The Next Phase of Inflammatory Bowel Disease Care at Children's Hospital Colorado
Affecting more than 80,000 American children, Inflammatory Bowel Disease (IBD) is a chronic inflammation of the GI tract, including symptoms such as abdominal pain, diarrhea and bloody stool. This taxing illness may be difficult to diagnose and requires long-term treatment. Comprehensive care and effective communication between multiple specialists are important to improve quality of life, maintain normal growth and development and minimize complications.
For this reason, Children's Hospital Colorado has established a multidisciplinary clinical IBD care center that delivers the highest quality care to patients. A comprehensive team of experts addresses all issues a child with IBD might experience and seeks to improve outcomes. This team includes: clinical trials and research, surgery, social work, radiology, pathology, infusions, procedures, pharmacy, therapy, nursing and psychology.
One goal of the IBD center is to foster mutually beneficial relationships with community providers by partnering for care when diagnoses or treatment become complex or overwhelming.
Children's Hospital Colorado follows several IBD patients in Colorado with capacity to expand the current program. There are 20-30 new therapies under development for IBD and Edward Hoffenberg, MD, Pediatric Gastroenterologist at Children's Hospital Colorado, is confident that the IBD center will attract cutting-edge genetic research, advanced therapies and more clinical trials.
Nevertheless, Hoffenberg explains the national need for better care and newer treatments for pediatric patients with IBD.
A significant obstacle in the successful diagnosis and treatment of IBD is variation in care. In a study conducted by Hoffenberg and his colleagues, evidence of underuse, overuse, and misuse of tests and therapies - results of variation in care - in Crohn's patients proved barriers to improved outcomes.
"There is variation in diagnostic and therapeutic interventions in the management of pediatric Crohn disease," the study said. "Gaps exist between recommended and actual care…Knowledge about the types of variation in disease management is the basis for initial efforts to improve care and outcomes."
In the study, examples included variation in diagnostic tests, including a stool test for pathogens, imaging of the small intestine, measurement of Thiopurine methyltransferase (TPMT) before starting treatment with a thiopurine, and testing for tuberculosis before starting treatment with infliximab.
Children's IBD care team addresses this variation in care by promoting teamwork between experts. By coordinating communications and care between primary care provider, nurse, nutritionist, social worker, psychologist and teacher, Children's ensures patients receive the most consistent diagnoses and treatment for IBD.
For more information on IBD at Children's Hospital Colorado, please call (720) 777-6669.
Crohn's Patient Participates in Clinical Trial at Children's
Three years ago, nine-year-old Michelle presented with a 105ºF fever and over the course of the following three months her fever consistently disappeared and reappeared while experiencing persistent fatigue. Her PCP conducted thorough tests during that time, ruling out obvious illness like mononucleosis. When Michelle presented with mouth sores, springtime virus seemed the answer.
When that explanation dried up, Michelle's pediatrician referred her to Children's Hospital Colorado for a CT scan.
Her initial scan revealed inflammation in the bowels which led to a colonoscopy and endoscopy. These procedures showed purple intestines; combined with Michelle's mouth sores, Children's doctors diagnosed her with Crohn's disease, one of two prominent IBD diseases (the other being ulcerative colitis).
"I remember looking at those pictures," said Jennifer, Michelle's mother. "I thought, 'no wonder Michelle has been so sick.'"
"The pictures were astonishing," added Michelle.
Following diagnosis, Michelle immediately began treatment. Common non-surgical treatment for IBD includes aspirin derivatives, immunomodulators, steroids, biologics, diet and nutrition and antibiotics. For the next two years, Michelle tried some of these options, including prednisone, 6-MP and a specialized diet.
These plans gave Michelle some control, but over time treatment did little to diminish her discomfort and the steroids had stunted her growth.
"I was so discouraged and frustrated," said Michelle. "It was the end of the road."
Then, in the summer of 2008, Edward Hoffenberg, MD, pediatric gastroenterologist at Children's Hospital Colorado, approached Michelle and her parents with a promising opportunity: participation in a clinical trial of Humira,® an aggressive tumor necrosis factor (TNF) blocker. Humira is used to treat adult patients with moderate to severe Crohn's
disease, not yet approved by the FDA for the pediatric population.
"We're doing this trial to give children another FDA-approved choice," said Susan Brantz, certified clinical research coordinator at Children's Hospital Colorado. She explained that Humira has proven effective for Crohn's treatment in adults and is more convenient than other treatment options.
Brantz described Humira as a "tough drug," whose subcutaneous injection stings and "is not without possible side effects." According to Humira manufacturer, Abbott Laboratories, these can include increased susceptibility to infection and malignancies, among others.
Sting and side effects aside, Michelle and her parents easily opted to participate in the study.
"After two years of not experiencing life as a 10- or 11-year-old should, it was not a tough decision," Jennifer said.
"We were pretty sure a more powerful drug would work," added Michelle.
As predicted, Michelle's life changed when she received her first Humira shot.
"It seemed to work immediately," said Jennifer. "Humira was amazing."
The first year of Michelle's Humira clinical trial was blinded and Dr. Hoffenberg did not know her exact dosage. Despite that, Michelle went asymptomatic and grew in both height and weight.
"The year has gone beautifully," said Jennifer, who touted Michelle's successes as a teenager, thanks in large part to Humira: straight As, participation in youth group, guitar lessons, and travels to Napa, California and Europe.
"Humira is so easy," said Jennifer. "It's a non-event in our life."
Michelle recently rolled over to the open label portion of the clinical trial, allowing Dr. Hoffenberg to control her prescription, tweaking dosages for even more effective treatment. Dr. Hoffenberg will continue to monitor Michelle's progress, hopeful that the positive effects will last.
"We're thrilled we're able to participate in this trial," said Jennifer. "I feel confident that Michelle will grow and thrive and experience life as a typical 12-year-old."
Michelle's participation in the Humira clinical trial marks one of many changing trends in the GI department at Children's Hospital Colorado. As diagnosis and treatment for IBD become more fine-tuned, opportunities to participate in clinical trials will likely increase.
For Michelle and her parents, the highly specialized, team-oriented care they received at Children's Hospital Colorado has already impacted their lives. Jennifer described round-table discussions in which every member of the GI team shared knowledge about Michelle, considering new drugs and alternative options.
"The team approach is helpful because all clinical researchers know what's going on with Michelle," said Jennifer. "They know her story and who