A new multi-center study of 854 children with Crohn's disease shows a 5-year cumulative risk of bowel surgery is significantly lower than reported in recent studies. The findings of the study, led by Hasbro Children's Hospital, also indicate that children diagnosed between ages 13 and 16 had an increased risk of bowel surgery, and that a common treatment that begins at diagnosis, immunomodulator therapy, did not alter the risk of surgery.
The study is published in the September 2010 edition of Clinical Gastroenterology and Hepatology.
Crohn's disease (CD) is a condition that involves chronic inflammation of the gastrointestinal tract. While the exact cause is unknown, the condition is often linked to an immune response problem. Treatments include medications that are directed at controlling the inflammation by targeting the immune system. A common treatment is immunomodulator therapy, an agent that balances and improves the immune response of the body in fighting disease-causing agents, Immunomodulators can help reduce the need for corticosteroids while helping to heal fistulas (an abnormal connection between two organs).
Senior author Neal LeLeiko, MD, director of pediatric gastroenterology and nutrition at Hasbro Children's Hospital, led a multi-center observational study of patients under 16 years of age with newly diagnosed inflammatory bowel disease (IBD). All of the patients were enrolled in the Pediatric Inflammatory Bowel Disease Research Group (PIBDRG) Registry from 26 sites across the country. The goal of the study was to examine the incidence of CD-related surgery in pediatric patients and to examine the effect of starting immunomodulator therapy within 30 days of diagnosis.
LeLeiko, who is also a professor at The Warren Alpert Medical School of Brown University says, "The natural history of Crohn's disease often includes bowel surgery, with recent studies reporting surgery risks at one year after diagnosis as high as 34 percent and as high as 47 percent at five years following diagnosis. In this study, we examined the current incidence of bowel surgery." With an increase in the use of immunomodulators as a common therapy at the time of diagnosis in recent years, the researchers also examined its impact.
In terms of the risk of surgery, LeLeiko says, "We have identified older age at diagnosis and greater disease severity to be associated with an increased risk for bowel surgery, along with certain types of disease. The findings, however, indicate that other studies suggest an almost two times greater incidence of surgery than what we found in our study."
The researchers also found that children diagnosed between the ages of 13 and 16 were at greater risk for surgery, however they found no evidence that the early use of immunomodulators is a factor in 5-year surgical outcomes. They also found no link between gender, race or family history of inflammatory bowel disease as factors that would increase the risk of surgery.
LeLeiko concludes, "Our study findings indicate that changing disease behavior over time influences the risk of surgery, and treatments focused on early intervention to alter the natural course of the disease will need to be assessed in studies that ideally involve randomized controlled trials."
Other researchers involved in the study with LeLeiko include the following researchers from institutions affiliated with the PIBDRG: Marc Schaefer, MD, MPH, Jason Machan PhD, David Kawatu, MD of Hasbro Children's Hospital and The Warren Alpert Medical School of Brown University; Christine Langton and Jeffrey Hyams, MD, of Connecticut Children's Medical Center; James Markowitz, MD of Schneider Children's Hospital; Wallace Crandall, MD, of Nationwide Children's Hospital; David Mac, MD of Children's Hospital of Eastern Ontario (Canada); Jonathan Evans, MD of Nemours Clinic; Marian Pfefferkorn, MD of Riley Hospital for Children; Anne Griffiths, MD of Hospital for Sick Children (Canada); Anthony Otley, MD, of IWK Health Centre (Canada); Athos Bousvaros, MD, MPH, of Children's Hospital Boston; Subra Kugathasan, MD of Emory University School of Medicine; Joel Rosh, MD of Goryeb Children's Hospital/Atlantic Health; David Keljo, MD, PhD, of Children's Hospital of Pittsburgh; Ryan Carvalho, MD of Children's Medical Center; Gitit Tomer, MD, of Cincinnati Children's Hospital Medical Center; Petar Mamula, MD, of Children's Hospital of Philadelphia; Marsha Kay, MD, of Children's Hospital, Cleveland Clinic; Benny Kerzner, MD, of Children's National Medical Center; Maria Oliva-Hemker, MD, of Johns Hopkins Medical Institute; Michael Kappelman, MD, of University of North Carolina at Chapel Hill; Shehzad Saeed, MD, of Children's Hospital of Alabama
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