Certolizumab pegol (Cimzia) is a humanized tumor necrosis factor alpha (TNF-α) antibody that binds and neutralizes human TNF-α, a cytokine that plays a key role in the immune response. It is coupled to polyethylene glycol (pegol) to lengthen the time it is active within the body. Cimzia is indicated (approved for use) for the treatment of adults with moderately to severely active RA, as well as for the treatment of Crohn’s disease.
Certolizumab (Cimzia): overview and efficacy
Certolizumab pegol (Cimzia) is a humanized tumor necrosis factor alpha (TNF-α) antibody that binds and neutralizes human TNF-α, a cytokine that plays a key role in the immune response. To increase the exposure and reduce how quickly the drug clears from the body, a molecule called polyethylene glycol (pegol) is coupled to certolizumab. It is manufactured by UCB, Inc. Cimzia is indicated (approved for use) for the treatment of adults with moderately to severely active RA, as well as for the treatment of Crohn’s disease.1
How does Cimzia work?
Certolizumab pegol (Cimzia) is a humanized tissue necrosis factor alpha (TNF-α) antibody that binds and neutralizes human TNF-α, a cytokine that plays a key role in the immune response. It is coupled to polyethylene glycol (pegol) to lengthen the time it is active within the body. Cimzia is indicated (approved for use) for the treatment of adults with moderately to severely active RA.1
How is Cimzia taken?
Cimzia is taken by subcutaneous (under the skin) injection and requires an initial loading dose of 400 mg (given as two injections of 200 mg each) every 2 weeks for 6 weeks, followed by a maintenance dose of 200 mg every other week. A dose of 400 mg every 4 weeks can also be considered as a maintenance dose.1
If you are giving yourself an injection of Cimzia using a prefilled syringe, make sure you read the booklet “Patient Instructions for Use” that comes with your prefilled syringe kit. You can inject Cimzia into your abdomen or thigh area. If you are giving yourself more than one injection at a time, use a different site for each injection. Make sure that your doctor or nurse instructs you on how to give yourself an injection. Someone you know can help you with your injection. But make sure they have been trained by your doctor or nurse. If you have any questions about administering Cimzia, call your doctor or the Cimzia patient support line listed below.1
If you forget to take a dose of Cimzia, inject the next dose as soon as you remember. Then administer your next dose of Cimzia at the regularly scheduled time. This will get you back on schedule. If you ever have questions about when you should take Cimzia, call your doctor or pharmacist.
Are there people who should not take Cimzia?
There is an increased risk for serious infections with Cimzia. This is because Cimzia can decrease the ability of the immune system to fight infections. Most patients who developed serious infections while taking Cimzia were also receiving immunosuppressant treatments, including methotrexate or corticosteroids.1
If you are taking Cimzia and develop any symptoms of an infection, contact your doctor immediately. Types of serious infections seen with Cimzia include tuberculosis, invasive fungal infections (fungal infections that occur inside the body and include histoplasmosis, coccidioidomycosis, candidaisis, aspergillosis, blastomycosis, and pneumocystosis), and bacterial, viral, and other opportunistic infections (eg. Legionella, Listeria). If you have chronic or recurrent infections, you should carefully weigh the risks and benefits of treatment with Cimzia before starting therapy.1
Cimzia is a pregnancy category B drug. One small study conducted in 10 women who received Cimzia during pregnancy found that there was low transfer of certolizumab pegol through the placenta. Results from animal studies indicated no harm to the fetus when Cimzia was taken during pregnancy. However, because there have been no well-controlled studies in pregnant women, Cimzia should be used during pregnancy only if it is clearly needed.1
It is not known whether Cimzia is excreted into human milk. Because of the risk of adverse effects, women who are taking Cimzia should either not breastfeed their children or discontinue the drug.1
Cimzia should not be used by patients diagnosed with multiple sclerosis or other demyelinating disease.
What is the evidence that Cimzia works in RA?
The effectiveness of Cimzia in RA has been evaluated in four randomized, controlled trials in patients with moderately to severely active RA. In three of these studies, Cimzia was given to patients in combination with methotrexate, and in one study Cimzia was given alone as monotherapy.
Disease control and clinical response. Cimzia alone and in combination with methotrexate resulted in greater percentages of patients achieving disease control (ACR20, 50, and 70) compared with placebo and placebo combined with methotrexate. In one study that included 592 patients who had been treated with methotrexate for at least 6 months with an inadequate response, rates of ACR20 response at 6 months and 1 year for the Cimzia treatment group receiving 200 mg every other week + methotrexate were 59% and 53%, respectively, compared with 14% and 13%, respectively, for the placebo + methotrexate group. Over the course of this 1-year study, 13% of patients who received Cimzia experienced a major clinical response, defined as a ACR70 response maintained continuously over a 6-month period, compared with only 1% of placebo + methotrexate patients.1
In another study conducted in 247 patients who had had an inadequate response to methotrexate despite treatment for at least 6 months, Cimzia given alone as monotherapy at a dose of 400 mg every 4 weeks resulted in a rate of ACR20 response at 6 months of 46% compared with 9% for placebo.1
Disease control (ACR responses) in two Cimzia clinical trials1
|Study of Cimzia plus methotrexate (MTX)||Study of Cimzia as monotherapy|
|Response||Cimzia 200 mg every other week + MTX (N=393)||Placebo + MTX (N=199)||Cimzia 400 mg every 4 weeks (N=111)||Placebo (N=109)|
|Major clinical response*||13%||1%|
|*Defined as ACR70 response sustained continuously over a 6-month period.|
Radiographic response. Patients who received the combination of Cimzia and methotrexate in the study discussed above also had less radiographic progression, as defined as change in Modified Total Sharp Score (mTSS) at 52 weeks from baseline (the start of the study), compared with patients who received placebo plus methotrexate. Among patients in the placebo group, 52% had a change from baseline in TSS of 0 or less compared with 69% in the Cimzia group.1
Radiographic changes from baseline in study of Cimzia + methotexate (MTX) versus placebo + MTX
|Cimzia 200 mg every other week + MTX (N=393)||Placebo + MTX (N=199)|
|Modified Total Sharp Score*|
|Joint space narrowing score*|
|*Change in score from baseline (study start).|
Is there a generic form of Cimzia?
There is no generic equivalent to Cimzia.