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Table 1 Tocilizumab-associated adverse events

From: Effectiveness of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease-modifying antirheumatic drugs (TOPIRA): study protocol for a pragmatic trial

CategoryAdditional criteria
Serious and/or medically significant infectionsOpportunistic infections
Infections treated with intravenous (IV) anti-infectives
Myocardial infarction (MI)/ acute coronary syndrome (ACS)All MI/ACS events
Gastrointestinal perforationsGastrointestinal perforation includes related fistulae and related intra-abdominal abscesses
MalignanciesAll malignancies
Anaphylaxis/hypersensitivity reactionsAnaphylaxis as per Sampson’s criteria [26]
Hypersensitivity based on investigators’ medical judgment
Demyelinating disordersAll demyelinating disorders
StrokeIncludes stroke and transient ischemic attack (TIA) events
Serious and/or medically significant bleeding eventsBleeding requiring transfusion
Bleeding with hospital visit for evaluation (including emergency department for outpatient clinic)
Serious and/or medically significant hepatic eventsEvent with hepatic clinical diagnosis
Meets hepatic laboratory criteria for Hy’s Lawa
Hepatic laboratory abnormality resulting in TCZ withdrawal (i.e., permanent discontinuation of TCZ therapy)
  1. a ALAT or ASAT concentrations greater than three times the upper limit AND serum bilirubin greater than two times the upper limit (without cholestasis) AND no other reason than the medication to explain these values