Crohn’s disease is a chronic inflammatory disease of the digestive system. The cause is unknown, and there is no medical cure. The disorder primarily is responsible for ulcerations in the small and large intestines, but can affect the digestive system from the mouth to the anus. Crohn’s disease is closely related to ulcerative colitis, another chronic condition, and both are frequently called IBD (inflammatory bowel disease). It is estimated that there are between 500,000 to 2 million people suffering from the disorders in the United States. Unlike many diseases that affect one sex more than the other, IBD affects the genders equally. IBD generally begins in adolescence or early adulthood, but it can begin earlier or later in life. Individuals who have a close blood relative with Crohn’s disease are more likely to have the disease.
Those affected with Crohn’s disease suffer from abdominal pain and diarrhea. They may also have rectal bleeding, weight loss, fever, and skin problems. Children with Crohn’s disease may suffer from slow growth and development.
Corticosteroids such as prednisone and hydrocortisone have been used in the treatment of Crohn’s disease for many years. Steroids are non-specific treatments, meaning they affect the entire body and not just the disease they are being used for. Cortisteroid treatments have the possibility of side effects, including changes in bone structure and thinning of the skin. These side effects normally do not reverse if the medication is discontinued.
Researchers recently released the results of an international study involving the treatment of Crohn's patients who received a combination of infliximab (Remicade) and azathioprine (Azasan). Patients being treated with both drugs had a higher rate of steroid-free remission than those receiving only one drug.
Researchers divided 508 patients, with moderate to severe Crohn’s disease who had not previously been treated with the drugs involved in the study, into three groups. One group received both infliximab and azathioprine, group two received infliximab and a placebo, and group three received azathioprine and a placebo for 30 weeks, with the option to continue in a blinded study through 50 weeks.
After 50 weeks, 72.2 percent of patients in the drug combination group were in steroid-free remission, as compared to 60.8 percent in the infliximab group, and 54.7 who had taken azathioprine only. The results were released in a Digestive Disease Week news release.
Colonoscopies and a Crohn’s Disease Activity Index were used to measure clinical symptoms. The patients who did not enroll in the study extension to 50 weeks were assumed to have continued symptoms, the remaining patients in steroid-free remission at the end of the study was 46.2 percent of the infliximab plus azathioprine group, 34.9 percent with infliximab therapy, and 24.1 percent with azathioprine treatment.
Patients who developed serious infections were similar in all groups and in the study extension there were no new infections or deaths.
“This study will provide practitioners and their patients with more clinical data on how to use these drugs most appropriately to most effectively treat Crohn’s disease,” study author Dr. William J Sanborn, vice chair of the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minnesota said in a news release. “For the first time, we have longer-term outcome data on the advantages of combination therapy that will help guide our treatment of patients with Crohn’s disease.” In this study patients were started on the drugs earlier than occurs in typical treatment, Sanborn noted.
Infliximab is a monocional antibody, increasingly used to treat several types of gastroenterological disorders. Monocional antibodies are specific antibodies which are identical because they are produced as a clone of a single parent cell to treat a specific disorder.
Dr. Nicholas J. Shaheen, of the University of North Carolina School of Medicine said that the use of monoclonal antibodies is rising for a number of gastroenterological disorders, such as inflammatory bowel disease and new indications for the treatments are continuing to be developed. The safety profile is better understood, making good treatment options for patients with recurrent or chronic gastrointestinal diseases.
Humira, another monoclonal antibody, was approved by the FDA for the treatment of Crohn's disease in 2007. New study results of this drug demonstrate its long-term efficacy in patients with moderately to severely active Crohn's disease.
Crohn’s disease cannot be cured but it may be easier in the future to relieve the symptoms without the side effects associated with older treatments.
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