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Abstract:
(1) The licensed indications for infliximab, an immunosuppressive agent, cover the treatment of severe or fistulised Crohn's disease after failure of steroids or other immunosuppressants. (2) The clinical file includes two comparative placebo-controlled trials with a total of about 200 patients. It is not clear that all the patients included had severe Crohn's disease, and not all had previously been treated with steroids and/or azathioprine. (3) One trial showed that infliximab monotherapy (optimum dose unknown) in patients with mild to moderate exacerbation despite previous treatment yielded remission in one-third of patients within a month (versus 4% on placebo). Retreatment every eight weeks led to sustained remission after ten months in approximately one-quarter of patients. Some patients who did not respond to the first infliximab injection improved after a second one. (4) A trial involving patients with Crohn's disease and enterocutaneous fistulae showed that infliximab healed the fistulae in one-third of patients, most of whom had not responded to conventional treatment. (5) Data on the adverse effects of infliximab are limited. A risk of potentially severe infection has been established, especially when infliximab is combined with another immunosuppressive drug. The risks of malignancy, delayed hypersensitivity and autoimmune disorders must be better assessed by close pharmacovigilance.