The use of biologics in pregnant patients with rheumatic disease.

INTRODUCTION: An increasing number of female patients with autoimmune diseases are treated with biologic drugs. Concerns in regard to safety of biologics during pregnancy arise in patients who have not completed their families. Areas covered: A review of the literature dealing with child outcomes of pregnancies exposed to biologics shows that TNF inhibitors (TNFi) are the best studied in regard to human pregnancy. In studies comparing exposed pregnancies to disease-matched controls no increased risk of spontaneous abortion, low birth weight, prematurity or congenital malformations has been observed. For rituximab, tocilizumab, anakinra, belimumab and ustekinumab no prospective, controlled studies are available, and firm conclusions about their safety during pregnancy cannot be drawn. Expert commentary: TNFi appear fairly safe when given in early pregnancy. For biologics other than TNFi prospective, controlled studies on outcomes after early and late pregnancy exposure are urgently needed. Possible effects of TNFi and all other biologics on children's immune function, infection rate and vaccination responses are either limited or absent and need to be extended. Development of laboratory tests to measure concentrations of biologics routinely in children exposed in utero would facilitate decisions in regard to the time point of vaccination with live vaccines.