Malignancies

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To assess the risk for malignancy associated with CIMZIA, standardized incidence ratios for malignancies in the rheumatoid arthritis (RA) clinical program were calculated.¹ The World Health Organization GLOBOCAN database was used to conduct comparisons with the general population. Results from GLOBOCAN and the National Cancer Institute's SEER (Surveillance, Epidemiology and End Results) program are included.¹

The expected number of cases using GLOBOCAN was approximately 29, compared with 31 observed cases; the calculated standardized incidence ratio (SIR) was 1.06¹
Using the SEER database, almost 36 cases were expected, with 31 observed, the SIR was 0.86¹

*Provides worldwide data on cancer epidemiology. Developed using data from the Descriptive Epidemiology Group of the International Agency for Research on Cancer. Incidence taken from cancer registries. Excludes nonmelanoma skin cancer cases and cancers occurring within 30 days of first injection of study drug.
CI = confidence interval; SIR = standardized incidence ratio.

Incidence taken from cancer registries. Excludes nonmelanoma skin cancer cases and cancers occurring within 30 days of first injection of study drug.

During controlled and open-label portions of CIMZIA studies of Crohn's disease and other diseases, malignancies were observed at a rate (95% confidence interval) of 0.5 (0.4, 0.7) per 100 patient-years among 4650 CIMZIA-treated patients versus a rate of 0.6 (0.1, 1.7) per 100 patient-years among 1319 placebo-treated patients.² In CIMZIA RA clinical trials (placebo-controlled and open label), a total of 3 cases of lymphoma were observed among 2367 patients.²

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Indication
CIMZIA is indicated for the treatment of adults with moderate to severe rheumatoid arthritis (RA).

Important Safety Information
Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients

*Not valid for prescriptions that are reimbursed, in whole or part, under Medicare (including Medicare Part D), Medicaid, similar federal or state funded programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico) or where otherwise prohibited by law. Product dispensed pursuant to program rules and federal and state laws. Claims should not be submitted to any public payor (i.e., Medicare, Medicaid, Medigap, Tricare, VA and DoD) for reimbursement. Patients and pharmacists are responsible for notifying insurance carriers or other third party who pays for or reimburses any part of the prescription filled using this card as may be required by the insurance carrier's terms and conditions and applicable law. The parties reserve the right to amend or end this program at any time without notice.

For more information 1-866-4-CIMZIA (1-866-424-6942)

References:

Data on file. UCB, Inc.; Smyrna, GA.
CIMZIA [prescribing information]. Smyrna, GA: UCB, Inc.; 2012.

CIMZIA^® and CIMplicity^® are trademarks of the UCB Group of Companies.
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Malignancies

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