Certolizumab pegol: In Crohn's disease

BioDrugs

Volumn 21, Issue 3, 2007, Pages 195-201

  Blick, Stephanie K A ^a   Curran, Monique P ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; C REACTIVE PROTEIN; CERTOLIZUMAB PEGOL; ETANERCEPT; INFLIXIMAB; PHA 138744; PLACEBO; TUBERCULOSTATIC AGENT; TUMOR NECROSIS FACTOR ALPHA ANTIBODY; UNCLASSIFIED DRUG;

CLINICAL TRIAL; CROHN DISEASE; DRUG DOSE ESCALATION; DRUG HALF LIFE; DRUG TOLERABILITY; HEADACHE; HUMAN; LUNG TUBERCULOSIS; LUPUS VULGARIS; MAINTENANCE THERAPY; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; REVIEW; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION;

ANIMALS; CLINICAL TRIALS, PHASE II; CLINICAL TRIALS, PHASE III; CROHN DISEASE; HALF-LIFE; HUMANS; IMMUNOGLOBULIN FAB FRAGMENTS; POLYETHYLENE GLYCOLS; RANDOMIZED CONTROLLED TRIALS; TUMOR NECROSIS FACTOR-ALPHA;

EID: 34249718925     PISSN: 11738804     EISSN: None     Source Type: Journal    
DOI: 10.2165/00063030-200721030-00006     Document Type: Review

References (24)

1. Anon. Countering Crohn's disease with Cimzia: novel TNF-α blocker close to market. Pharm Diag Innovation 2005; 3 (8): 6-9
2. Sandborn WJ. New concepts in anti-tumor necrosis factor therapy for inflammatory bowel disease. Rev Gastroenterol Disord 2005; 5 (1): 10-8
3. Schreiber S, Rutgeerts P, Fedorak RN, et al. A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease. Gastroenterology 2005 Sep; 129 (3): 807-18
4. Feagan B, Rutgeerts P, Schreiber S, et al. Low baseline CRP correlates with a high placebo remission rate in Crohn's disease (CD) clinical trial at 12 weeks [abstract no. M1092]. Gastroenterology 2005; 128 Suppl. 2: 307
5. Vermeire S, Van Assche G, Rutgeerts P. C-reactive protein as a marker for inflammatory bowel disease. Inflamm Bowel Dis 2004 Sep; 10 (5): 661-5
6. Weir N, Athwal D, Brown D, et al. A new generation of high-affinity humanized PEGylated Fab́ fragment anti-tumor necrosis factor-alpha monoclonal antibodies. Therapy 2006; 3 (4): 535-45
7. US Food and Drug Administration. FDA Approves new treatment For Crohn's disease [online]. Available from URL: http://www.fda.gov/bbs/topics/NEWS/ 2007/NEW01572.html [Accessed 2007 May 15]
8. Choy EH, Hazleman B, Smith M, et al. Efficacy of a novel PEGylated humanized anti-TNF fragment (CDP870) in patients with rheumatoid arthritis: a phase II double-blinded, randomized, dose-escalating trial. Rheumatology (Oxford) 2002 Oct; 41 (10): 1133-7
9. Fossati G, Nesbitt A. Effect of the anti-TNF agents, adalimumab, etanercept, infliximab, and certolizumab pegol (CDP870) on the induction of apoptosis in activated peripheral blood lymphocytes and monocytes. Am J Gastroenterol 2005; 100 Suppl. 9: 298-9
10. Gramlick G, Fossati G, Nesbitt A. Neutralization of soluble and membrane tumor necrosis factor-α (TNF-α) by infliximab, adalimumab, or certolizumab pegol using P55 or P75 TNF-α receptor-specific bioassays. Gastroenterology 2006; 130 Suppl. 2: A-697
11. Gramlick G, Fossati G, Henry A, et al. Assessment of the affinity for soluble TNF and the neutralising potency against soluble and membrane TNF of the anti-TNF agents certolizumab pegol, adalimumab, etanercept and infliximab. Ann Rheum Dis 2006; 65 Suppl. II: 456
12. Vetterlein OM, Kopotsha T, Nesbitt AM, et al. Antibodies to infliximab in patients with Crohn's disease do not cross-react with certolizumab pegol [abstract no. MON-G-261]. Gut 2006; 55 (Suppl. V): A133. Plus poster presented at the 14th United European Gastroenterology Week; 2006 Oct 21-25; Berlin
13. Sandborn WJ, Feagan BG, Stoinov S, 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 III study (PRECiSE I) [abstract no. 745]. Gastroenterology 2006 Apr; 130 (4 Suppl. 2): 107. Plus oral presentation presented at Digestive Disease Week; 2006 May 20-25; Los Angeles
14. Schreiber S, Feagan B, Hanauer SB, et al. Safety and tolerability of subcutaneous certolizumab pegol in active Crohn's disease: results from two phase III studies (PRECiSE program) [abstract no. 1126]. Gastroenterology 2006 Apr; 130 (4 Suppl. 2): 479. Plus poster presented at Digestive Disease Week; 2006 May 20-25; Los Angeles
15. Baker M, Stringer F, Stephens, S. Pharmacokinetic properties of the anti-TNF agent certolizumab pegol [abstract no. THU0195]. Ann Rheum Dis 2006; (65 Suppl. 2): 175. Plus poster presented at the Annual European Congress of Rheumatology; 2006 Jun 21-24; Amsterdam
16. Schreiber S, Khaliq-Kareemi M, Lawrance I, et al. Certolizumab pegol, a pegylated Fab' fragment of a humanised anti-tnf monoclonal antibody, is safe and effective in the maintenance of response and remission following induction in active Crohn's disease: a phase III study (PRECISE 2) [abstract no. SAT0168]. Ann Rheum Dis 2006; 65 Suppl. II: 500
17. Guyatt G, Mitchell A, Irvine EJ, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology 1989 Mar; 96 (3): 804-10
18. Rutgeerts P, Fedorak R, Schreiber S, et al. CDP870, a pegylated humanized anti-TNF antibody fragment, improves quality of life in patients with moderate to severe Crohn's disease [abstract no. T1306]. Gastroenterology 2004 Apr; 126 (4 Suppl. 2): A-466
19. Winter TA, Wright J, Ghosh S, et al. Intravenous CDP870, a PEGylated Fab' fragment of a humanized antitumour necrosis factor antibody, in patients with moderate-to-severe Crohn's disease: an exploratory study. Aliment Pharmacol Ther 2004 Dec; 20 (11-12): 1337-46
20. Feagan B, Coteur G, Keninger DL, et al. Sustained improvement in health-related quality of life following certolizumab pegol 400mg every 4 weeks in patients with crohn's disease: data from PRECiSE 2 [abstract no. MON-G-219]. Gut 2006; 55 (Suppl. V): A124. Plus poster presented at the 14th United European Gastroenterology Week; 2006 Oct 21-25; Berlin
21. Feagan B, Coteur G, Keninger DL, et al. The burden of Crohn's disease on patients-reported health status was relieved following maintenance treatment with certolizumab pegol 400mg every 4 weeks: data from PRECiSE 2 [abstract no. MON-G-220]. Gut 2006; 55 (Suppl. V): A124. Plus poster presented at the 14th United European Gastroenterology Week; 2006 Oct 21-25; Berlin
22. Feagan B, Brown M, Gerlier L, et al. The effects of certolizumab pegol on work productivity and daily activities of Crohn's disease patients: data from PRE-CiSE 2 [abstract no. MON-G-291]. Gut 2006; 55 (Suppl. V): A139. Plus poster presented at the 14th United European Gastroenterology Week; 2006 Oct 21-25; Berlin
23. Schreiber S, Colombel JF, Panes J, et al. Recent-onset Crohn's disease shows higher remission rates and durability of response to treatment with subcutaneous monthly certolizumab pegol: results from an analysis of the PRECiSE 2 phase III study [abstract no. MON-G-255]. Gut 2006; 55 (Suppl V): A131. Plus poster presented at the 14th United European Gastroenterology Week; 2006 Oct 21-25; Berlin
24. Schreiber S, Winter T, Innes A, et al. Safety of CDP870, a pegylated humanised anti-TNF antibody fragment, in Crohn's disease. Gut 2003 Nov; 52 Suppl. 6: 215