Crohn's and colitis drug effective in trials
Two studies published this week in the New England Journal of Medicine found that the drug vedolizumab may be an effective treatment for patients with inflammatory bowel conditions, for whom other treatments haven’t worked.
Crohn's disease and ulcerative colitis are the two most common types of inflammatory bowel disease, and can become so severe that they lead to bowel obstruction or colon cancer. Some patients may even have to have part of their bowel removed. Symptoms can range from diarrhea and bleeding, to fatigue, weight loss and anemia.
The two trials are part of the four-part study GEMINI program that is investigating vedolizumab in 2,700 patients in 40 countries, and is the largest phase 3 trial to evaluate both Crohn's disease and ulcerative colitis together. GEMINI I evaluated vedolizumab in patients with ulcerative colitis and GEMINI II tested the drug in patients with Crohn's disease. To participate in the trials, patients needed to have failed to be helped by at least one conventional treatment.
The researchers believe that vedolizumab may be a better treatment option for Crohn's and ulcerative colitis patients because it focuses specifically on bacteria in the gut. Generally, people fighting colitis and Crohn's have to take a broad spectrum anti-inflammatory medications that not only affect inflammation in the gut, but also in the lungs, skin and brain, which can lead to side effects such as pneumonia, skin infections and blood infections.
The study results for GEMINI I show that in patients with ulcerative colitis, the drug met its primary goals of improved clinical response and reduction in rectal bleeding at six weeks and clinical remission at 52 weeks. For the Crohn's patients part of GEMINI II, the results reflected that vedolizumab had a statistically significant improvement in the primary goal of clinical remission at six and 52 weeks compared with placebo.A Japanese pharmaceutical company has recently applied to the US Food and Drug Administration (FDA) for vedolizumab to be licensed for the treatment of adults with moderately to severely active Crohn's disease and ulcerative colitis.