NEW YORK—At the 2009 Digestive Disease Week conference in Chicago, preliminary data were presented to an international gathering of gastroenterologists, on the subject of pregnancy in patients with Crohn's disease and ulcerative colitis, collectively known as inflammatory bowel disease (IBD). The study, Pregnancy in Inflammatory Bowel Disease And Neonatal Outcomes, (the PIANO study) was initiated in August 2007 and has enrolled more than 400 patients across the United States.
The study included information on the relative safety of prevalent treatments for inflammatory bowel diseases in the context of pregnancy and neonatal outcomes.
The rationale behind the registry, a top priority for Crohn's & Colitis Foundation of America and its Clinical Alliance—a nationwide network of medical centers committed to improving care for IBD patients through effective clinical research—is explained by Dr. Uma Mahadevan-Velayos of the University of California, San Francisco.
"When we diagnose Crohn's disease or ulcerative colitis, there are always three primary patient questions: effect on lifespan, the need for medications, and ability to safely have children,” Mahadevan-Velayos said. “The CCFA Pregnancy Registry has been designed to enable us to answer the third question. At the current time, our answers are based on limited data and we have to tell anxious mothers that it is "probably" safe but we don't have enough information. "Because the average age of diagnosis with IBD—20 to 30—is during the prime child-bearing years, the study has relevance to most patients.”
The objective of the registry is to determine whether there is a higher rate of adverse events in a prospective national sample of women from the United States with IBD who are being treated with azathioprine/6MP or anti-TNF biologic drugs (infliximab, adalimumab, certolizumab). The safety of these immunomodulator and biologic therapies during pregnancy has not been previously studied prospectively with adequate sample size to determine risk for adverse events. Adverse events considered included: congenital malformations, spontaneous abortion, preterm birth, and low birth weight infants.