Remicade Approved For Children With Crohn's Disease

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Main Category: Crohn's / IBD
Also Included In: Pediatrics / Children's Health;  GastroIntestinal / Gastroenterology
Article Date: 21 May 2006 - 17:00 PDT

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The FDA has approved Remicade (infliximab) for the treatment of Crohn's Disease for children, the first and only approved biologic therapy for children with Crohn's Disease. Remicade is a genetically engineered monoclonal antibody. It reduces inflammation by blocking the action of tumor necrosis factor-alpha. In 1998 this treatment was approved for Crohn's disease treatment for adults.

Dr. Steven Galson FDA, said Remicade is not a cure, but it reduces symptoms significantly so, that maintenance of disease remission in children who have no other safe and effective therapy is possible. He added that the FDA concluded that Remicade's benefits far outweigh the risks for children, after careful evaluation.

A Remicade clinical trial was carried out with 112 children, aged 6-17. They had moderate to severely active Crohn's Disease - they had all responded inadequately to conventional therapies. The results indicated similar favourable results found in previous studies with adults. There were no new safety concerns, when compared with previous adult studies and those listed in the drug's current label.

What is Crohn's disease?

Crohn's Disease is a disorder that causes inflammation of the digestive tract, or GI (gastrointestinal) tract. It can affect any part of the GI tract, but most commonly affects the ileum, the lower part of the small intestine. ('Any part of the GI tract' = From mouth to anus)

For the patient with Crohn's Disease, the swelling goes deep into the lining of the affected area. This can be painful and causes diarrhea.

Crohn's Disease can be hard to diagnose, as the symptoms are similar to those of IBS (Irritable Bowel Syndrome) or Ulcerative Colitis. Unlike Ulcerative Colitis, where inflammation and ulcers only occur in the top layers of the lining of the large intestine, with Crohn's Disease all layers are affected. Also, with Crohn's Disease, healthy sections of the bowel, between the affected areas, can be found.

20% of Crohn's Disease patients have a close relative with some type of inflammatory bowel disease. It affects men and women equally. It can affect all age groups, but is most commonly diagnosed among people aged 20-30. People of Jewish heritage have the highest risk of having Crohn's Disease, while people of African ancestry have the lowest risk.

Another name for Crohn's Disease is Ileitis or Enteritis.

What are the causes of Crohn's Disease?

Nobody is entirely sure because no theory has been proven. It is most likely due to an abnormality in the person's immune system, by mistaking bacteria, foods and some other substances as foreign invaders, and attacking them. This action causes a massive increase in the number of white blood cells that accumulate in the lining of the intestines - leading to chronic inflammation, followed by ulcerations and bowel injury.

We do not know whether this action by the immune system is the cause or the result of the disease.

Scientists say there are three factors which bring about inflammation in the GI tract of people with Crohn's Disease:

-- The patient's genes
-- The patient's immune system
-- The environment

Antigens, or foreign substances, are present in the environment. Perhaps the immune system's reaction to these antigens, or maybe the antigens themselves, cause the inflammation. The immune system produces a protein called tumor Necrosis Factor (TNF) - perhaps the protein causes the inflammation associated with Crohn's disease. Remicade blocks the action of TNF.

Symptoms of Crohn's Disease

Here is a list of some symptoms, their range and severity vary:

-- abdominal pain, often in the lower right area
-- arthritis
-- diarrhea
-- fever
-- rectal bleeding (can be persistent, leading to anemia)
-- skin problems
-- weight loss

Children with Crohn's Disease can experience stunted growth and delayed development.

This web site has useful and concise information on Crohn's Disease
National Digestive Diseases Information Clearinghouse

Written by: Christian Nordqvist
Editor: Medical News Today


Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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