Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease

Journal of Crohn's and Colitis

Volumn 6, Issue 2, 2012, Pages 160-173

  Watanabe, Mamoru ^a   Hibi, Toshifumi ^b   Lomax, Kathleen G ^c   Paulson, Susan K ^c   Chao, Jingdong ^c   Alam, M Shamsul ^d   Camez, Anne ^e  

^a TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

^b KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^c ABBOTT LABORATORIES   (United States)

^d Abbott GmbH and Co KG ^*

^e ABBOTT GMBH AND CO KG   (Germany)

Author keywords

Adalimumab; Crohn's disease; Double blind trials; Induction; Japan; Maintenance

Indexed keywords

ADALIMUMAB; C REACTIVE PROTEIN; TUMOR NECROSIS FACTOR ANTIBODY;

ABDOMINAL ABSCESS; ADULT; ARTICLE; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; CROHN DISEASE; DEMYELINATING DISEASE; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HUMAN; IMMUNOGENICITY; INFECTION; INJECTION SITE PAIN; JAPANESE; LIVER ABSCESS; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; REMISSION; TREATMENT DURATION; TREATMENT OUTCOME; TUBERCULOSIS;

ADULT; ANTI-INFLAMMATORY AGENTS; ANTIBODIES, MONOCLONAL, HUMANIZED; ASIAN CONTINENTAL ANCESTRY GROUP; C-REACTIVE PROTEIN; CROHN DISEASE; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INDUCTION CHEMOTHERAPY; JAPAN; MAINTENANCE CHEMOTHERAPY; MALE; QUALITY OF LIFE; REMISSION INDUCTION; TUMOR NECROSIS FACTOR-ALPHA; YOUNG ADULT;

EID: 84856715088     PISSN: 18739946     EISSN: 18764479     Source Type: Journal    
DOI: 10.1016/j.crohns.2011.07.013     Document Type: Article

References (20)

1. Mizushima T., Ohno Y., Nakajima K., Kai Y., Iijima H., Sekimoto M., Nishida T., Nezu R., Ito T., Doki Y., Mori M. Malignancy in Crohn's disease: incidence and clinical characteristics in Japan. Digestion 2010, 81:265-270.
2. Asakura H., Yao T., Matsui T., Koganei K., Fukushima T., Takazoe M., Hobara R., Nakano H., Okamura S., Matsueda K., Kashida H., Makiyama K., Hiwatashi N., Kashiwagi K., Hibi T. Efficacy of treatment with chimeric monoclonal antibody (infliximab) to tumor necrosis factor-alpha for Crohn's disease in Japan: evaluation by rapid turnover proteins, and radiologic and endoscopic findings. J Gastroenterol Hepatol 2001, 16:763-769.
3. HUMIRA Prescribing information 2009, Abbott Laboratories, Abbott Park, IL.
4. Colombel J.F., Sandborn W.J., Rutgeerts P., Enns R., Hanauer S.B., Panaccione R., Schreiber S., Byczkowski D., Li J., Kent J.D., Pollack P.F. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007, 132:52-65.
5. Sandborn W.J., Rutgeerts P., Enns R., Hanauer S.B., Colombel J.F., Panaccione R., D'Haens G., Li J., Rosenfeld M.R., Kent J.D., Pollack P.F. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med 2007, 146:829-838.
6. Papadakis K.A. Crohn's disease: adalimumab improves quality of life. Nat Rev Gastroenterol Hepatol 2009, 6:200-201.
7. Loftus E.V., Feagan B.G., Colombel J.F., Rubin D.T., Wu E.Q., Yu A.P., Pollack P.F., Chao J., Mulani P. Effects of adalimumab maintenance therapy on health-related quality of life of patients with Crohn's disease: patient-reported outcomes of the CHARM trial. Am J Gastroenterol 2008, 103:3132-3141.
8. Ng S.C., Plamondon S., Gupta A., Burling D., Kamm M.A. Prospective assessment of the effect on quality of life of anti-tumour necrosis factor therapy for perineal Crohn's fistulas. Aliment Pharmacol Ther 2009, 30:757-766.
9. Colombel J.F., Sandborn W.J., Rutgeerts P., Kamm M.A., Yu A.P., Wu E.Q., Pollack P.F., Lomax K.G., Chao J., Mulani P.M. Comparison of two adalimumab treatment schedule strategies for moderate-to-severe Crohn's disease: results from the CHARM trial. Am J Gastroenterol 2009, 104:1170-1179.
10. Sugiyama Y. The Journal of the Japanese Society of Internal Medicine. Intern Med 2000, 89:868-873.
11. Myren J., Bouchier I., Watkinson G., Softley A., Clamp S., de Dombal F. The O.M.G.E. multinational inflammatory bowel disease survey 1976-1982: a further report on 2657 cases. Scan J Gastro 1983, 18:1-27.
12. Fukuhara S., Bito S., Green J., Hsiao A., Kurokawa K. Translation, adaptation, and validation of the SF-36 Health Survey for use in Japan. J Clin Epidemiol 1998, 51:1037-1044.
13. Fukuhara S., Ware J.E., Kosinski M., Wada S., Gandek B. Psychometric and clinical tests of validity of the Japanese SF-36 Health Survey. J Clin Epidemiol 1998, 51:1045-1053.
14. Hashimoto H., Green J., Iwao Y., Sakurai T., Hibi T., Fukuhara S. Reliability, validity, and responsiveness of the Japanese version of the Inflammatory Bowel Disease Questionnaire. J Gastroenterol 2003, 38:1138-1143.
15. Weisman M.H., Moreland L.W., Furst D.E., Weinblatt M.E., Keystone E.C., Paulus H.E., Teoh L.S., Velagapudi R.B., Noertersheuser P.A., Granneman G.R., Fischkoff S.A., Chartash E.K. Efficacy, pharmacokinetic, and safety assessment of adalimumab, a fully human anti-tumor necrosis factor-alpha monoclonal antibody, in adults with rheumatoid arthritis receiving concomitant methotrexate: a pilot study. Clin Ther 2003, 25:1700-1721.
16. Hanauer S.B., Sandborn W.J., Rutgeerts P., Fedorak R.N., Lukas M., MacIntosh D., Panaccione R., Wolf D., Pollack P. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology 2006, 130:323-333. quiz 591.
17. Sandborn W.J., Colombel J.F., Schreiber S., Plevy S.E., Pollack P.F., Robinson A.M., Chao J., Mulani P. Dosage adjustment during long-term adalimumab treatment for Crohn's disease: clinical efficacy and pharmacoeconomics. Inflamm Bowel Dis 2010, [published online ahead of print May 10, 2010]. 10.1002/ibd.21328.
18. Sandborn W.J., Hanauer S.B., Rutgeerts P., Fedorak R.N., Lukas M., MacIntosh D.G., Panaccione R., Wolf D., Kent J.D., Bittle B., Li L., Pollack P.F. Adalimumab for maintenance treatment of Crohn's disease: results of the CLASSIC II trial. Gut 2007, 56:1232-1239.
19. Miyasaka N. Clinical investigation in highly disease-affected rheumatoid arthritis patients in Japan with adalimumab applying standard and general evaluation: the CHANGE study. Mod Rheumatol 2008, 18:252-262.
20. Van Loghem E. Allotypic markers. Monogr Allergy 1986, 19:40-51.