Infliximab (Anti-TNF-alfa) in treating Crohn´s disease

Findings by SBU Alert

This is a translation of version 1, published on January 31, 2001. The latest version of this report is not available in English.

Method and target group

Crohns disease is an inflammatory disease of the gastrointestinal tract. The disease often debuts at young ages, and since there is no curative treatment it is a life long disorder. Common symptoms are diarrhea, abdominal pain, nutritional deficiency, and fever. Usual complications include intestinal constriction and fistula formation. Approximately 13 000 individuals in Sweden have Crohns disease. The number of new cases per year is estimated at 500. Several drugs are currently available to reduce inflammation and ameliorate symptoms. Nevertheless, in approximately 75 percent of the patients, surgical treatment must be used to eliminate inflammation or its effects. The production of TNF-alfa increases in Crohns disease. A new drug, Infliximab (Remicade), was approved in 1999 to treat Crohns disease. The active component in Infliximab is comprised of a monoclonal antibody that targets TNF-alfa. The primary target group for this treatment includes patients with acute exacerbations of Crohns disease and patients with fistula formation who have not responded to conventional treatment.

Patient benefits, complications, and side effects

Two controlled trials have investigated the effects and safety of Infliximab in patients with moderately severe/severe active disease and diseases involving fistula formation. Two smaller non-controlled studies have also been published. Approximately 70 percent of the patients included in the treatment groups demonstrate reduced disease activity compared to about 20 percent in the control groups. Continuing effects were found at two to four months, while the long-term effects have yet to be documented. As a rule, Infliximab treatment has minor to moderate side effects, but it carries a risk for more serious complications, eg, severe infections and hypersensitivity reactions. Potential risks from long-term use have not been established.

Scientific evidence

The findings by Alert show there is moderate* scientific evidence concerning the short-term effects of Infliximab. However, no* scientific evidence is available on the long-term effects and the cost effectiveness of treatment. Infliximab treatment should be confined to the most severely ill patients, and should otherwise be delivered within the framework of controlled studies due to the lack of knowledge about the biological effects of repeated treatment over longer periods. Continued research is needed to answer questions concerning patient benefits, safety, and costs in relation to the available treatment alternatives.

*This assessment by SBU Alert uses a 4-point scale to grade the quality and evidence of the scientific documentation. The grades indicate: (1) good, (2) moderate, (3) poor, or (4) no scientific evidence on the subject.

This summary is based on a report prepared at SBU in collaboration with Kajsa Tunér, MD, Medical Products Agency and has been reviewed by Prof. Åke Danielsson, Norrland University Hospital, Umeå.

The complete report is available in Swedish only.

Alert is a joint effort by the Swedish Council on Technology Assessment in Health Care (SBU), the Medical Products Agency, the National Board of Health and Welfare, and the Federation of Swedish County Councils.

References

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4. Lapidus A. Crohns disease in Stockholm county- Epidemiological panorama and associated gallstone disease. Thesis Stockholm 1998.
5. Lapidus A et al. The costs of Crohns disease in Sweden. Gut 1996;39 (suppl3) abstract.
6. Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ. Infliximab for the treatment of fistulas in patients with Crohns disease. N Engl J Med. 1999 May 6;340(18):1398-405.
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