Background Infliximab, a Tumour Necrosis Factor-alpha antagonist monoclonal antibody, is efficient in inflammatory diseases. Although some cases of liver injury have been reported, little information is available about liver injury in infliximab-treated patients.
Objectives The aim of this study was to analyze the time course of ALT in a cohort of real-life infliximab-treated patients and to identify possible factors associated with ALT elevations.
Methods We conducted a retrospective study in patients initiating infliximab between 2005 and 2012 in our department of rheumatology. Patients who presented during follow-up with alanine aminotransferase (ALT) >75 UI/L and ≥100% increase from baseline value, defined as liver injury, were compared with the others. Those who presented with ALT >150 UI/L and ≥100% of the baseline value were studied separately.
Results One hundred and nighty six patients started infliximab during the study period. Liver injury occurred in 39 (20%), 85% during the first year of treatment. Eight patients (4%) discontinued infliximab due to liver injury, representing only 6.6% of all cause of treatment discontinuation. Demographics, disease activity, concomitant treatments and cardiovascular risk factors were not associated with occurrence of liver injury. An increase in ALT >150 UI/L was observed in 8 patients, leading to discontinuation in four. A direct causality was probable in one case.
Conclusions Liver injury occurred in one in five of infliximab-treated patients with inflammatory diseases in clinical practice but was rarely a cause for treatment discontinuation.
Acknowledgements The authors thank Fadela Daoued and Alexis Lhommas for their cooperation for the collection of data. We are indebted to all the clinicians, Isabelle Griffoul, Virginie Martaillé, Emilie Ducourau, Chu Miow Lin, Francine Lauféron, Jean Camille-Méric, Guillaume Direz, Julien Melet, Florence Erny, for their help in collecting adverse events, to Françoise Gouais, Martine Creton, Marie-Françoise Coudray, Fabienne Chapacou, Dominique Guillon, Rodolphe Laurent, Patricia Pitault and Fabienne Georges for blood sampling and taking care for patients and to Alain Saraux and Jean-Marc Perrarnau for advice.
Disclosure of Interest None declared