Certolizumab pegol

Certolizumab pegol
Mass / length primary structure	147 kDa
Identifier
External IDs	CAS number : 428863-50-7;
Drug information
ATC code	L04 AB05
Drug class	Immunosuppressant

Certolizumab pegol ( INN ) or Certolizumab for short (trade name Cimzia ; manufacturer UCB ) is a Fab fragment of a recombinant , humanized monoclonal antibody that has been conjugated to polyethylene glycol (see also PEGylation ). The drug acts as a TNF blocker and is used to treat inflammatory bowel disease, Crohn's disease and rheumatoid arthritis .

Clinical information

Application areas (indications)

Disposable syringe with 200 mg certolizumab pegol

Certolizumab is used in patients with active Crohn's disease who have been unsuccessful with the usual treatment. The drug can be used to stimulate a clinical response as well as to maintain a clinical response and remission .

Certolizumab is injected .

Other Information

History

Certolizumab was first mentioned in the literature in 2002. It was initially developed by Celltech and Pharmacia and was transferred to UCB with the takeover of Celltech .

Certolizumab was first approved in Switzerland on September 7, 2007 as an effective component of a drug for the treatment of Crohn's disease. The US approval followed in spring 2008 for the same area of application . In Europe, the European Medicines Agency rejected a recommendation for approval, even after an objection .

US approval for rheumatoid arthritis was granted in May 2009. In October 2009, the approval by the European Commission for the EU member states followed.

Studies

The approvals for Crohn's disease are based on the studies PRECiSE1 and PRECiSE2, while the US approval for rheumatoid arthritis is based on four studies, three of which have been published to date.

Web links

Entries in the NIH study registry
Public Assessment Report (EPAR) of the European Medicines Agency (EMA) for: Certolizumab pegol

Individual evidence

↑ EH Choy, B. Hazleman, M. Smith et al. a .: Efficacy of a novel PEGylated humanized anti-TNF fragment (CDP870) in patients with rheumatoid arthritis: a phase II double-blinded, randomized, dose-escalating trial . In: Rheumatology , 41, 2002, pp. 1133-1137. PMID 12364632 .
^ S. Rose-John, H. Schooltink: CDP-870. Celltech / Pfizer . In: Curr Opin Investig Drugs , 4, 2003, pp. 588-592. PMID 12833654 .
↑ Questions and Answers on the Recommended Refusal of Marketing Authorization for Cimzia. European Medicines Agency; Retrieved August 13, 2008.
↑ WJ Sandborn, BG Feagan, p Stoinov u. a .: Certolizumab pegol for the treatment of Crohn's disease. In: N Engl J Med . 357, 2007, pp. 228-238. PMID 17634458 ; doi: 10.1056 / NEJMoa067594 .
↑ S. Schreiber, M. Khaliq-Kareemi, IC Lawrance a. a .: Maintenance therapy with certolizumab pegol for Crohn's disease. In: N Engl J Med. , 357, 2007, pp. 239-250. PMID 17634459 ; doi: 10.1056 / NEJMoa062897 .
↑ E. Keystone, D. Heijde, D. Mason Jr and a .: Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. In: Arthritis Rheum . , 58, 2008, pp. 3319-3329. Erratum in: Arthritis Rheum. , 60, 2009, p. 1249. PMID 18975346
^ R. Fleischmann, J. Vencovsky, RF van Vollenhoven u. a .: Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. In: Ann Rheum Dis . , 68, 2009, pp. 805-811. PMID 19015206 ; doi: 10.1136 / ard.2008.099291 .
↑ J. Smolen, RB Landewé, P. Mease, J. Brzezicki, D. Mason, K. Luijtens, RF van Vollenhoven, A. Kavanaugh, M. Schiff, GR Burmester, V. Strand, J. Vencovsky, D. van der Heijde: Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomized controlled trial. In: Ann Rheum Dis. , 68, 2009, pp. 797-804. PMID 19015207 ; doi: 10.1136 / ard.2008.101659 .

[1] EH Choy, B. Hazleman, M. Smith et al. a .: Efficacy of a novel PEGylated humanized anti-TNF fragment (CDP870) in patients with rheumatoid arthritis: a phase II double-blinded, randomized, dose-escalating trial . In: Rheumatology , 41, 2002, pp. 1133-1137. PMID 12364632 .

[2] S. Rose-John, H. Schooltink: CDP-870. Celltech / Pfizer . In: Curr Opin Investig Drugs , 4, 2003, pp. 588-592. PMID 12833654 .

[3] Questions and Answers on the Recommended Refusal of Marketing Authorization for Cimzia. European Medicines Agency; Retrieved August 13, 2008.

[4] WJ Sandborn, BG Feagan, p Stoinov u. a .: Certolizumab pegol for the treatment of Crohn's disease. In: N Engl J Med . 357, 2007, pp. 228-238. PMID 17634458 ; doi: 10.1056 / NEJMoa067594 .

[5] S. Schreiber, M. Khaliq-Kareemi, IC Lawrance a. a .: Maintenance therapy with certolizumab pegol for Crohn's disease. In: N Engl J Med. , 357, 2007, pp. 239-250. PMID 17634459 ; doi: 10.1056 / NEJMoa062897 .

[6] E. Keystone, D. Heijde, D. Mason Jr and a .: Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. In: Arthritis Rheum . , 58, 2008, pp. 3319-3329. Erratum in: Arthritis Rheum. , 60, 2009, p. 1249. PMID 18975346

[7] R. Fleischmann, J. Vencovsky, RF van Vollenhoven u. a .: Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. In: Ann Rheum Dis . , 68, 2009, pp. 805-811. PMID 19015206 ; doi: 10.1136 / ard.2008.099291 .

[8] J. Smolen, RB Landewé, P. Mease, J. Brzezicki, D. Mason, K. Luijtens, RF van Vollenhoven, A. Kavanaugh, M. Schiff, GR Burmester, V. Strand, J. Vencovsky, D. van der Heijde: Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomized controlled trial. In: Ann Rheum Dis. , 68, 2009, pp. 797-804. PMID 19015207 ; doi: 10.1136 / ard.2008.101659 .