CIMZIA® (certolizumab pegol) has a demonstrated safety profile

Incidence of serious adverse events of interest 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)
  • 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%).