Meta-analysis: The efficacy and safety of certolizumab pegol in Crohn's disease

Alimentary Pharmacology and Therapeutics

Volumn 29, Issue 6, 2009, Pages 605-614

  Shao, L M ^a   Chen, M Y ^a   Chen, Q Y ^a   Cai, J T ^a  

^a ZHEJIANG UNIVERSITY   (China)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; C REACTIVE PROTEIN; CERTOLIZUMAB PEGOL; INFLIXIMAB; PLACEBO;

ARTICLE; CLINICAL TRIAL; COCHRANE LIBRARY; CONTROLLED CLINICAL TRIAL; CROHN DISEASE; DISEASE EXACERBATION; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG SAFETY; EMBASE; HEART FAILURE; HUMAN; INFECTION; LIVER FAILURE; LYMPHOMA; MEDLINE; META ANALYSIS; NEOPLASM; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; REMISSION; RISK FACTOR; SCISEARCH; SYSTEMATIC REVIEW; TREATMENT DURATION; TUBERCULOSIS;

ANTI-INFLAMMATORY AGENTS; ANTIBODIES, MONOCLONAL; C-REACTIVE PROTEIN; CROHN DISEASE; HUMANS; IMMUNOGLOBULIN FAB FRAGMENTS; POLYETHYLENE GLYCOLS; QUALITY OF LIFE; REMISSION INDUCTION; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 60349103428     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2009.03929.x     Document Type: Article

References (48)

1. Fiocchi C. Inflammatory bowel disease: etiology and pathogenesis. Gastroenterology 1998 115 : 182 205.
2. Shanahan F. Inflammatory bowel disease: immunodiagnostics, immunotherapeutics, and ecotherapeutics. Gastroenterology 2001 120 : 622 35.
3. Bouma G, Strober W. The immunological and genetic basis of inflammatory bowel disease. Nat Rev Immunol 2003 3 : 521 33.
4. Cominelli F. Cytokine-based therapies for Crohn's disease - new paradigms. N Engl J Med 2004 351 : 2045 8.
5. Hanauer S, Sandborn W. Management of Crohn's disease in adults. Am J Gastroenterol 2001 96 : 635 43.
6. Travis SP, Stange EF, Lémann M, et al. European evidence based consensus on the diagnosis and management of Crohn's disease: current management. Gut 2006 55 (Suppl 1 i16 35.
7. Targan SR, Hanauer SB, van Deventer SJ, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. N Engl J Med 1997 337 : 1029 35.
8. Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology 2006 130 : 323 33.
9. Colombel JF, Sandborn WJ, Rutgeerts P, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007 132 : 52 65.
10. Sandborn WJ, Feagan BG, Hanauer SB, et al. An engineered human antibody to TNF (CDP571) for active Crohn's disease: a randomized double-blind placebo-controlled trial. Gastroenterology 2001 120 : 1330 8.
11. Sandborn WJ, Feagan BG, Radford-Smith G, et al. CDP571, a humanised monoclonal antibody to tumour necrosis factor alpha, for moderate to severe Crohn's disease: a randomised, double blind, placebo controlled trial. Gut 2004 53 : 1485 93.
12. Ghosh S, Goldin E, Gordon FH, et al. Natalizumab for active Crohn's disease. N Engl J Med 2003 348 : 24 32.
13. Sandborn WJ, Colombel JF, Enns R, et al. Natalizumab induction and maintenance therapy for Crohn's disease. N Engl J Med 2005 353 : 1912 25.
14. 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 20 : 1337 46.
15. 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 129 : 807 18.
16. Lang L. FDA approves Cimzia to treat Crohn's disease. Gastroenterology 2008 134 : 1819.
17. Nesbitt A, Fossati G, Bergin M, et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti tumor necrosis factor alpha agents. Inflamm Bowel Dis 2007 13 : 1323 32.
18. Peyrin-Biroulet L, Deltenre P, de Suray N, et al. Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol 2008 6 : 644 53.
19. Behm BW, Bickston SJ. Tumor necrosis factor-alpha antibody for maintenace of remission in Crohn's disease. Cochrane Database Syst Rev 2008 : CD006893.
20. Schreiber S, Hanauer SB, Feagan BG, et al. Long-term treatment with certolizumab pegol for up to 18 months in patients with active Crohn's disease: PRECiSE 3 efficacy results. Gastroenterology 2007 132 : A504.
21. Sandborn WJ, Hanauer SB, Rutgeerts PJ, et al. Re-induction and maintenance therapy with subcutaneous certolizumab pegol in patients with Crohn's disease following treatment failure: PRECiSE 4 results. Gastroenterology 2007 132 : A505.
22. Vermeire S, Abreu MT, D'Haens G, et al. Efficacy and safety of certolizumab pegol in patients with active Crohn's disease who previously lost response or were intolerant to infliximab: open-label induction preliminary results of the WELCOME study. Gastroenterology 2008 134 : A67.
23. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996 17 : 1 12.
24. Moher D, Pham B, Jones A, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 1998 352 : 609 13.
25. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med 2007 357 : 228 38.
26. Blick SK, Curran MP. Certolizumab pegol: in Crohn's disease. BioDrugs 2007 21 : 195 201.
27. Su C, Lichtenstein GR, Krok K, et al. A meta-analysis of the placebo rates of remission and response in clinical trials of active Crohn's disease. Gastroenterology 2004 126 : 1257 69.
28. Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med 2007 357 : 239 50.
29. Abreu MT. Crohn's disease in patients who fail infliximab therapy: what does the future hold? Rev Gastroenterol Disord 2007 7 (Suppl 1 S20 6.
30. Rutgeerts P, Feagan BG, Lichtenstein GR, et al. Comparison of scheduled and episodic treatment strategies of infliximab in Crohn's disease. Gastroenterology 2004 126 : 402 13.
31. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002 359 : 1541 9.
32. Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med 2007 146 : 829 38.
33. Danese S, Mocciaro F, Guidi L, et al. Successful induction of clinical response and remission with certolizumab pegol in Crohn's disease patients refractory or intolerant to infliximab: a real-life multicenter experience of compassionate use. Inflamm Bowel Dis 2008 14 : 1168 70.
34. Vermeire S, Van Assche G, Rutgeerts P. C-reactive protein as a marker for inflammatory bowel disease. Inflamm Bowel Dis 2004 10 : 661 5.
35. Vermeire S, Van Assche G, Rutgeerts P. Laboratory markers in IBD: useful, magic, or unnecessary toys? Gut 2006 55 : 426 31.
36. Boirivant M, Leoni M, Taricotti D, et al. The clinical significance of serum C reactive protein levels in Crohn's disease. J Clin Gastroenterol 1988 10 : 401 5.
37. Buckell N, Leonnard-Jones J, Hernandez M, et al. Measurement of serum proteins during attacks of ulcerative colitis as a guide to patient management. Gut 1979 20 : 22 7.
38. Jones J, Loftus EV Jr., Panaccione R, et al. Relationships between disease activity and serum and fecal biomarkers in patients with Crohn's disease. Clin Gastroenterol Hepatol 2008 6 : 1218 24.
39. Oikonomou I, Shen B. Are we moving forward in the biological treatment of Crohn's disease? Time will tell. Inflamm Bowel Dis 2006 12 : 147 9.
40. Nielsen OH, Vainer B, Madsen SM, et al. Established and emerging biological activity markers of inflammatory bowel disease. Am J Gastroenterol 2000 95 : 359 67.
41. Langhorst J, Elsenbruch S, Koelzer J, et al. Noninvasive markers in the assessment of intestinal inflammation in inflammatory bowel diseases: performance of fecal lactoferrin, calprotectin, and PMN-elastase, CRP, and clinical indices. Am J Gastroenterol 2008 103 : 162 9.
42. Casellas F, Lopez-Vivancos J, Badia X, et al. Influence of inflammatory bowel disease on different dimensions of quality of life. Eur J Gastroenterol Hepatol 2001 13 : 567 72.
43. Guyatt GH, Mitchell A, Irvine EJ, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology 1989 96 : 804 10.
44. Irvine EJ, Feagan B, Rochon J, et al. Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Gastroenterology 1994 106 : 287 96.
45. Rutgeerts P, Schreiber S, Feagan B, et al. Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFalpha, improves health-related quality of life in patients with moderate to severe Crohn's disease. Int J Colorectal Dis 2008 23 : 289 96.
46. Loftus EV Jr. Biologic therapy in Crohn's disease: review of the evidence. Rev Gastroenterol Disord 2007 7 (Suppl 1 S3 12.
47. Sandborn WJ. Clinical perspectives in Crohn's disease. Moving forward with anti-TNF-alpha therapy: current needs and future treatments. Rev Gastroenterol Disord 2007 7 (Suppl 2 S23 35.
48. Lichtenstein GR, Colombel JF, Bloomfield R, et al. Long-term safety of an anti-TNF drug by duration of exposure compared to non-anti-TNF exposed patients with Crohn's disease: novel data from the certolizumab pegol development program. Gastroenterology 2008 134 : A68.