A Pilot Randomized Trial of a Human Anti-Interleukin-6 Receptor Monoclonal Antibody in Active Crohn's Disease

Gastroenterology

Volumn 126, Issue 4, 2004, Pages 989-996

  Ito, Hiroaki ^a   Takazoe, Masakazu ^b   Fukuda, Yoshihiro ^c   Hibi, Toshifumi ^d   Kusugami, Kazuo ^e   Andoh, Akira ^f   Matsumoto, Takayuki ^g   Yamamura, Takehira ^c   Azuma, Junichi ^h   Nishimoto, Norihiro ^h   Yoshizaki, Kazuyuki ^h   Shimoyama, Takashi ^c   Kishimoto, Tadamitsu ^h  

^a OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b Social Health Insurance Medical Center   (Japan)

^c HYOGO COLLEGE OF MEDICINE   (Japan)

^d KEIO UNIVERSITY   (Japan)

^e NAGOYA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^f SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

^g OSAKA CITY UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^h OSAKA UNIVERSITY   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

AZATHIOPRINE; CORTICOSTEROID; HUMAN MONOCLONAL ANTIBODY; INTERLEUKIN 6 RECEPTOR; MERCAPTOPURINE; MESALAZINE; METRONIDAZOLE; PLACEBO; SALAZOSULFAPYRIDINE;

ABDOMINAL PAIN; ACUTE PHASE RESPONSE; ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; COMMON COLD; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROHN DISEASE; DISEASE ACTIVITY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; ENTERITIS; FEMALE; GASTROINTESTINAL ENDOSCOPY; GASTROINTESTINAL HEMORRHAGE; HEADACHE; HISTOLOGY; HUMAN; INFLAMMATION; INSOMNIA; MALE; NAUSEA; PAIN; PARALYTIC ILEUS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REMISSION; TREATMENT OUTCOME; VOMITING;

EID: 11144358366     PISSN: 00165085     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.gastro.2004.01.012     Document Type: Article

References (21)

1. Shanahan F. Crohn's disease. Lancet 2002;359:62-69.
2. Kishimoto T. The biology of interleukin-6. Blood 1989;74:1-10.
3. Jones SA, Horiuchi S, Topley N, Yamamoto N, Fuller GM. The soluble interleukin 6 receptor: mechanisms of production and implications in disease. FASEB J 2001;15:43-58.
4. Mitsuyama K, Toyonaga A, Sasaki E, Ishida O, Ikeda H, Tsuruta O, Harada K, Tateishi H, Nishiyama T, Tanikawa K. Soluble interleukin-6 receptors in inflammatory bowel disease: relation to circulating interleukin-6. Gut 1995;36:45-49.
5. Hosokawa T, Kusugami K, Ina K, Ando T, Shinoda M, Imada A, Ohsuga M, Sakai T, Matsuura T, Ito K, Kaneshiro K. Interleukin-6 and soluble interleukin-6 receptor in the colonic mucosa of inflammatory bowel disease. J Gastroenterol Hepatol 1999;14: 987-996.
6. Yamamoto M, Yoshizaki K, Kishimoto T, Ito H. IL-6 is required for the development of Th1 cell-mediated murine colitis. J Immunol 2000;164:4878-4882.
7. Atreya R, Mudter J, Finotto S, Müllberg J, Jostock T, Wirtz S, Schütz M, Bartsch B, Holtmann M, Becker C, Strand D, Czaja J, Schlaak JF, Lehr HA, Autschbach F, Schürmann G, Nishimoto N, Yoshizaki K, Ito H, Kishimoto T, Galle PR, Rose-John S, Neurath MF. Blockade of interleukin 6 trans signaling suppresses T-cell resistance against apoptosis in chronic intestinal inflammation: evidence in Crohn disease and experimental colitis in vivo. Nat Med 2000;6:583-588.
8. Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index: National Cooperative Crohn's Disease Study. Gastroenterology 1976;70:439-444.
9. Nishimoto N, Yoshizaki K, Maeda K, Kuritani T, Deguchi H, Sato B, Imai N, Suemura M, Kakehi T, Takagi N, Kishimoto T. Toxicity, pharmacokinetics, and dose-finding study of repetitive treatment with the humanized anti-interleukin 6 receptor antibody MRA in rheumatoid arthritis. Phase 1/11 clinical study. J Rheumatol 2003; 30:1426-1435.
10. Sato K, Tsuchiya M, Saldanha J, Koishihara Y, Ohsugi Y, Kishimoto T, Bendig MM. Reshaping a human antibody to inhibit the interleukin 6-dependent tumor cell growth. Cancer Res 1993;53: 851-856.
11. Irvine EJ, Feagan B, Rochon J, Archambault A, Fedorak RN, Groll A, Kinnear D, Saibil F, McDonald JW. Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Gastroenterology 1994;106:287-296.
12. Mary JY, Modigliani R. Development and validation of an endoscopic index of the severity for Crohn's disease: a prospective multicentre study. Gut 1989;30:983-989.
13. Choy EHS, Isenberg DA, Garrood T, Farrow S, Ioannou Y, Bird H, Cheung N, Williams B, Hazleman B, Price R, Yoshizaki K, Nishimoto N, Kishimoto T, Panayi GS. Therapeutic benefit of blocking interleukin-6 activity with an anti-interleukin-6 receptor monoclonal antibody in rheumatoid arthritis. Arthritis Rheum 2002;46: 3143-3150.
14. Targan SR, Hanauer SB, van Deventer SH, Mayer L, Present DH, Braakman T, DeWoody KL, Schaible TF, Rutgeerts PJ. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor α for Crohn's disease. N Engl J Med 1997;337:1029-1035.
15. Lipsky PE, van der Heijde DM, St. Clair EW, Furst DE, Breedveld FC, Kalden JR, Smolen JS, Weisman M, Emery P, Feldmann M, Harriman GR, Maini RN. Anti-tumor necrosis factor trial in rheumatoid arthritis with concomitant therapy study group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med 2000;343:1594-1602.
16. Moreland LW, Schiff MH, Baumgartner SW, Tindall EA, Fleischmann RM, Bulpitt KJ, Weaver AL, Keystone EC, Furst DE, Mease PJ, Ruderman EM, Horwitz DA, Arkfeld DG, Garrison L, Burge DJ, Blosch CM, Lange ML, McDonnell ND, Weinblatt ME. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Intern Med 1999;130:478-486.
17. Bresnihan B, Alvaro-Gracia JM, Cobby M, Doherty M, Domljan Z, Emery P, Nuki G, Pavelka K, Rau R, Rozman B, Watt I, Williams B, Aitchison R, McCabe D, Musikic P. Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist. Arthritis Rheum 1998;41:2196-2204.
18. Jones SA, Novick D, Horiuchi S, Yamamoto N, Szalai AJ, Fuller GM. C-reactive protein: a physiological activator of interleukin 6 receptor shedding. J Exp Med 1999;189:599-604.
19. D'Haens G, Van Deventer S, Van Hogezand R, Chalmers D, Kothe C, Baert F, Braakman T, Schaible T, Geboes K, Rutgeerts P. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: a European multicenter trial. Gastroenterology 1999;116:1029-1034.
20. Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P, and the ACCENT I study group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002; 359:1541-1549.
21. Jacob CO, McDevitt HO. Tumour necrosis factor-alpha in murine autoimmune "lupus" nephritis. Nature 1988;331:356-358.