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Certolizumab pegol?
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| Therapeutic monoclonal antibody | |
| Source | human |
| Target | ? |
| Identifiers | |
| CAS number | ? |
| ATC code | ? |
| PubChem | ? |
| Chemical data | |
| Formula | ? |
| Mol. mass | ? |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Metabolism | ? |
| Half life | ? |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
B(US) |
| Legal status | |
| Routes | Subcutaneous |
Certolizumab pegol (CDP870, tradename Cimzia) is a therapeutic monoclonal antibody for the treatment of Crohn's disease[1]. It is also investigated for use against rheumatoid arthritis[2].
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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.
Clinical trials
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.citation needed In addition, data from both trials suggest it is well-tolerated. As yet its efficacy has not been directly compared to other anti-TNF-α agents.citation needed
Preliminary results of the RAPID 1 &a 2 phase III studies were also reportedly positive.[3][4]
Legal status
On April 22, 2008, the United States Food and Drug Administration approved the drug for use in the United States on for the treatment of Crohn's disease in people who did not respond sufficiently or adequately to standard therapy.[5][6]
References
- ^ Sandborn WJ, Feagan BG, Stoinov S, et al (2007). "Certolizumab pegol for the treatment of Crohn's disease". N. Engl. J. Med. 357 (3): 228–38. doi:. PMID 17634458.
- ^ Kaushik VV, Moots RJ (2005). "CDP-870 (certolizumab) in rheumatoid arthritis". Expert opinion on biological therapy 5 (4): 601–6. doi:. PMID 15934837.
- ^ Keystone E, Mason D, Combe B. The anti-TNF certolizumab pegol in combination with methotrexate is significantly more effective than methotrexate alone in the treatment of patients with active rheumatoid arthritis: preliminary results from the RAPID 1 study. Ann Rheum Dis 2007;66(Suppl II):55 Presented at: EULAR 2007 Meeting; June 13-16, 2007; Barcelona, Spain. Abstract OP0016
- ^ Denise Mann Kleinman, "Certolizumab, First PEGylated TNF-Blocker, May Surpass Older Drugs in Efficacy, Safety", Muskuloskeletal Report June 16, 2007
- ^ UCB press release - Cimzia® Approved in the US for the Treatment of Moderate to Severe Crohn's Disease. Retrieved April 22, 2008.
- ^ Waknine, Yael (May 1, 2008). "FDA Approvals: Patanase, Actonel, Cimzia". Medscape. Retrieved on 2008-05-01.
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Wikipedia content modification information:
- This page was last modified on 4 September 2008, at 18:44.
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