I read that Cimzia can cause cancer. Is it contraindicated for people with a history of cancer? Mine was very minor (melanoma in situ x2, basal cell carcinoma x4). No chemo or radiation. Just cut it out and I was fine. But since it seems that I'm prone to skin cancers (thanks to my stupid habit of tanning beds), could I have more problems with Cimzia? I'm supposed to start it next week, I believe.
Stephanie - The product labeling for Cimzia states the following regarding cancer:
"In the controlled portions of clinical studies of some TNF blockers, more cases of malignancies have been observed among patients receiving TNF blockers compared to control patients. During controlled and open-labeled portions of CIMZIA studies of Crohn's disease and other diseases, malignancies (excluding non-melanoma skin cancer) were observed at a rate (95% confidence interval) of 0.5 (0.4, 0.7) per 100 patient-years among 4,650 CIMZIA-treated patients versus a rate of 0.6 (0.1, 1.7) per 100 patient-years among 1,319 placebo-treated patients. The size of the control group and limited duration of the controlled portions of the studies precludes the ability to draw firm conclusions.
Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤ 18 years of age), of which CIMZIA is a member. Approximately half the cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months of therapy (range 1 to 84 months). Most of the patients were receiving concomitant immunosuppressants. These cases were reported post-marketing and are derived from a variety of sources including registries and spontaneous post-marketing reports.
In the controlled portions of clinical trials of all the TNF blockers, more cases of lymphoma have been observed among patients receiving TNF blockers compared to control patients. In controlled studies of CIMZIA for Crohn's disease and other investigational uses, there was one case of lymphoma among 2,657 Cimzia-treated patients and one case of Hodgkin's lymphoma among 1,319 placebo-treated patients.
In the CIMZIA RA clinical trials (placebo-controlled and open label) a total of three cases of lymphoma were observed among 2,367 patients. This is approximately 2-fold higher than expected in the general population. Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma.
Rates in clinical studies for CIMZIA cannot be compared to the rates of clinical trials of other TNF blockers and may not predict the rates observed when CIMZIA is used in a broader patient population. Patients with Crohn's disease that require chronic exposure to immunosuppressant therapies may be at higher risk than the general population for the development of lymphoma, even in the absence of TNF blocker therapy [see Adverse Reactions (6.1)]. The potential role of TNF blocker therapy in the development of malignancies in adults is not known.
Cases of acute and chronic leukemia have been reported in association with post-marketing TNF-blocker use in RA and other indications. Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for the development of leukemia.
I think the important portions are "The size of the control group and limited duration of the controlled portions of the studies precludes the ability to draw firm conclusions" and "The potential role of TNF blocker therapy in the development of malignancies in adults is not known".
The Cimzia labeling does not specifically mention a history of cancer as a contraindication.
In addition, there is this from the FDA
Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009
"FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.
TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis."
More information can be found at
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174474.htm
There appears to be an increase in lymphoma in particular associated with TNF agents, especially for children and adolescents, but at this early stage of knowledge of these drugs, the increase is probably small, and it is difficult (again, with the current knowledge) to separate any increases from those associated with the conditions treated with these drugs, such as Crohn's and rheumatoid arthritis. It's impossible to know for certain, of course, whether a history of melanoma & basal cell carcinoma would be likely to increase your risk of developing one of the malignancies primarily associated with TNF's in adults. How old are you? Do you have a family history of lymphoma or leukemia? Are you/will you be using any other immunosuppressive drugs such as azathioprine or methotrexate? Most importantly, have you discussed this with your doctor? What does he or she say?
I'm sure I don't have to tell you that, with your history, it is VITAL that you avoid unnecessary sunlight and ALL tanning beds!
I hope this helps, and again DO bring this up with your doctor, if you haven't already!!!
