Interleukin-1 Inhibitors and Pregnancy: How Safe Are They?
This is the first study to investigate the effects of paternal exposure to canukinumab and anakinra on neonatal development.
The use of interleukin-1 (IL-1) inhibitors by men or women ffor the treatment of an inflammatory condition from the period preceding conception to that of breastfeeding, may not significantly affect pregnancy outcomes or infant development, according to an international study published in Rheumatology.1
For this study, retrospective data were gathered from members of the International Society of Systemic Auto-Inflammatory Diseases. A data collection sheet was used to acquire standardized information on the study participants, including maternal age; auto-inflammatory disease diagnosis; obstetric history; pregnancy duration; type of delivery; type, duration, and response to IL-1 inhibitor therapy; mode of infant feeding; and neonatal development.
The investigators identified a total of 43 pregnancies exposed to IL-1 inhibitors in 7 countries, including 14 with canukinumab (8 maternal) and 29 with anakinra (23 maternal). This is the first study to include paternal exposure to canukinumab (n=5) and anakinra (n=6); no negative outcomes were reported. For canukinumab exposure, 8 pregnancies resulted in the delivery of 7 healthy infants of normal gestational age and birthweight. Of the 23 anakinra-exposed pregnancies, the births of 21 healthy infants were reported, as well as 1 baby with unilateral renal agenesis and ectopic neurohypophysis.
In 14 neonates who were breastfed by canukinumab-treated mothers (n=4) or anakinra-treated mothers (n=10) for up to 10 months, no serious infections were reported. No developmental abnormalities were observed over a median follow-up of 18 months. No cases of rilonacept use during pregnancy were included in the study. There were 2 first trimester miscarriages in mothers with active inflammatory disease. No developmental delays were observed over a follow-up period of 10 years (median, 18 months).
“Overall the data show that the use of anakinra and canakinumab appears well tolerated, and efficacious during pregnancy and in males at conception,” concluded the researchers. “Serious questions remain about the increased incidence of renal tract abnormalities seen and this suggests that this should be discussed with all potential parents at preconception counselling,” they added.
Youngstein T, Hoffmann P, Gül A, et al. International multi-centre study of pregnancy outcomes with interleukin-1 inhibitors [published online August 23, 2017]. Rheumatology. doi:10.1093/rheumatology/kex305