Background Data on safety in patients exposed to biologic therapies are mainly focused on rheumatoid arthritis (RA). Little is known about the infliximab safety profile in spondyloarthritis (SA).
Objectives The aim of this study was to evaluate the clinical safety of infliximab in everyday practice. We assessed the incidence of adverse events requiring hospitalization, outpatient treatment or therapeutic modifications (stopping or postponing the treatment) in patients with rheumatic diseases (RA and SA). Then we tried to identify risk factors for adverse events.
Methods Retrospective cohort study including the patients treated with infliximab between December, 2005 and January, 2012. We listed all the adverse events, which required an ambulatory treatment or a modification of the treatment with infliximab or a hospitalization. Then, patients with and without adverse events were compared.
Results Two hundred and six patients received 2911 infusions during the period studied. We collected 224 infections with an incidence of serious infection of 5.3 cases for 100 patients/year, 22 skin reactions, 16 gastrointestinal events, 7 neuropsychiatric events and 9 neoplastic events. We did not identify risk factors for this first group of adverse events. We also collected 12 cardiovascular events occurring more frequently in hypertensive patient (p=0,005) and 26 immediate infusion reactions were more frequent in patients developing antibodies toward infliximab (p<0.01), receiving a low dose of infliximab (p=0.01) and with a history of allergy (p=0.01).
Conclusions Adverse events are frequent in patients treated with infliximab with mainly infectious events and infusion reaction events. This work underlines the importance of a clinical follow-up of the patients treated with infliximab and more particularly by anti-TNFα.
Acknowledgements The authors thank Frederic Médina, Sophia Leclerc, Sophie-Anne Fauconnier and Alexis Lhommas for their cooperation for the collection of data and David Ternant for his help in data analysis and his advice for the development of this work.The authors thank Professor Bernard to have reviewed this work.Thanks to the medical and paramedical staff of Department of Rheumatology, pharmaco-toxicology laboratory and hospital pharmacy.
Disclosure of Interest : None declared
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