Efficacy and safety of certolizumab pegol in an unselected crohn's disease population: 26-week data of the FACTS II survey

Inflammatory Bowel Diseases

Volumn 17, Issue 7, 2011, Pages 1530-1539

  Vavricka, Stephan R ^a,b   Schoepfer, Alain M ^c,d   Bansky, Georg ^f   Binek, Janek ^e   Felley, Christian ^g   Geyer, Martin ^h   Manz, Michael ⁱ   Rogler, Gerhard ^a   De Saussure, Philippe ^j   Sauter, Bernhard ^k   Scharl, Michael ^a   Seibold, Frank ^d   Straumann, Alex ^l   Michetti, Pierre ^g  

^a UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^b Division of Gastroenterology   (Switzerland)

^c MCMASTER UNIVERSITY   (Canada)

^d UNIVERSITY OF BERN   (Switzerland)

^e Private Practice   (Switzerland)

^f CANTONAL HOSPITAL ST GALLEN   (Switzerland)

^g LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^h Private Practice   (Switzerland)

ⁱ UNIVERSITY HOSPITAL BASEL   (Switzerland)

^j Private Practice   (Switzerland)

^k KLINIK HIRSLANDEN   (Switzerland)

^l Private Practice   (Switzerland)

more..

Author keywords

anti TNF ; certolizumab pegol; Crohn's disease; perianal fistulizing disease

Indexed keywords

ADALIMUMAB; AMOXICILLIN PLUS CLAVULANIC ACID; AZATHIOPRINE; BUDESONIDE; CERTOLIZUMAB PEGOL; CIPROFLOXACIN; INFLIXIMAB; ISONIAZID; MERCAPTOPURINE; METHOTREXATE; METRONIDAZOLE; PREDNISONE;

ADULT; AGED; ANTIBIOTIC THERAPY; ANUS FISTULA; ARTICLE; BLEEDING; CLINICAL PRACTICE; CLOSTRIDIUM DIFFICILE INFECTION; COHORT ANALYSIS; COLON RESECTION; CROHN DISEASE; DEATH; DISEASE SEVERITY; DRUG EFFICACY; DRUG EXPOSURE; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPLASIA; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HEADACHE; HEALTH SURVEY; HOSPITALIZATION; HUMAN; ILEOSTOMY; ILEUM RESECTION; INJECTION SITE REACTION; LATENT TUBERCULOSIS; LYMPHOMA; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEOPLASM; OUTCOME ASSESSMENT; PERIANAL ABSCESS; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUESTIONNAIRE; REMISSION; SIDE EFFECT; SKIN INFECTION; SWITZERLAND; TREATMENT DURATION; TREATMENT RESPONSE; TUBERCULOSIS; URINARY TRACT INFECTION;

ADULT; AGED; COHORT STUDIES; CROHN DISEASE; FEMALE; FOLLOW-UP STUDIES; GASTROENTEROLOGY; HUMANS; IMMUNOGLOBULIN FAB FRAGMENTS; MALE; MIDDLE AGED; PHYSICIANS; POLYETHYLENE GLYCOLS; PRACTICE GUIDELINES AS TOPIC; PROSPECTIVE STUDIES; QUESTIONNAIRES; REMISSION INDUCTION; SURVIVAL RATE; SWITZERLAND; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA; YOUNG ADULT;

EID: 79958810681     PISSN: 10780998     EISSN: 15364844     Source Type: Journal    
DOI: 10.1002/ibd.21521     Document Type: Article

References (39)

1. Satsangi J, Morecroft J, Shah NB, et al. Genetics of inflammatory bowel disease: scientific and clinical implications. Best Pract Res Clin Gastroenterol. 2003; 17: 3-18.
2. Blumberg RS, Saubermann LJ, Strober W., Animal models of mucosal inflammation and their relation to human inflammatory bowel disease. Curr Opin Immunol. 1999; 11: 648-656.
3. Beutler B, Greenwald D, Hulmes JD, et al. Identity of tumour necrosis factor and the macrophage-secreted factor cachectin. Nature. 1985; 316: 552-554. (Pubitemid 16239366)
4. Old LJ., Tumour necrosis factor (TNF). Science. 1985; 230: 630-633.
5. Van Deventer SJ., Tumour necrosis factor and Crohn's disease. Gut. 1997; 40: 443-448. (Pubitemid 27204920)
6. Derkx B, Taminiau J, Radema S, et al. Tumour-necrosis-factor antibody treatment in Crohn's disease. Lancet. 1993; 342: 173-174. (Pubitemid 23200450)
7. Ricciardelli I, Lindley KJ, Londei M, et al. Anti-tumor necrosis factor alpha therapy increases the number of FOXP3 regulatory T cells in children affected by Crohn's disease. Immunology. 2008; 125: 178-183.
8. 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: 1029-1035.
9. Present DH, Rutgeerts P, Targan S, et al. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999; 340: 1398-1405. (Pubitemid 29205403)
10. Rutgeerts P, D'Haens G, Targan S, et al. Efficacy and safety of retreatment with anti-tumor necrosis factor antibody (infliximab) to maintain remission in Crohn's disease. Gastroenterology. 1999; 117: 761-769. (Pubitemid 29468216)
11. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002; 359: 1541-1549. (Pubitemid 34621118)
12. 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: 323-333.
13. Sandborn WJ, Hanauer SB, Rutgeerts P, et al. Adalimumab for maintenance of Crohn's disease: results of the CLASSIC II trial. Gut. 2007; 56: 1232-1239. (Pubitemid 47300424)
14. 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. (Pubitemid 46108762)
15. Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for Crohn's disease previously treated with infliximab: a randomised trial. Ann Intern Med. 2007; 146: 829-838. (Pubitemid 351650483)
16. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007; 357: 228-238. (Pubitemid 47080387)
17. Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007; 357: 239-250. (Pubitemid 47080388)
18. Lichtenstein GR, Thomsen OO, Schreiber S, et al. Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months. Clin Gastroenterol Hepatol. 2010; 8: 600-609.
19. Schoepfer AM, Vavricka SR, Binek J, et al. Efficacy and safety of Certolizumab pegol induction therapy in an unselected Crohn's disease population: results of the FACTS survey. Inflamm Bowel Dis. 2010; 16: 933-938.
20. Pittet V, Juillerat P, Mottet C, et al. Cohort profile: the Swiss Inflammatory Bowel Disease Cohort Study (SIBDCS). Int J Epidemiol. 2008; 38: 922-931.
21. Harvey RF, Bradshaw MJ,. A simple index of Crohn's disease activity. Lancet. 1980; 1: 514.
22. Harvey RF, Bradshaw MJ., Measuring Crohn's disease activity. Lancet. 1980; 1: 1134-1135.
23. Best WR., Predicting the Crohn's disease activity index from the Harvey-Bradshaw index. Inflamm Bowel Dis. 2006; 12: 304-310.
24. Stange EF, Travis SPL, Vermeire S, et al. European evidence based consensus on the diagnosis and management of Crohn's disease: definitions and diagnosis. Gut. 2006; 55: 1-15.
25. Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010; 362: 1383-1395.
26. Adverse reaction definition. Available at, January 2002. accessed December 27th 2009.
27. World Health Organization causality assessment method. Available at, January 2002. accessed December 27th 2009.
28. Nikolaus S, Schreiber S., Review article: diagnostics of inflammatory bowel disease. Gastroenterology. 2007; 133: 1670-1689. (Pubitemid 350029755)
29. Silverberg MS, Satsangi J, Ahmad T, et al. Toward an integrated clinical, molecular and serological classification of inflammatory bowel disease: Report of a Working Party of the 2005 Montreal World Congress of Gastroenterology. Can J Gastroenterol. 2005; 19 (suppl A): 5-36.
30. Satsangi J, Silverberg MS, Vermeire S, et al. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut. 2006; 55: 749-753. (Pubitemid 43764536)
31. Bell SJ, Williams AB, Wiesel P, et al. The clinical course of fistulating Crohn's disease. Aliment Pharmacol Ther. 2003; 17: 1145-1151. (Pubitemid 36605751)
32. Present DH, Rutgeerts P, Targan S, et al. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999; 340: 1398-1405. (Pubitemid 29205403)
33. 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.
34. Parsi MA, Achkar JP, Richardson S, et al. Predictors of response to infliximab in patients with Crohn's disease. Gastroenterology. 2002; 123: 707-713. (Pubitemid 34977076)
35. Orlando A, Colombo E, Kohn A, et al. Infliximab in the treatment of Crohn's disease: predictors of response in an Italian multicentric open study. Dig Liver Dis. 2005; 37: 559-563.
36. Danese S, Stefanelli T, Omodei P, et al. Successful treatment of fistulizing Crohn's disease with certolizumab pegol. Inflamm Bowel Dis. 2008; 14: 292-293. (Pubitemid 351288054)
37. Schreiber S, Lawranc I, Thomsen O, et al. CIMZIA (certolizumab pegol) is effective in the treatment of Crohn's disease patients with open fistulas. Inflamm Bowel Dis. 2008;(suppl 3):p S1 (abstract).
38. 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.
39. 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: 644-653. (Pubitemid 351783447)