What Is Cimzia?
Cimzia (certolizumab pegol) is a TNF (tumor necrosis factor) blocker -- the same class of drugs as Enbrel, Remicade, Humira, and Simponi. 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 (RA).
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., says that the unique chemical properties of Cimzia could make it a better drug than existing TNF blockers for RA patients in that its makeup could reduce injection-related adverse reactions and perhaps get the drug to the sites of inflammation better, requiring less frequent dosing than other injectibles.
After initial doses, there is a flexible dosing schedule. Cimzia can be given at intervals of two or four weeks -- either alone or with methotrexate.
How Has Cimzia Performed in Clinical Trials?
Positive clinical trial results have been reported for Cimzia. Two phase III studies, published in the online edition of the Annals of the Rheumatic Diseases in November 2008 showed significant benefit when Cimzia was used alone or in combination with methotrexate in adults with active rheumatoid arthritis (implies there is active synovitis).
Specifically, the 6-month FAST 4WARD 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 have shown 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 Have Been Associated With Cimzia?
Serious side effects have developed in patients 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 and Available?
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. Cimzia is available in a patient-friendly, 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).
Cimzia Effective in Reducing Signs and Symptoms of Rheumatoid Arthritis. UCB. June 14, 2007.
Cimzia. Medication Guide. UCB, Inc. 4/2008.
UCB Receives Complete Response Letter from U.S. FDA for Use of Cimzia in Rheumatoid Arthritis Patients. UCB Press Release. January 5, 2009.
UCB's Cimzia (certolizumab pegol) Approved by U.S. FDA. UCB Press Release. May 14, 2009.