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

  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%).
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