New Therapy Studied for Ulcerative Colitis

Ulcerative colitis may be effectively treated with new formulation of anti inflammatory steroid

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Budesonide reduces swelling in the digestive tract of those with inflammatory bowel disease (IBD). A new extended-release version seems to be effective and safe for treating ulcerative colitis, a type of IBD.

Ulcerative colitis causes long-lasting inflammation and sores in the inner lining of the large intestine, or colon. The US Food and Drug Administration (FDA) approved the synthetic steroid budesonide in a continuous-release tablet (budesonide-MMX) to fight mild and moderate ulcerative colitis in January 2013.

A new study from Spain confirmed that this extended-release system of budesonide may work well in treating ulcerative colitis and that it may have fewer side effects compared to other steroids used for long-term therapy.

This investigation noted, however, that mesalamine, a long-established ulcerative colitis medication, may still be more effective than budesonide.

"Work with your doctor to find the right ulcerative colitis medication for you."

Pilar Nos, MD, with the Gastroenterology Unit in the Department of Digestive Disease at La Fe University and Polytechnic Hospital in Valencia, Spain, and colleagues summarized the latest research from more than 40 sources related to the long-term safety and effectiveness of budesonide in treating ulcerative colitis.

With ulcerative colitis, the lining of the large intestine becomes inflamed and develops sores (ulcers), which lead to bleeding and diarrhea. Although there is no known cure for ulcerative colitis that doesn't involve surgically removing the entire colon, steroids (specifically corticosteroids) can help suppress inflammation and allow tissue to heal, which in turn reduces symptoms such as bleeding, abdominal pain and diarrhea.

Steroids, however, may cause multiple adverse effects such as weight gain, mood swings and depression. Long-term use of these steroids (beyond three months) may lead to further complications such as muscle and bone weakness, diabetes, high blood pressure and glaucoma.

Taken orally once a day, a new version of the corticosteroid budesonide, called budesonide-MMX (brand name Uceris), targets medication delivery to the colon and releases the medication gradually. These factors may help reduce negative side effects with budesonide compared to conventional corticosteroids, according to the authors' review of current research.

In discussing side effects of budesonide, Dr. Nos and colleagues referred to five trials conducted with more than 200 Crohn's disease patients over a year. Crohn's disease is another type of inflammatory bowel disease. In comparing those who took 6 mg of budesonide a day to those who took a placebo, the researchers found that at 52 weeks, "clinically important or serious adverse effects associated with systemic corticosteroids were very infrequent and similar between groups."

The investigators noted that data is limited about budesonide's ability to induce remission of ulcerative colitis. Remission is a decrease or disappearance of signs and symptoms of the disease.

One of the biggest studies referred to by Dr. Nos and team compared the effectiveness of budesonide and mesalamine. Mesalamine (also called mesalazine) is another treatment option for ulcerative colitis. Approved by the FDA in 1987, mesalamine (brand names Pentasa, Rowasa, Asacol, Lialda, Canasa) is not a steroid but an aminosalicyclic acid. It is chemically related to aspirin.

Led by William J. Sandborn, MD, chief of the Division of Gastroenterology at UC San Diego, and published in the journal Gastroenterology in November 2012, the investigation followed 509 patients who were given either budesonide-MMX, mesalamine or a placebo (fake medication) daily. After eight weeks, the rate of clinical improvement was 33.3 percent for those receiving 9 mg of budesonide, 30.6 percent for those receiving 6 mg of budesonide and 33.9 percent for those taking 2.4 g of mesalamine. For those on the placebo, improvement was measured as 24.8 percent.

“Budesonide may be a viable therapeutic option in patients with active mild to mod­erate [ulcerative colitis],” wrote the authors. “Current studies have failed to demonstrate higher efficacy of budesonide versus mesalazine for the induction of remission in active [ulcerative colitis] patients. Mesalazine is superior to budesonide for the treatment of active [ulcerative colitis].”

This research was published in February in Clinical and Experimental Gastroenterology, a peer-reviewed medical journal covering research in gastroenterology.

Review Date: 
February 20, 2014
Last Updated:
February 21, 2014