Dr Annick Moens

Pregnancy outcomes are similar for women who continue to use vedolizumab to maintain remission from IBD compared to those who use anti-TNF or conventional non-biologic therapies, a European study has shown.

An analysis of pregnancy and neonatal outcomes for 402 women who took IBD therapies during pregnancy found no difference overall in terms of miscarriage, premature birth or congenital anomalies.

The multinational study, carried out in several European countries, assessed pregnancy outcomes in 186 women who took anti-TNF therapy, 89 who took vedolizumab and 184 who used conventional therapy (non biologics).

There was no significant difference in pregnancy complications such as miscarriages, which were 13%, 16% and 10% respectively, even after adjusting for underlying disease activity.

Rates of preterm birth were 9% for anti-TNF therapy, 16% for vedolizumab and 7% for conventional therapy. The slightly higher rate for vedolizumab compared to conventional therapy was not apparent after correcting for underlying disease activity.

Rates of congenital malformations were low and were not significantly different between the groups (2%, 4% and 2% respectively). Likewise, there were no differences between groups for neonatal serious infections up to one year after birth (10%, 7% and 12% respectively).

Study lead author Dr Annick Moens of University Hospitals, Leuven, Belgium, said the study findings provided reassurance about concerns of congenital abnormalities with vedolizumab, which had not been studied in large numbers of patients until now.

She said most women were able to stop taking biologics during the second trimester of pregnancy, but about 25-30% of women in each of the treatment groups continued with therapy throughout pregnancy.

Dr Moens said her hospitals’ general position was to try stop biologics if possible prior to conception, but this depended on the disease activity.

“In this kind of patient, if she was already in deep remission around 4-6 months prior to conception I think it is safe to stop, but if she has active disease or is not in deep remission, [we would] continue the treatment throughout pregnancy,” she said.