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Int J Immunopathol Pharmacol. 2008 Apr-Jun;21(2):367-74.

Safety and tolerability of infliximab therapy: suggestions and criticisms based on wide clinical experience.

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  • 1Department of Biomedicine, Immunoallergology Unit, Policlinico di Careggi, Viale Morgagni 85, Florence, Italy.


Infliximab, an IgG1 monoclonal chimeric antibody against tumor necrosis factor (TNF)-alpha, represents the main biological drug employed for the treatment of several immuno-mediated inflammatory disorders. Infliximab infusion can be complicated by clinically heterogeneous adverse reactions, potentially interfering with the course of treatment. We analysed the adverse events recorded in 49 patients affected by different chronic inflammatory disorders (rheumatoid arthritis, seronegative spondyloarthritis, Beh├žet's disease, Wegener's granulomatosis, Churg-Strauss syndrome, Cogan's disease) who were receiving a total of 709 infliximab infusions, in order to correlate the development of infliximab reactions and their features to some potential risk factors. We displayed a lower frequency of infusion reactions (1.5 percent; 11 out of 709 infusions) than those previously reported. However, patients suffering from rheumatoid arthritis and/or patients who underwent re-treatment after a long period, showed a higher prevalence of infliximab-related reactions. In conclusion, in our experience infliximab treatment is rarely complicated by adverse reactions which are, more importantly, almost always mild. Some good clinical practices, such as the low rate of infusion, pre-treatment with anti-histamine and prednisone in all patients, chronic immunosuppressive therapy and avoidance of long intervals between infusions may represent a combined useful strategy to reduce the frequency of infliximab reactions and to increase safety.

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