CIMZIA® (certolizumab pegol) has a demonstrated safety profile
Incidence of serious adverse events of interest
Incidence of serious adverse events in CIMZIA clinical trials (per 100 patient-years)1,5
- To learn more, see safety profile for all indications
| 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) |
- Incidence of serious infections during controlled 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
See Warnings and Precautions, including Boxed Warning, regarding tuberculosis, malignancies, and lymphoma.
- 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.
Common adverse events
Most common adverse reactions (≥5% of CIMZIA-treated patients and with a higher incidence compared to placebo) in controlled CD clinical studies1
| CIMZIA (n=620) |
Placebo (n=614) |
|
|---|---|---|
| Upper respiratory tract infection | 20% | 13% |
| Urinary tract infection | 7% | 6% |
| Arthralgia | 6% | 4% |
- Less than 2% of CIMZIA patients reported injection site burning or stinging in clinical trials2
- In premarketing controlled trials of all patient populations combined, the most common adverse reactions (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%)
