Table 2

Common SAE in tocilizumab-treated RA patients

No of events
(/100 patient-years)
Infections and infestations163(9.09)
 Herpes zoster11(0.61)
 Atypical mycobacterial infection9(0.50)
 Arthritis bacterial and arthritis infective9(0.50)
Pneumocystis jiroveci pneumonia5(0.28)
 Sepsis and septic shock5(0.28)
 Breast cancer2(0.11)
 Gastric cancer2(0.11)
 B-cell lymphoma1(0.06)
 Basal cell carcinoma1(0.06)
 Bile duct cancer1(0.06)
 Bladder neoplasm1(0.06)
 Pleural mesothelioma1(0.06)
 Uterine cancer1(0.06)
 Large intestine carcinoma1(0.06)
 Cervix carcinoma1(0.06)
 Lung neoplasm1(0.06)
 Cardiac function disorder25(1.39)
 ILD and organising pneumonia23(1.28)
 White blood cell count decreased15(0.84)
 Hepatobiliary disorder12(0.67)
 Neutrophil count decreased10(0.56)
 Anaphylactic reaction, anaphylactic shock,
anaphylactoid reaction and hypersensitivity
 Gastrointestinal perforation7(0.39)
 Acute myocardial infarction6(0.33)
 Vertebral compression fracture6(0.33)
 Cerebral infarction5(0.28)
 Disseminated intravascular coagulation4(0.22)
  • * Pneumonia: includes bronchial pneumonia, lobar pneumonia, pneumonia, mycoplasmal pneumonia, primary atypical pneumonia, bacterial pneumonia and pneumococcal pneumonia.

  • Tuberculosis: pulmonary tuberculosis in three of the patients and peritoneal tuberculosis in one.

  • Gastrointestinal perforations: includes appendicitis perforated, gastric perforation, intestinal perforation, large intestinal perforation, and small intestinal perforation.

  • ILD, interstitial lung disease; RA, rheumatoid arthritis; SAE, serious adverse event.