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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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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


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.


IR = incidence rate.

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