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Antibody Drug Shows Promise in Some Crohn's Cases ... from the Newswire section - Spring 1998 A new antibody treatment known as cA2 is effective as a short-term treatment of moderate to severe Crohn's disease. Study results published in the New England Journal of Medicine (October 9, 1997) indicate that a single infusion of cA2 reduced disease activity and symptoms, including frequent diarrhea, abdominal pain and fatigue. In some patients, the single treatment was effective in calming symptoms for as long as one year. Other patients required additional infusions at regular intervals to maintain control of their disease. CA2 is a monoclonal antibody that blocks a key inflammatory agent called tumour necrosis factor alpha (TNF-a). TNF, and particularly the overproduction of TNF, is thought to be involved in the development of some diseases associated with inflammation, such as Crohn's and rheumatoid arthritis. CA2 works by binding to the TNF-a on a cell membrane, neutralizing the TNF-a in the blood and destroying TNF-a producing cells. The study, led by Dr. Stephan R. Targan of Cedars-Sinai Medical Center in Los Angeles, involved 108 patients with moderate to severe Crohn's disease that was resistant to treatment. Patients were randomly assigned to receive a placebo or one of three dosage levels of cA2 (5mg, 10mg or 20mg). After four weeks, 81 per cent of patients on the lowest dose, 50 per cent on the medium dose and 64 per cent on the highest dose had improvements in their symptoms compared with 17 per cent who had received the placebo. The study was conducted at sites in North America and Europe, including two patients treated at McMaster University Medical Centre. Researchers indicated that further study is necessary to determine the long-term effectiveness of a single cA2 infusion as well as the effectiveness and safety of repeated infusions. The percentage of patients who experienced side effects - most commonly headache, nausea, upper respiratory tract infection and fatigue - were similar in the placebo and cA2 groups. In a group of 29 patients who received two infusions, two patients had reactions ( chest pains, shortness of breath or nausea) which lead to discontinuation of cA2. The drug, brand named Infliximab, (formerly Avakine) is still in the testing stage. The drug's U.S. manufacturer, Centocor, has filed a Biologics Licence Application with the United States Food and Drug Administration for permission to market the drug. Pending approval the United States, the manufacturer will apply for permission to test and market the drug in Canada this year. CA2 is also showing benefit in the treatment of enterocutaneous fistulae, the abnormal connections between the bowel and the skin. Trial results presented at the American College of Gastroenterology in November and outlined in a company press release indicated that 68 per cent of patients who received three infusions of cA2 experienced closure of at least half their fistulae for one month or more, compared with 26 per cent who received the placebo. Within those results, 55 per cent of patients experienced closure of all their fistulae. The average duration of closure was three months. All patients involved in the test had previously failed standard treatment. The Journal, the CCFC member publication covers the latest in IBD research and management. For more information on how to receive The Journal click here. |
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