Biologics can be safe for pregnancy

4 minute read


Despite concerns generated by media, there’s little evidence of adverse outcomes Experts are looking to reassure women with inflammatory arthritis that, in most cases, they can safely continue their medications during pregnancy and while breastfeeding. Women and rheumatologists have been concerned about the outcomes after intrauterine exposure and vaccinations in infants, which was, in part, […]


Despite concerns generated by media, there’s little evidence of adverse outcomes

Experts are looking to reassure women with inflammatory arthritis that, in most cases, they can safely continue their medications during pregnancy and while breastfeeding.

Women and rheumatologists have been concerned about the outcomes after intrauterine exposure and vaccinations in infants, which was, in part, sparked by a report of the death of a child following the BCG vaccine.

The mother had been using infliximab for her Crohn’s disease and when the child was vaccinated with at three months of age, it was thought that a disseminated BCG infection might have developed as a result of the immunosuppressant effects of the biologic.

“Obviously that caused a lot of stress, and since then people have been terrified about what to do with the vaccines and the children,” Dr Stephanie Bond, a rheumatology registrar at Townsville hospital said.

Dr Bond and a team of investigators consequently conducted a study into attitudes and practices of Australian women who took biologics during pregnancy, particularly with regard to breastfeeding and infant vaccination.

Women with inflammatory arthritis were asked to complete a retrospective questionnaire that sought to document current medications, previous medications and whether they had stopped taking any of their medications through the pregnancy.They also were asked about their infants’ vaccination schedule.

“The current recommendations are that all vaccines that are live vaccines, which in Australia is rotavirus, are withheld until six months of age,” Dr  Bond said.  But clinicians might also need to withhold the BCG vaccine. If the child was travelling to areas at risk of TB , being unvaccinated will carry its own risks.

Of the 35 babies born to 28 women participating in the study, all received some vaccinations in infancy.  However, 16 infants were exposed to biologic or targeted synthetic DMARDs after the British guideline cut off, and among these, 13 were not vaccinated according to the guidelines.

At the moment, these guidelines recommend ceasing golimumab after 12 weeks, infliximab after 16 weeks and adalimumab and etanercept after 28 weeks. Because of low placental transmissions, the guidelines support certolizumab use throughout pregnancy.  However, if mothers do continue the medication beyond the cutoffs, the guidelines recommend delaying live vaccines for infants until six months of age. 

“We found in our study some people were withholding the first vaccine but not the second, some people were withholding other vaccines that didn’t need to be withheld, and there was a bit of a mishmash of what people were doing,” Dr Bond said.

One mother chose not to give her child any live or inactive vaccinations until the age of two. On the other hand, eight did not have any vaccines delayed. Regardless, serious neonatal infections were not found.

When it came to breastfeeding, the majority of women breastfed their infants and 10 of these were women who had continued their biologic during the third trimester and while breastfeeding.

Nevertheless, the researchers found no adverse outcomes such as infection or allergy among these infants. Two of the mothers were advised to avoid, and one to cease, breastfeeding in order to recommence their biologic, although current recommendations say that TNFis are safe during lactation. “It is thought that only a very small amount is getting into breast milk from the mother, and because they tend to be large proteins, not much is absorbed into the baby’s gastrointestinal tract,” Dr Bond said, meaning they were unlikely to be immunocompromised.

But despite concerns generated by media reports, the researchers found, over the 10-year duration of the study, the situation did seem to be improving with more women adhering to international and local recommendations as time progressed, she added.

The study authors conceded the research was limited by the small number of participants and the relatively short follow-up time.  But the study is ongoing and clinicians are encouraged to sign their pregnant arthritis patients to the study in order to develop a stronger database.

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