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.
- 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