Table 2

Safety at week 104 (safety population)

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  • Events that occurred while patients were receiving escape therapy are included in the group in which they occurred.

  • *Three opportunistic infections occurred during the second year in two patients receiving 8 mg/kg TCZ+MTX and in one patient receiving 8 mg/kg TCZ+placebo. There were two cases of primary pulmonary tuberculosis: one SAE in the 8 mg/kg TCZ+MTX group in year 1 (case originated from Europe; patient had exposure to a patient with active tuberculosis) and one AE in a patient in the placebo+MTX group who had an unknown history of tuberculosis and who received escape therapy in year 2.

  • †The patient in the placebo+MTX group had perforated appendicitis approximately 10 months after starting the study. The patient in the 8 mg/kg TCZ+placebo group had diverticulitis complicated by GI perforation 18 months after starting treatment.

  • ‡As identified by cirrhosis, fibrosis, hepatic failure and other liver damage-related conditions. Based on standardised Medical Dictionary for Regulatory Activities queries.

  • AEs, adverse events; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GI, gastrointestinal; MTX, methotrexate; PY, patient-years, SAEs, serious adverse events; TCZ, tocilizumab; ULN, upper limit of normal.