CIMZIA® (certolizumab pegol): Incidence of serious adverse events in CIMZIA clinical trials (per 100 patient-years)1,5

  CIMZIA Placebo
TUBERCULOSIS (IN COMPLETED AND
ONGOING CLINICAL
STUDIES*)
0.61
(n=5118)
0
(n=1563)
MALIGNANCIES
(IN CLINICAL TRIALS*)
0.5 (0.4-0.7)
(n=4650)
0.6 (0.1-1.7)
(n=1319)
LYMPHOMA
(IN RA CLINICAL TRIALS)
0.09
(0.02-0.27)
(n=2367)
0
(n=647)
  • Including other investigational uses.
  • Includes patients from placebo arms from phase 2 and 3 controlled clinical trials in RA and Crohn's disease.
  • Numbers in parentheses represent a 95% confidence interval.
See Warnings and Precautions, including Boxed Warning, regarding tuberculosis, malignancies, and lymphoma
  • In the controlled RA studies, there were more new cases of serious infection adverse reactions in the CIMZIA treatment groups compared to the placebo groups (0.06 per patient-year for all CIMZIA doses vs 0.02 per patient-year for placebo)1
  • Incidence of serious infections during controlled CD clinical studies was 3% per patient-year for patients treated with CIMZIA and 1% for placebo1
  • Cases of new or worsening congestive heart failure have been reported with TNF blockers, including CIMZIA1
  • In controlled trials in CD and other investigational uses, there was one case of lymphoma among 2657 CIMZIA patients1