(1) The licensed indications for infliximab, an immunosuppressive agent, cover the treatment of severe or fistulised @entity30 after failure of @entity230 or other immunosuppressants. (2) The clinical file includes two comparative placebo-controlled trials with a total of about 200 @entity1 . It is not clear that all the @entity1 included had severe @entity30 , and not all had previously been treated with @entity230 and/or @entity500 . (3) One trial showed that infliximab monotherapy (optimum dose unknown) in @entity1 with mild to moderate exacerbation despite previous treatment yielded remission in one-third of @entity1 within a month (versus 4% on placebo). Retreatment every eight weeks led to sustained remission after ten months in approximately one-quarter of @entity1 . Some @entity1 who did not respond to the first infliximab injection improved after a second one. (4) A trial involving @entity1 with @entity30 and enterocutaneous fistulae showed that infliximab healed the fistulae in one-third of @entity1 , most of whom had not responded to conventional treatment. (5) Data on the adverse effects of infliximab are limited. A risk of potentially severe @entity281 has been established, especially when infliximab is combined with another immunosuppressive drug. The risks of @entity5 , delayed @entity56 and @entity792 must be better assessed by close pharmacovigilance.

Infliximab: new preparation. A last resort for XXXX .

@entity1 :: ('9606', 'Species') :: ['patients'] @entity500 :: ('MESH:D001379', 'Chemical') :: ['azathioprine'] @entity5 :: ('MESH:D009369', 'Disease') :: ['malignancy'] @entity281 :: ('MESH:D007239', 'Disease') :: ['infection'] @entity56 :: ('MESH:D004342', 'Disease') :: ['hypersensitivity'] @entity792 :: ('MESH:D001327', 'Disease') :: ['autoimmune disorders'] @entity230 :: ('MESH:D013256', 'Chemical') :: ['steroids'] @entity30 :: ('MESH:D003424', 'Disease') :: ["Crohn's disease"]
@entity30 :: (MESH:D003424,Disease) :: ['Crohn's disease']
