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

Alimentary Pharmacology and Therapeutics

Volumn 20, Issue 11-12, 2004, Pages 1337-1346

  Winter, T A ^a   Wright, J ^b   Ghosh, S ^c   Jahnsen, J ^d   Innes, A ^e   Round, P ^e  

^a UNIVERSITY OF KENTUCKY   (United States)

^b Kingsbury Hospital   (South Africa)

^c HAMMERSMITH HOSPITAL   (United Kingdom)

^d AKER UNIVERSITY HOSPITAL   (Norway)

^e UCB PHARMA   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

AZATHIOPRINE; CERTOLIZUMAB PEGOL; CORTICOSTEROID; IMMUNOGLOBULIN F(AB) FRAGMENT; MERCAPTOPURINE; MESALAZINE; METHOTREXATE; OLSALAZINE; SALAZOSULFAPYRIDINE; TUMOR NECROSIS FACTOR ANTIBODY;

ABDOMINAL PAIN; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROHN DISEASE; DISEASE ACTIVITY; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEVER; HEADACHE; HUMAN; LUPUS ERYTHEMATOSUS; MAJOR CLINICAL STUDY; MALE; OPPORTUNISTIC INFECTION; PERIANAL ABSCESS; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REMISSION; RHINOPHARYNGITIS; TREATMENT OUTCOME; TUBERCULOSIS; URINARY TRACT INFECTION;

ADOLESCENT; ADULT; AGED; ANTI-INFLAMMATORY AGENTS; CROHN DISEASE; HUMANS; INFUSIONS, INTRAVENOUS; MIDDLE AGED; POLYETHYLENE GLYCOLS; TREATMENT OUTCOME;

EID: 11144318616     PISSN: 02692813     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2004.02285.x     Document Type: Article

References (22)

1. Podolsky DK. Inflammatory bowel disease. N Engl J Med 2002; 347: 417-29.
2. Rampton DS. Management of Crohn's disease. BMJ 1999; 319: 1480-5.
3. Hanauer S, Sandborn W. Management of Crohn's disease in adults. Am J Gastroenterol 2001; 96: 635-43.
4. van Deventer SJ. Tumour necrosis factor and Crohn's disease. Gut 1997; 40: 443-8.
5. Maini RN, St Clair EW, Breedveld FC, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) vs. placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. Lancet 1999; 354: 1932-9.
6. Moreland LW, Schiff MH, Baumgartner SW, et al. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Intern Med 1999; 130: 478-86.
7. Choy EH, Hazleman B, Smith M, et al. Efficacy of a novel humanized anti-TNF fragment (CDP870) in patients with rheumatoid arthritis: a phase II double-blinded, randomised, dose-escalating trial. Rheumatology 2002; 42: 1133-7.
8. Stack WA, Mann SD, Roy AJ, et al. Randomised controlled trial of CDP571 antibody to tumour necrosis factor-α in Crohn's disease. Lancet 1997; 349: 521-4.
9. Targan SR, Hanauer SB, van Deventer SJH, et al. A short-term study of chimeric monoclonal antibody cA2 to tumour necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. N Engl J Med 1997; 337: 1029-35.
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: 761-9.
11. 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.
12. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002; 359: 1541-9.
13. Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med 2003; 348: 601-8.
14. Farrell RJ, Alsahli M, Jeen YT, Falchuk KR, Peppercorn MA, Michetti P. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial. Gastroenterology 2003; 124: 917-24.
15. Sandborn WJ. Preventing antibodies to infliximab in patients with Crohn's disease: optimize not immunize. Gastroenterology 2003; 124: 1140-5.
16. van Deventer SJ. New biological therapies in inflammatory bowel disease. Best Pract Res Clin Gastroenterol 2003; 17: 119-30.
17. Schreiber S, Rutgeerts P, Fedorak R, et al. CDP870, a Humanized anti-TNF Antibody Fragment, Induces Clinical Response with Remission in Patients with Active Crohn's Disease (CD). Orlando, FL, USA: Digestive Disease Week/American Gastroenterology Association, 2003 (Abstract 468).
18. Keystone E, Choy EH, Kalden J, et al. CDP870, a Novel, Pegylated, Humanized TNF-α Inhibitor is Effective in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA). Abstract presented at the American College of Rheumatology 64th Annual Scientific Meeting, San Francisco, CA, USA: American College of Rheumatology, 2001.
19. Su C, Lichtenstein GR, Krok K, Brensinger CM, Lewis JD. A meta-analysis of the placebo rates of remission and response in clinical trials of active Crohn's disease. Gastroenterology 2004; 126: 1257-69.
20. Yacyshyn BR, Chey WY, Goff J, et al. Double blind placebo controlled trial of the remission inducing and steroid sparing properties of an ICAM-1 antisense oligodeoxynucleotide, alicaforsen (ISIS 2302), in active steroid dependent Crohn's disease. Gut 2002; 51: 30-6.
21. Lichtenstein GR, Olson A, Bao W, Travers S, Diamond RH. Infliximab treatment does not result in an increased risk of intestinal strictures or obstruction in Crohn's disease patients. Am J Gastroenterol 2002; 97: S254.
22. Hanauer SB. Review article: Safety of infliximab in clinical trials. Aliment Pharmacol Ther 1999; 13 (Suppl. 4): 16-22.