Uma Mahadevan, MD, on Updates From the PIANO Study

Dr Mahadevan spoke at the Advances in Inflammatory Bowel Disease 2020 virtual meeting on the ongoing 13-year  PIANO study designed to assess the outcomes of pregnant women with IBD and their children, up to the age of 4 years.

Uma Mahadevan, MD, is a professor of Medicine at the University of California at San Francisco and codirector of the UCSF Center for Colitis and Crohn’s Disease.

TRANSCRIPT

Hello, my name is Dr. Uma Mahadevan, Professor of Medicine at the University of California San Francisco. At AIBD, I spoke about updates from the PIANO study, Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes.

This 13-year, ongoing, prospective study looked at pregnant women with inflammatory bowel disease, and the outcome of their offspring, out to four years of age. We looked at patients who are unexposed to medication, patients exposed to thiopurines, to biologics, and to both. There were nearly 900 biologic-exposed patients in this study.

The primary endpoint was the rate of congenital anomalies, spontaneous abortions, low birth weight, preterm birth, and infant infections at 1 year. Exposure to medications did not impact these 5 outcomes compared to the unexposed mother and offspring with inflammatory bowel disease.

However, we did see that an increase in disease activity increased risk of spontaneous abortion or miscarriage, and we did see that preterm birth led to an increase in infections in the infant. We also looked at placental transfer in 235 of the 1,490 patients included in this study.

Most of those patients were exposed to TNF, and we did see an increase in a level of infant serum concentration, compared to mother. This was highest in infliximab, with over a 2-fold higher level of drug in the infant compared to the mother.

For ustekinumab and adalimumab, it was closer to 1.4. Certolizumab, a fragment did not cross in levels, were 0 in the infant. Interestingly, vedolizumab, which is an IgG1 antibody, had lower levels in the infant than the mother at a rate of 0.7.

We looked at developmental outcomes in the infants at 1 year, based on exposure to drug, and found no increase in or, I should say, no reduction in developmental milestones, based on drug exposure. Biologic-exposed infants did have some statistically increased improvement in developmental milestones compared to the unexposed group.

Overall, what this study suggests is that women with inflammatory bowel disease should continue their biologics and thiopurines throughout pregnancy to maintain remission, because disease activity can increase spontaneous abortion.

We also know from other studies that disease activity can increase preterm birth. In our study, we showed that preterm birth increased infant infections. The harm was from disease and not from the drug.

While studies are ongoing, including PIANO, following these children out to 18 years of age, based on available data, as well as PIANO lactation data, we can continue these medications throughout pregnancy as well as lactation in the mother with inflammatory bowel disease. Thank you.