Ariella Levine Crohn's & Colitis Foundation 646-943-7430 alevine@ccfa.org
Crohn's & Colitis Foundation of America's Clinical Alliance Presents Findings Related to Pregnancy Outcomes in Patients Being Treated for Inflammatory Bowel Disease
Investigators Share Results of National Prospective Pregnancy Registry at June 2009 Digestive Disease Week national conference in Chicago
New York, New York—June 24, 2009—At the June 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 PIANO study (PREGNANCY IN INFLAMMATORY BOWEL DISEASE AND NEONATAL OUTCOMES) was initiated in August 2007 and has enrolled over four hundred patients across the United States. The presentation by the principal investigator, Uma Mahadevan-Velayos, MD of the University of California, San Francisco, reported 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. Mahadevan-Velayos: "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. 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 US 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. Thirty member sites of the CCFA Clinical Alliance identified and followed a prospective cohort of pregnant women with IBD. Data were collected each trimester of pregnancy at delivery and every four months in the first year of the child's life. A history of medications used, the course of IBD activity and pregnancy complications were captured in the data. Pregnancy outcomes, maternal disease course and newborn complications and developmental milestones were recorded for one year from birth.
As of May 2009, the registry enrolled 404 eligible women of whom 237 completed pregnancies. The investigators looked at three groups of patients, one without immunosuppressants or biologics during pregnancy, one exposed to azathioprine/6-mercaptopurine, and one exposed to anti-TNF biologic agents. The incidence of complications was expressed as a percentage and compared to national and regional statistics. The interim analysis revealed no increased risk of adverse events, including congenital anomalies, among patients exposed to the immunomoldulator or biologic drugs.
R. Balfour Sartor, MD, CCFA's Chief Medical Advisor commented: "Large population-based studies have shown that women with IBD have higher rates of preterm birth, low birth weight and complications of pregnancy and delivery. However, there are not enough women on these medications or enough data about them to answer the safety question retrospectively. CCFA is committed to continuing this program, so physicians can learn more about what to expect in pregnancy and pediatric development in patients who rely on medications to control these serious diseases. "
The Alliance has been productive for study and publishing on a host of IBD topics: understanding the natural history of severe UC, variation and time trends in the quality of care, physician opinions on how to improve care and co-occurrence of IBD with other health issues. Currently, there is a group looking at pediatric patients and their natural history by race and ethnicity. Future studies will focus on determining the role of disease activity on complications of pregnancy and the newborn, expand outcome date of the children to 4 years of age to look for developmental delay, and increasing the sample size to have adequate power to detect smaller risks of adverse events.
About Crohn's Disease & Ulcerative Colitis Crohn's disease and ulcerative colitis are painful, medically incurable illnesses that attack the digestive system. Crohn's disease may attack anywhere from the mouth to the anus, while ulcerative colitis inflames only the large intestine (colon). Symptoms may include abdominal pain, persistent diarrhea, rectal bleeding, fever and weight loss. Many patients require hospitalization and surgery. These illnesses can cause severe complications, including colon cancer in patients with long-term disease. Some 1.4 million American adults and children suffer from Crohn's disease or ulcerative colitis, with as many as 150,000 under the age of 18. Most people develop the diseases between the ages of 15 and 35.
About the Crohn's & Colitis Foundation The Crohn's & Colitis Foundation of America's mission is to cure Crohn's disease and ulcerative colitis, and to improve the quality of life of children and adults affected by these diseases. The Foundation ranks third among leading health non-profits in the percentage of expense devoted to research toward a cure, with more than 81 cents of every dollar the Foundation spends goes to mission-critical programs. The Foundation consistently meets the standards of organizations that monitor charities, including the Better Business Bureau's Wise Giving Alliance (give.org) and the American Institute of Philanthropy (charitywatch.org). For more information, contact the Foundation at 800-932-2423 or visit www.ccfa.org.
