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CIMZIA safety profile—rheumatoid arthritis (RA) indication

To date, 2 integrated safety summaries have been conducted for the CIMZIA RA indication1:

  • The original cutoff (August 31, 2007) provided data for 4065 patient-years of exposure
  • The updated cutoff (June 30, 2008) provided data for an additional 844 patient-years of exposure, or 4909 patient-years
Ten RA population studies are included in the pooled database—7 completed studies and 3 ongoing studies, representing 2367 patients (all CIMZIA doses).1

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Serious adverse events

The table below presents serious adverse events for the RA indication associated with longer-term exposure to CIMZIA, by system organ class. Data are presented as the incidence rate per 100 patient-years for each cutoff date.

Overall summary of adverse events

The table below summarizes the overall incidence of adverse events associated with longer-term exposure to CIMZIA. Data are presented as an overall percentage and as the incidence rate per 100 patient-years for each cutoff date, allowing assessment of potential trends from the first cutoff (August 31, 2007) to the second cutoff (June 30, 2008).1


IR = incidence rate.

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