CIMZIA® (certolizumab pegol) has a demonstrated safety profile
CIMZIA has a safety profile for PsA and AS similar to that seen in RA patients1
Incidence of serious adverse events of interest 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) |
- 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
- Cases of new or worsening congestive heart failure have been reported with TNF blockers, including CIMZIA1
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.
Adverse reactions reported by ≥3% of patients treated with CIMZIA dosed every other week during placebo-controlled period of RA studies, with concomitant methotrexate (MTX)1
| CIMZIA 200 mg EOW + MTX (%) (n=640) |
Placebo + MTX (%) (n=324) |
|
|---|---|---|
| UPPER RESPIRATORY TRACT INFECTION | 6 | 2 |
| HEADACHE | 5 | 4 |
| HYPERTENSION | 5 | 2 |
| NASOPHARYNGITIS | 5 | 1 |
| BACK PAIN | 4 | 1 |
| PYREXIA | 3 | 2 |
| PHARYNGITIS | 3 | 1 |
| RASH | 3 | 1 |
| ACUTE BRONCHITIS | 3 | 1 |
| FATIGUE | 3 | 2 |
- Less than 2% of CIMZIA patients reported injection site pain in RA 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%).
