Safety aspects of infliximab in inflammatory bowel disease patients - A retrospective cohort study in 100 patients of a German University Hospital

Background: Infliximab, a chimeric anti-tumour necrosis factor
monoclonal antibody with potent anti-inflammatory effects,
represents an effective treatment option in patients with severe
inflammatory bowel disease (IBD). Serious side-effects of such an
immunomodulating therapy are speculated and therefore we reviewed
our clinical experience in a retrospective safety study looking
upon a single cohort of 100 IBD patients from a large German
University Hospital. Methods: 100 patients with severe Crohn's
disease (n = 92), ulcerative colitis (n = 7) or indeterminate
colitis (n = 1) treated with infliximab (5 mg/kg) from January 2000
to December 2003 were retrospectively analysed for acute and
subacute adverse events by chart review. Results: Overall,
infliximab therapy was generally well tolerated. No fatal
complications, malignancies, autoimmune diseases, neurologic or
cardiovascular complications were observed in the cohort during the
study period. Overall, adverse events were observed in 10 patients:
2 patients showed an acute infusion reaction, 1 patient a serum
sickness-like reaction, in 4 patients a bacterial or viral
infection occurred, in 1 patient pancytopenia and 2 patients
developed surgical complications. Only 6 patients with adverse
events required admission to hospital. A case of tuberculosis after
infliximab was not found. The lack of adverse side-effects was
associated with young median age and infrequent comorbidities of
the cohort. Conclusion: Regarding its strong immunomodulating
capacity, infliximab appears to be an efficient and relatively safe
therapeutic option for patients with severe IBD. However, the use
of infliximab requires careful screening and close patient
monitoring to identify patients at risk and the infrequent, but
sometimes serious complications of infliximab. Copyright (C) 2004
S. Karger AG, Basel.