PhD defence N. (Nafise) Ghalandari

Summary:

When planning to become pregnant, women with immune-mediated autoimmune diseases (IMIDs) face many challenges. Due to lack of data, the use of many effective treatments (such as the majority of biologics) during pregnancy is not recommended. Only a few of the treatment options are authorized to be used during pregnancy, which may not be enough to control the disease. Before market authorization, no data on medicinal product use during pregnancy can be assembled as its unethical to expose unborn children to unauthorized medications. After a drug is marketed gathering reliable evidence in respect to safety during pregnancy is failed in many cases. Women suffering from IMIDs have a dilemma between stopping the biologics with risking flares and its consequences, versus continuing the biologics without often knowing the exact consequences for the foetus. The aim of this dissertation is to fill in the knowledge gaps on the use of biologics during pregnancy in women suffering from IMIDs. To address this aim we used different information sources: for retrospective studies data was assembled from European Medicines Agency’s (EMA) EudraVigilance database; for prospective studies, patients were included from the Preconceptional Counselling in Active Rheumatoid Arthritis (PreCARA) cohort at Erasmus Medical Center in Rotterdam, the Netherlands.