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Researchers find anti-TNFs, thiopurines generally safe in pregnancy

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HONOLULU — Anti-TNFs and thiopurines were safe during pregnancy for the treatment of inflammatory bowel disease, but in combination with steroids may cause complications for both patients with and without IBD, according to a plenary presentation at ACG 2015.

“The safety of biologics and immunosuppressive therapy in pregnancy is not well established. … We aimed to investigate the risk associated with the use of steroids, thiopurines and anti-tumor necrosis factor in pregnant women with and without inflammatory bowel disease,” Brindusa Truta, MD, assistant professor of medicine, Johns Hopkins University School of Medicine, said during her presentation.

Brindusa Truta

Truta and colleagues reviewed 1,134,964 deliveries found in the Truven Health Analytics MarketScan database from January 2010 to December 2012 and divided patients into four groups according to exposure during pregnancy: thiopurines; anti-tumor necrosis factor (anti-TNFs) including infliximab, adalimumab, certolizumab; both thiopurines and anti-TNFs; and steroids.

“This is the largest sample population to date and first to analyze steroids used together with immunosuppressive therapy during pregnancy,” Truta said.

Overall, 21,457 women were found to be exposed to the following medications: 522 to anti-TNFs; 317 to thiopurines; 47 to both anti-TNFs and thiopurines; and 20,422 to steroids.

The use of anti-TNFs or thiopurines was not associated with increased risk of intrauterine growth retardation (IUGR), stillbirth or puerperal infection. However, the researchers found that combination therapy with steroids increased the risk for preterm birth (6.8% vs. 19.2%, P = .001).

In addition, the use of steroids was also associated with preterm birth (6.75% vs 11.7%, P < .001), fetal abnormalities (1.8% vs. 2.4%, P < .001), IUGR (2.4% vs. 3.4%, P < .001), and stillbirth (0.5 vs. 0.8%, P < .001).

“These risks were not seen with newer formulations, specifically budesonide,” Truta said.

Of all the deliveries, 6,586 were to women with IBD, of which 1,391 were exposed to the following medications: 368 to anti-TNFs; 223 to thiopurines; 47 to both anti-TNF and thiopurines; and 546 to steroids.

In this IBD population reaction was similar to the general population: steroids were associated with an increased risk for preterm birth (7.8% vs. 13.7%), IUGR (2.5 vs. 5.1%) and stillbirth (0.7% vs. 1.8%, P = .006 for all), but not with budesonide. Findings among the general population and the use of anti-TNFs or thiopurines were also similar.

Truta concluded: “The use of anti-TNFs and thiopurines in pregnancy is generally safe; however, combination therapy and the chronic use of conventional steroids increases the risk for pregnancy complications and severe acute respiratory infections in the babies’ first year of life.” – by Melinda Stevens

Reference: 

Truta B, et al. Abstract 52. Presented at: ACG; Oct. 16-21, 2015; Honolulu.

Disclosures: The researchers report no relevant financial disclosures.