Retrospective analysis of adverse drug reactions with infliximab in a department of rheumatology

Infliximab is a chimeric monoclonal antibody against human tumour necrosis factor-alpha (TNFalpha), and has received marketing authorisation for the treatment of both rheumatoid arthritis (RA) and Crohn's disease. The aim of the present survey was to assess retrospectively adverse drug reactions (ADRs) in patients treated with infliximab for RA in a rheumatology department of the Toulouse University Hospital (Rangueil Hospital). Among 32 patients included in 2000 and 2001, 43 "expected" ADRs occurred in 21 patients (65.6%) [mean age 51.4 +/- 14.0 years]. In four patients (12.5%), ADRs were classified as "serious". In five other patients, they required the discontinuation of infliximab. We identified mainly infectious (n = 21), allergic (n = 3) and cardiovascular (In = 3) ADRs. Infectious ADRs were as follows: seven urinary infections, with a positive rechallenge (R+) in five; nine respiratory infections, with R+ in five; and five cutaneous infections. An acute rise in blood pressure occurred in three patients who had already been treated with antihypertensive drugs. The incidence of ADRs was as follows: respiratory 28.0%; urinary 22.0%; cutaneous 15.6%; allergic 9.4 %; and cardiovascular 9.4%. In conclusion, our data allowed a quantitative and qualitative assessment of infliximab-induced ADRs. Further studies are required in order to improve knowledge regarding ADRs induced by longterm treatment with infliximab.