Cimzia (certolizumab pegol) - What You Need to Know

Cimzia Is a TNF Blocker Used for Inflammatory Arthritis

Nurse with vial of medication and syringe.
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Cimzia (certolizumab pegol) is a TNF (tumor necrosis factor) blocker—the same drug class as Enbrel (etanercept), Remicade (infliximab), Humira (adalimumab), and Simponi (golimumab). Cimzia is the only drug in the TNF class that touts being less poisonous to cells because of its chemical properties (e.g., PEGylated, Fc region free). In addition, compared to other TNF blockers, Cimzia reportedly has a higher affinity for human TNF.

What Is TNF?

It helps to know what TNF is so you can better understand why Cimzia works to block it. TNF is a cytokine, essentially a molecular messenger between cells, that plays a role in the inflammatory process. Excess TNF-alpha production by the body has been linked to several diseases and conditions, including rheumatoid arthritis.

How Is Cimzia Given?

Cimzia is injected under the skin. It is supplied as a powder that must be reconstituted into a liquid formulation so it can be given as a subcutaneous injection.

Its maker, UCB, Inc., stated that the unique chemical properties of Cimzia may make it a better option than existing TNF blockers for rheumatoid arthritis patients. Its makeup may reduce injection-related adverse reactions and drug delivery to inflammation sites may be improved, requiring less frequent dosing than other injectables.

After the initial dose, there is a flexible dosing schedule.

Cimzia can be given at intervals of two or four weeks—either alone or with methotrexate.

How Did Cimzia Perform in Clinical Trials?

Positive clinical trial results were reported for Cimzia. Two phase III studies showed significant benefit when Cimzia was used alone or in combination with methotrexate in adults with active rheumatoid arthritis (i.e., active synovitis).

Specifically, the 24 week FAST4WARD study showed that 400 mg of Cimzia, given every 4 weeks subcutaneously, significantly reduced pain and signs and symptoms of rheumatoid arthritis and improved physical function compared to those on placebo.

The RAPID studies revealed the benefit of using Cimzia together with methotrexate. RAPID1 showed long-term benefit in using Cimzia in terms of symptom relief, improving productivity and quality of life, and lessening fatigue. A second RAPID study, known as RAPID2, showed that Cimzia along with methotrexate significantly improved signs and symptoms of rheumatoid arthritis, inhibited progression of the disease, and improved physical function in patients with active rheumatoid arthritis.

What Side Effects Are Associated With Cimzia?

Serious side effects have developed in some people taking Cimzia. The prescribing information available for Cimzia warns about:

  • serious infections, including tuberculosis
  • cancer, including lymphoma
  • nervous system problems, including multiple sclerosis
  • allergic reactions
  • blood problems
  • new or worsening heart failure
  • immune reactions, including lupus-like syndrome

The most common side effects associated with Cimzia are upper respiratory infections, urinary tract infections, joint pain, and injection site reactions.

Is Cimzia FDA-Approved?

On April 22, 2008, Cimzia was FDA-approved to treat moderate to severely active Crohn's disease in adults who have not been helped by usual treatments. On May 14, 2009, Cimzia was approved by the FDA to treat adult patients who have moderately to severely active rheumatoid arthritis. Indications have also been added for psoriatic arthritis and ankylosing spondylitis.

Cimzia is available in a pre-filled syringe that carries the Arthritis Foundation's Ease-of-Use Commendation. The design of the syringe is the result of a partnership between UCB and OXO (best known for their line of ergonomic cooking utensils and other user-friendly tools).

Sources:

Cimzia. Full Prescribing Information. UCB. Revised April 2016.
http://www.cimzia.com/assets/pdf/Prescribing_Information.pdf

Cimzia. Medication Guide. UCB, Inc. Revised April 2016.
http://www.cimzia.com/assets/pdf/MedicationGuide.pdf

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