Infliximab (Remicade) cuts need for surgery in ulcerative colitis

Infliximab (Remicade) cuts the need for surgery in ulcerative colitis patients by almost half, a new study found.

Ulcerative colitis patients often need surgery to remove the colon as the diseases causes chronic inflammation of the colon.

About 25 to 40 percent of ulcerative colitis patients must eventually have their colons removed because of massive bleeding, severe illness, rupture of the colon, or risk of cancer. Surgery to remove the colon and rectum, known as proctocolectomy, is followed ileostomy or ileonal anastamosis.

In ileostomy, small opening is created in the abdomen, called a stoma, and attaches the end of the small intestine, called the ileum, to it. Waste will travel through the small intestine and exit the body through the stoma.

Ileoanal anastomosis, or pull-through operation, which allows the patient to have normal bowel movements because it preserves part of the anus. In this operation, the surgeon removes the colon and the inside of the rectum, leaving the outer muscles of the rectum. The surgeon then attaches the ileum to the inside of the rectum and the anus, creating a pouch. Waste is stored in the pouch and passes through the anus in the usual manner.

Infliximab study included 728 patients. the patients eceived either an inactive placebo or infliximab for 46 weeks.

After one year of follow-up, the researchers found that “treatment with infliximab reduced the need for colectomy by 41 percent compared to patients treated with placebo,” lead author and Mayo Clinic gastroenterologist Dr. William Sandborn, said in a Mayo Clinic news release.

“One of the most feared outcomes for ulcerative colitis patients is surgical removal of the colon. Our research hopes to provide other treatment solutions for patients beyond surgery,” Sandborn said in the study appeared in the October issue of the journal Gastroenterology.

Infliximab or Remicade is a chimeric monoclonal antibody that reduces production of TNF-alpha (tumour necrosis factor alpha) which has been shown to be part of the autoimmune component in Crohn’s Disease and rehoumatoid arthritis. It is made up of part-human part mouse protein, and is administered by infusion (usually on an outpatient basis).

Remicade won its initial approval by the FDA for the treatment of Crohn’s disease in August 1998.

Infliximab is an expensive medication, costing about US$1650 for a 100 mg dose in US.

Infliximab or Remicade is marketed by Centocor Ortho Biotech Inc.

What is ulcerative colitis?

Ulcerative colitis is an inflammatory bowel disease (IBD), the general name for diseases that cause inflammation in the small intestine and colon. Ulcerative colitis causes ulcers in the lining of the rectum and colon. Ulcers then bleed and produce pus. Inflammation in the colon also causes the colon to empty frequently, causing diarrhea.

When the inflammation occurs in the rectum and lower part of the colon it is called ulcerative proctitis. If the entire colon is affected it is called pancolitis. If only the left side of the colon is affected it is called limited or distal colitis.

Ulcerative colitis can occur in people of any age, but it usually starts between the ages of 15 and 30, and less frequently between 50 and 70 years of age.

Ulcerative colitis affects men and women equally and appears to run in families, with reports of up to 20 percent of people with ulcerative colitis having a family member or relative with ulcerative colitis or Crohn’s disease. A higher incidence of ulcerative colitis is seen in Whites and people of Jewish descent.

The most common symptoms of ulcerative colitis are abdominal pain and bloody diarrhea. Patients also may experience anemia,fatigue, weight loss,loss of appetite, rectal bleeding etc.

People with ulcerative colitis have abnormalities of the immune system. The body’s immune system is believed to react abnormally to the bacteria in the digestive tract.

A colonoscopy or sigmoidoscopy are the most accurate methods for making a diagnosis of ulcerative colitis and ruling-out other possible conditions, such as Crohn’s disease, diverticular disease, or cancer.

Several types of drugs are available to treat ulcerative colitis.

Aminosalicylates, drugs that contain 5-aminosalicyclic acid (5-ASA), help control inflammation. Sulfasalazine is a combination of sulfapyridine and 5-ASA. The sulfapyridine component carries the anti-inflammatory 5-ASA to the intestine. However, sulfapyridine may lead to side effects such as nausea, vomiting, heartburn, diarrhea, and headache.

Other 5-ASA agents, such as olsalazine, mesalamine, and balsalazide, have a different carrier, fewer side effects, and may be used by people who cannot take sulfasalazine. 5-ASAs are given orally, through an enema, or in a suppository.

Corticosteroids such as prednisone, methylprednisone, and hydrocortisone also reduce inflammation.

Immunomodulators such as azathioprine and 6-mercapto-purine (6-MP) reduce inflammation by affecting the immune system. These drugs are used for patients who have not responded to 5-ASAs or corticosteroids or who are dependent on corticosteroids. Cyclosporine A may be used with 6-MP or azathioprine to treat active, severe ulcerative colitis in people who do not respond to intravenous corticosteroids.