNF-alpha monoclonal antibody (golimumab) during pregnancy and lactation would result in defects in the developing immune system. METHOD OF STUDY: Pregnant macaques were treated with golimumab during pregnancy and lactation. Immune system development was evaluated by histopathology, lymphocyte subset analysis and functional challenging of the infant immune system (humoral immune response to KLH and TTX, and DTH skin reaction). RESULTS: In utero and postnatal exposure to golimumab had no effect on T and B cell populations in blood and lymphoid tissues and did not impair the ability of the infants to mount an immune response to antigen challenge. CONCLUSION: Treatment of pregnant macaques with golimumab throughout pregnancy and lactation did not affect the development and maturation of the immune system in the offspring.