Certolizumab pegol
| Monoclonal antibody | |
|---|---|
| Type | Fab' fragment |
| Source | Humanized (from mouse) |
| Target | TNF alpha |
| Clinical data | |
| Trade names | Cimzia |
| AHFS/Drugs.com | Consumer Drug Information |
| MedlinePlus | a608041 |
| Pregnancy cat. | B (US) |
| Legal status | ℞-only (US) |
| Routes | Subcutaneous |
| Identifiers | |
| CAS number | 428863-50-7  |
| ATC code | L04AB05 |
| UNII | UMD07X179E |
| KEGG | D03441  |
| ChEMBL | CHEMBL1201831 |
| Chemical data | |
| Formula | C2115H3252N556O673S16 |
| Mol. mass | 47.75 kDa |
| (what is this?) (verify) | |
Certolizumab pegol [1] (CDP870, tradename Cimzia) is a therapeutic monoclonal antibody to tumor necrosis factor alpha (TNF-α), for the treatment of Crohn's disease[2] and rheumatoid arthritis, manufactured by UCB.[3][4][5]
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.[6]
Polyethylene glycol does not cross the placenta, so it should be safe in pregnancy.[citation needed]
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.[2][6][7][8] 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 and 2 phase III studies were also reportedly positive.[9][10]
In 2013, a phase 3 double blind randomized placebo-controlled study found significantly positive result in patient self-reported questionnaires, with rapid improvement of function and pain reduction. [11]
Legal status
On April 22, 2008, the U.S. Food and Drug Administration (FDA) approved Cimzia for use in the United States for the treatment of Crohn's disease in people who did not respond sufficiently or adequately to standard therapy.[4][12][13]
On June 26, 2009, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) 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 on October 1, 2009.[14]
On September 27, 2013, the U.S. Food and Drug Administration (FDA) approved Cimzia for use in the United States for the treatment of adult patients with active psoriatic arthritis.[15]
References
- ↑ Goel, Niti; Sue Stephens (2010). "Certolizumab pegol". MAbs 2 (2): 137–147. doi:10.4161/mabs.2.2.11271. PMC 2840232. PMID 20190560.
- ↑ 2.0 2.1 Sandborn WJ, Feagan BG, Stoinov S, et al. (July 2007). "Certolizumab pegol for the treatment of Crohn's disease". N. Engl. J. Med. 357 (3): 228–38. doi:10.1056/NEJMoa067594. PMID 17634458.
- ↑ Kaushik VV, Moots RJ (April 2005). "CDP-870 (certolizumab) in rheumatoid arthritis". Expert opinion on biological therapy 5 (4): 601–6. doi:10.1517/14712598.5.4.601. PMID 15934837.
- ↑ 4.0 4.1 "Cimzia Label and Approval History". Drugs@FDA. U.S. Food and Drug Administration (FDA). Retrieved 2009-11-15.
- ↑ "Cimzia Medication Guide" (PDF). U.S. Food and Drug Administration (FDA). May 2009. Retrieved 2009-11-15.
- ↑ 6.0 6.1 Schreiber S. et al.,Certolizumab pegol, a humanised anti-TNF pegylated FAb' fragment, is safe and effective in the maintenance of response and remission following induction in active Crohn's disease: a phase 3 study (precise),Gut,2005,54,suppl7,A82
- ↑ Sandborn et al., Certolizumab pegol administered subcutaneously is effective and well tolerated in patients with active Crohn's disease: results from a 26-week, placebo-controlled Phase 3 study (PRECiSE 1),Gastroenterology, 2006,130,A107
- ↑ "New Analysis Shows Cimzia (Certolizumab Pegol) Maintained Remission and Response in Recent Onset Crohn’s Disease" (Press release). UCB. October 23, 2006. Retrieved 2009-11-15.
- ↑ Keystone E, Mason D, Combe B (June 14 , 2007). "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 6 (Suppl 2): 55–b. doi:10.1136/ard.6.1.55. Retrieved 2009-11-15.
- ↑ Kleinman, DM (June 16, 2007). "Certolizumab, First PEGylated TNF-Blocker, May Surpass Older Drugs in Efficacy, Safety". Muskuloskeletal Report. Retrieved 2009-11-15.
- ↑ Sieper J, Tubergen A, Coteur G, Woltering F, Landewe R (May 2013). "PMS50 – Rapid Improvements In Patient-Reported Outcomes With Certolizumab Pegol In Patients With Axial Spondyloarthritis, Including Ankylosing Spondylitis And Non-Radiographic Axial Spondyloarthritis: 24-Week Results Of A Phase 3 Double Blind Randomized Placebo-Controlled Study". Value in Health 16 (3): A227. doi:10.1016/j.jval.2013.03.1150. Retrieved 2013-05-18.
- ↑ 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 2008-05-01.
- ↑ "Cimzia European Public Assessment Report". European Medicines Agency. Retrieved November 15, 2009.
- ↑ "Cimzia (certolizumab pegol) approved by the U.S. FDA for treatment of adult patients with active psoriatic arthritis". Retrieved October 1, 2013.
External links
- certolizumab pegol at the US National Library of Medicine Medical Subject Headings (MeSH)
- Cimzia Website