SAFETY DATA FROM CONTROLLED RA CLINICAL TRIALS AND OPEN-LABEL EXTENSIONS

Placebo-Controlled Studies

  • These data are based on 938 patients treated during a 24-week period in Phase 2 and Phase 3 studies of Rituxan (2 x 1000 mg) or placebo administered in combination with methotrexate[13]

Long-Term Data From Follow-up Analysis in the Rituxan Prescribing Information

  • 2578 patients with RA were treated with Rituxan in controlled and long-term studies with a total exposure of 5014 patient-years over a period of 7 years[13,15]

Additional Long-Term Data From Follow-Up Analysis

  • As of September 2012, 3595 patients had been treated with up to 20 courses of RItuxan over a period of 11 years, providing 14,816 patient-years of observation in the All-Exposure population[17]

  • The number of patients available for analysis was[17]:

    • Rituxan All-Exposure: 3595 (14,816 patient-years)

    • Long-term population (>5 years): 1246 (8970 patient-years)

    • Pooled placebo group: 818 (1107 patient-years)