Clinical investigation in highly disease-affected rheumatoid arthritis patients in Japan with adalimumab applying standard and general evaluation: The CHANGE study

Modern Rheumatology

Volumn 18, Issue 3, 2008, Pages 252-262

  Miyasaka, Nobuyuki ^a  

^a TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

Author keywords

Adalimumab; Japanese; Pharmacokinetics; Rheumatoid arthritis; Tumor necrosis factor (TNF) antagonist

Indexed keywords

ADALIMUMAB; BUCILLAMINE; DICLOFENAC; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ISONIAZID; METHOTREXATE; PLACEBO; PREDNISOLONE; SALAZOSULFAPYRIDINE; TRIAMCINOLONE;

ADULT; ARTICLE; CLINICAL EVALUATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HUMAN; IMMUNOPATHOLOGY; INFECTION; INJECTION SITE ERYTHEMA; INJECTION SITE REACTION; JAPAN; JAPANESE; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MONOTHERAPY; MULTICENTER STUDY; OPPORTUNISTIC INFECTION; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REPEATED DRUG DOSE; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SIDE EFFECT; STATISTICAL SIGNIFICANCE; TUBERCULOSIS;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; JAPAN; MALE; MIDDLE AGED; PLACEBOS; RHEUMATOID FACTOR; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 46549084098     PISSN: 14397595     EISSN: 14397609     Source Type: Journal    
DOI: 10.1007/s10165-008-0045-0     Document Type: Article

References (19)

1. Kvien TK. Epidemiology and burden of illness of rheumatoid arthritis. Pharmacoeconomics. 2004;22 Suppl 1:1-12.
2. Miyasaka N, Takeuchi T, Eguchi K. Official Japanese guidelines for the use of infliximab for rheumatoid arthritis. Mod Rheumatol. 2005;15:4-8.
3. Shiokawa Y. International conference for the bone and joint decade. Rheumatic diseases at the dawn of the millennium. J Rheumatol. 2003;30 Suppl 67:1-2.
4. Mugitani M. International conference for the bone and joint decade. Bone and joint diseases around the world. Japan: Strategy for rheumatic disease control. J Rheumatol. 2003;30 Suppl 67:47.
5. Hakoda M, Oiwa H, Kasagi F, Masunari N, Yamada M, Suzuki G, et al. Mortality of rheumatoid arthritis in Japan: A longitudinal cohort study. Ann Rheum Dis. 2005;64:1451-5.
6. Elliott MJ, Maini RN, Feldmann M, Kalden JR, Antoni C, Smolen JS, et al. Randomised double-blind comparison of chimeric monoclonal antibody to tumour necrosis factor alpha (cA2) versus placebo in rheumatoid arthritis. Lancet 1994;344:1105-10.
7. Moreland LW, Baumgartner SW, Schiff MH, Tindall EA, Fleischmann RM, Weaver AL, et al. Treatment of rheumatoid arthritis with a recombinant human tumor necrosis factor receptor (p75)-Fc fusion protein. N Engl J Med. 1997;337:141-7.
8. Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate. Arthritis Rheum. 2003;48:35-45.
9. Abe T, Takeuchi T, Miyasaka N, Hashimoto H, Kondo H, Ichikawa Y, et al. A multicenter, double-blind, randomized, placebo controlled trial of infliximab combined with low dose methotrexate in Japanese patients with rheumatoid arthritis. J Rheumatol. 2006;33:37-44.
10. Yamanaka H, Tanaka Y, Sekiguchi N, Inoue E, Saito K, Kameda H, et al. Retrospective clinical study on the notable efficacy and related factors of infliximab therapy in a rheumatoid arthritis management group in Japan (RECONFIRM). Mod Rheumatol. 2007;17:28-32.
11. Miyasaka N, Takeuchi T, Eguchi K. Guidelines for the proper use of etanercept in Japan. Mod Rheumatol. 2006;16:63-7.
12. Prescribing Information, Humira. Abbott Laboratories, North Chicago, IL. Feb, 2007.
13. Furst DE, Schiff MH, Fleischmann RM, Strand V, Birbara CA, Compagnone D, et al. Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: Results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis). J Rheumatol. 2003;30:2563-71.
14. Van de Putte LBA, Atkins C, Malaise M, Sany J, Russell AS, van Riel PLCM, et al. Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Ann Rheum Dis. 2004;63:508-16.
15. Kashiwazaki S, Ichikawa Y, Sugawara S, et al. Determination of the clinical optimal dose of L-377 (methotrexate capsule) for the treatment of rheumatoid arthritis (in Japanese). Jpn J Inflamm. 1996;16:437-58.
16. Maini R, St. Clair EW, Breedveld F, Furst D, Kalden J, Weisman M, et al. Infliximab (chimeric anti-tumor necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: A randomized phase II trial. ATTRACT Study Group. Lancet. 1999;354:1932-9.
17. Burmester GR, Mariette X, Montecucco C, Monteagudo-Sáez I, Malaise M, Tzioufas AG, et al. Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: The research in active rheumatoid arthritis (ReAct) trial. Ann Rheum Dis. 2007;66:732-9.
18. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al. The PREMIER study: A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54:26-37.
19. Schiff MH, Burmester GR, Kent JD, Pangan AL, Kupper H, Fitzpatrick SB, et al. Safety analyses of adalimumab (HUMIRA ®) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. Ann Rheum Dis. 2006;65:889-94.