June 11, 2019
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‘Reassuring’ data on late Remicade discontinuation in pregnancy

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Brindusa Truta
Brindusa Truta

SAN DIEGO — There appeared to be no difference in child outcomes whether a pregnant mother with inflammatory bowel disease discontinued Remicade therapy early or late in her pregnancy, according to research presented at Digestive Disease Week.

Brindusa Truta, MD, of Johns Hopkins University, said that patients might elect to discontinue biologics early in pregnancy because not much data are available on intra-uterine exposure. However, getting off of biologic therapy could cause the mother’s IBD to worsen, which presents its own problems for the baby.

“Patients may discontinue the biologics early in pregnancy because there are concerns about the potential toxicity of the drug,” Truta said in her presentation. “The discontinuation of therapy can trigger a disease flare, but we have learned that active disease may lead to preterm birth or low birthweight babies.”

Researchers compared the pregnancy outcomes in mothers with IBD who discontinued Remicade (infliximab, Janssen) early — defined as more than 90 days before delivery —vs. late — defined as less than 90 days before delivery — during gestation. They analyzed data on all deliveries recorded in the Truven Health Analytics MarketScan database from 2011 to 2015 and found 451 deliveries that included mothers with IBD treated with infliximab.

Overall, 377 patients ended their biologic therapy late in their pregnancy compared with 74 who ended it early. Investigators then explored outcomes related to both the child, such as acute respiratory infection and developmental delay, and the mother, like premature baby and c-section.

Truta and colleagues found that children of mothers who discontinued infliximab therapy late in pregnancy did not show a significant difference in outcomes compared with children born to mothers who ended biologic therapy earlier. The mothers themselves also did not experience any differences.

Researchers found that mothers who discontinued infliximab early were more likely to use steroids after discontinuation compared with patients who ended biologic therapy later in gestation (17.6% vs. 3.2%; P < .001). Both groups had similar thiopurine use both before and after discontinuation.

Truta said that their findings show there was no difference in pregnancy outcomes if mothers discontinued infliximab early vs. late in pregnancy.

“However, infliximab discontinuation is more likely to precipitate flares as suggested by the usage of steroids,” she said. “This data is reassuring for the physicians and their patients concerned about the toxic effects of infliximab on the fetus.” – by Alex Young

Reference:

Truta B, et al. Abstract 43. Presented at: Digestive Disease Week 2019. May 18-21; San Diego, California.

Disclosures: Truta reports no relevant financial disclosures. Please see the meeting disclosure index for all other authors’ relevant financial disclosures.