In recent years, the medical treatment of inflammatory bowel disease (IBD) has gotten more attention from pharmaceutical companies and researchers. Colazal and Entocort are two drugs recently developed for treating IBD. The future for people with IBD is brighter than ever, as more drugs are in the pipeline to treat these debilitating diseases and their associated complications.
Natalizumab
This drug is already approved for use in certain forms of multiple sclerosis through a restricted distribution program. Elan Corporation and Biogen Idec, the developers of natalizumab (Tysabri), have filed with the FDA to have this drug approved for use in treating Crohn’s disease. In one study, 61 percent of patients taking natalizumab showed a response to the drug, while only 28 percent of those taking a placebo showed a response.
Certolizumab
Developed by UCB, certolizumab (Cimzia, CDP870) was submitted to the FDA for approval for use in treating patients with Crohn’s disease. In December 2006, the FDA requested clarification of data and more information on the drug.
Research has shown that certolizumab was effective in decreasing the symptoms of Crohn's disease. Of the patients who received certolizumab in one study, 47.9 percent were in clinical remission after 26 weeks. Certolizumab is given by injection.
Two clinical trials, published in the New England Journal of Medicine, examined certolizumab for the treatment of Crohn's disease. The first (PRECISE 1) showed that the drug can improve symptoms in the short and intermediate-term but cannot provide significant benefits, such as remission. The second trial (PRECISE 2) showed that maintenance therapy prevents relapse in those patients who have a good response to initial treatment.
Rifaximin
Rifaximin (Xifaxan) is currently being studied for use in treating severe Crohn’s disease. This drug, manufactured by Salix Pharmaceuticals, is an antibiotic currently approved for use in traveler’s diarrhea. Rifaximin is not absorbed into the bloodstream like other antibiotics, but instead affects the digestive tract directly. The theory is that intestinal bacteria may have a connection to the inflammation in Crohn’s disease, and an antibiotic may be effective if it kills these bacteria.
In a 16-week study of rifaximin, 78 percent of the patients with Crohn’s disease experienced an improvement in their disease, and 59 percent went into remission.
This drug is also being studied for use in treating pouchitis, a complication that can occur after j-pouch surgery. In one study, 11 patients for whom other therapies had failed received either 400 mg of rifaximin twice a day or 200 mg three times a day -- both groups showed improvement.
Teduglutide
This new compound is being studied for use in both IBD and short bowel syndrome (SBS). SBS is a condition that causes diarrhea, cramping, bloating, and heartburn that occurs in people who have had half (or more) of their small intestine removed. The most common cause of SBS is repeated resection surgeries used to treat Crohn’s disease.
Side effects of teduglutide appear to be minimal, as the effects occur mainly in the intestinal tract. People with SBS who participated in a trial of teduglutide showed both increased nutrient intake and body weight. Commonly reported adverse effects included abdominal pain, headache, stoma changes, and swelling.
NPS Pharmaceuticals, the developer of teduglutide, expects to apply for FDA approval in 2008. Teduglutide has been granted orphan drug status in both the United States and Europe for its use in SBS. NPS is currently determining the appropriate dose levels of teduglutide in order to start testing the drug for use in Crohn’s disease.
Colal-Pred
Colal-Pred (ATL-2502) is an old drug (prednisolone metasulphobenzoate, a steroid) with a new delivery system that releases the medication only in the colon. Releasing the drug directly into the colon reduces the potential for significant side effects often experienced with steroid drugs. Colal-Pred is being studied for use in ulcerative colitis.
This drug is under development by Alizyme, which is now recruiting patients with active ulcerative colitis for a study in Europe. In a preliminary study, ulcerative colitis patients tolerated the drug well, showed improvement rates similar to those demonstrated with prednisone, and did not experience steroid-related side effects.
