[Retrospective analysis of adverse effects of infliximab in a hospital rheumatology service].
Infliximab is a chimeric monoclonal antibody against human tumour necrosis factor-alpha (TNF alpha), and has received marketing authorization 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 (n = 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 long-term treatment with infliximab.
Cabou
Cendrine
C
Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Centre Hospitalier Universitaire, Faculté de Médecine, Toulouse, France.
Bagheri
Haleh
H
Cantagrel
Alain
A
Mazières
Bernard
B
Montastruc
Jean-Louis
JL
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000188:drug therapy; D001424:Bacterial Infections / Q000453:epidemiology / Q000209:etiology*; D004342:Drug Hypersensitivity / Q000453:epidemiology / Q000209:etiology; D004359:Drug Therapy, Combination; D005260:Female; D006748:Hospital Departments / Q000706:statistics & numerical data; D006785:Hospitals, University / Q000706:statistics & numerical data; D006801:Humans; D006973:Hypertension / Q000139:chemically induced* / Q000453:epidemiology; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012219:Rheumatology / Q000706:statistics & numerical data; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors / Q000276:immunology
D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab