Certolizumab pegol
Pharmaceutical drug
From Wikipedia, the free encyclopedia
Certolizumab pegol, sold under the brand name Cimzia, is a biopharmaceutical medication for the treatment of Crohn's disease,[3][4] rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. It is a fragment of a monoclonal antibody specific to tumor necrosis factor alpha (TNF-α) and is manufactured by UCB.[5][6][1]
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 Syringe with 200mg Certolizumab pegol | |
| Monoclonal antibody | |
|---|---|
| Type | Fab' fragment |
| Source | Humanized (from mouse) |
| Target | TNF alpha |
| Clinical data | |
| Trade names | Cimzia |
| Other names | CDP870 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a608041 |
| License data | |
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| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Elimination half-life | about 11 days |
| Excretion | Kidney (PEG only) |
| Identifiers | |
| CAS Number | |
| DrugBank | |
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| UNII | |
| KEGG | |
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| Chemical and physical data | |
| Formula | C2115H3252N556O673S16 |
| Molar mass | 47749.46 g·mol−1 |
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Certolizumab pegol is a therapeutic alternative on the World Health Organization's List of Essential Medicines.[7]
Medical uses
- Crohn's Disease
- On April 22, 2008, the U.S. Food and Drug Administration (FDA) approved Cimzia for the treatment of Crohn's disease in people who did not respond sufficiently or adequately to standard therapy.[6][8][9]
- Rheumatoid arthritis
- On June 26, 2009, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending that the European Commission grant a marketing authorisation for Cimzia for the treatment of rheumatoid arthritis only - the CHMP refused approval for the treatment of Crohn's disease. The marketing authorisation was granted to UCB Pharma SA in October 2009.[2]
- Psoriatic arthritis
- On September 27, 2013, the U.S. FDA approved Cimzia for the treatment of adult patients with active psoriatic arthritis.[10]
Method of action
Certolizumab pegol is a monoclonal antibody directed against tumor necrosis factor alpha. More precisely, it is a PEGylated Fab' fragment of a humanized TNF inhibitor monoclonal antibody.[12]
Clinical trials
- Crohn's disease
- Positive results have been demonstrated in two phase III trials (PRECiSE 1 and 2) of certolizumab pegol versus placebo in moderate to severe active Crohn's disease.[3][12][13][14]
- Axial spondyloarthritis
- In 2013, a phase 3 double blind randomized placebo-controlled study found significantly positive results in patient self-reported questionnaires, with rapid improvement of function and pain reduction, in patients with axial spondyloarthritis.[15]
- Rheumatoid arthritis
- Certolizumab appears beneficial in those with rheumatoid arthritis.[16]
