Table 3

Overview of AE during double-blind treatment (safety population)

No (%) of patients withTocilizumab 8 mg/kg + DMARD (N=409)Placebo + DMARD (N=205)
Any AE290 (70.9)122 (59.5)
Severe AE35 (8.6)13 (6.3)
Serious AE30 (7.3)11 (5.4)
AE leading to treatment withdrawal27 (6.6)8 (3.9)
AE leading to dose modification/interruption53 (13.0)12 (5.9)
  • * Two deaths were considered possibly related to drug treatment: (1) Sepsis (73-year-old white/Hispanic woman with multiple comorbidities, with concomitant medications including methotrexate, coumadin, folic acid and metoprolol, who received her last dose of tocilizumab on 10 June 2008; she was diagnosed with a urinary tract infection on 30 June, pneumonia on 1 July, and died of septic shock on 18 July); and (2) Haemorrhagic stroke (74-year-old white man with dyspepsia as the only reported comorbidity, with concomitant medications including methotrexate, prednisone, Advil, calcium, multivitamins, folic acid, Prilosec and ibuprofen, who received his last dose of tocilizumab on 8 July 2008, and died of haemorrhagic stroke with underlying interstitial lung disease on 4 August). A third death, from coronary artery arteriosclerosis, was considered by the investigator to be unrelated to study treatment.

  • AE, adverse event; DMARD, disease-modifying antirheumatic drugs.