Safety and effectiveness responses to etanercept for rheumatoid arthritis in Japan: A sub-analysis of a post-marketing surveillance study focusing on the duration of rheumatoid arthritis

Rheumatology International

Volumn 32, Issue 6, 2012, Pages 1511-1519

  Koike, Takao ^a   Harigai, Masayoshi ^b   Inokuma, Shigeko ^c   Ishiguro, Naoki ^d   Ryu, Junnosuke ^e   Takeuchi, Tsutomu ^f   Tanaka, Yoshiya ^g   Yamanaka, Hisashi ^h   Fujii, Koichi ⁱ   Yoshinaga, Takunari ⁱ   Freundlich, Bruce ^j   Suzukawa, Michio ⁱ  

^a HOKKAIDO UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

^c JAPANESE RED CROSS MEDICAL CENTER   (Japan)

^d NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^e NIHON UNIVERSITY   (Japan)

^f KEIO UNIVERSITY   (Japan)

^g UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

^h TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

ⁱ PFIZER INC   (United States)

^j UNIVERSITY OF PENNSYLVANIA   (United States)

more..

Author keywords

Antirheumatic agents adverse effects; Antirheumatic agents therapeutic use; Arthritis; Japan; Postmarketing statistics numerical data; Product surveillance; Receptors; Rheumatoid drug therapy; Tumor necrosis factor therapeutic use

Indexed keywords

ACTARIT; AURANOFIN; AZATHIOPRINE; BUCILLAMINE; CORTICOSTEROID; CYCLOPHOSPHAMIDE; CYCLOSPORIN; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; INFLIXIMAB; LEFLUNOMIDE; LOBENZARIT; METHOTREXATE; MINOCYCLINE; MIZORIBINE; PENICILLAMINE; SALAZOSULFAPYRIDINE; SODIUM AUROTHIOSULFATE; TACROLIMUS;

ADULT; ALLERGY; ARTICLE; COMORBIDITY; CORTICOSTEROID THERAPY; DISEASE CONTROL; DISEASE COURSE; DISEASE DURATION; DISEASE SEVERITY; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; FEMALE; HUMAN; INFECTION; JAPAN; JOINT DESTRUCTION; MAJOR CLINICAL STUDY; MALE; MUSCULOSKELETAL STIFFNESS; NEOPLASM; PHYSICAL CAPACITY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; REMISSION; RHEUMATOID ARTHRITIS; SMOKING HABIT; TREATMENT DURATION;

ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; ASIAN CONTINENTAL ANCESTRY GROUP; CHI-SQUARE DISTRIBUTION; DRUG SUBSTITUTION; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; IMMUNOGLOBULIN G; JAPAN; LOGISTIC MODELS; MALE; MIDDLE AGED; ODDS RATIO; PRODUCT SURVEILLANCE, POSTMARKETING; PROPORTIONAL HAZARDS MODELS; RECEPTORS, TUMOR NECROSIS FACTOR; RISK ASSESSMENT; RISK FACTORS; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME;

EID: 84863869931     PISSN: 01728172     EISSN: 1437160X     Source Type: Journal    
DOI: 10.1007/s00296-010-1784-8     Document Type: Article

References (30)

1. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines (2002) Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum 46:328-346
2. Luqmani R, Hennell S, Estrach C, Birrell F, Bosworth A, Davenport G, Fokke C, Goodson N, Jeffreson P, Lamb E, Mohammed R, Oliver S, Stableford Z, Walsh D, Washbrook C, Webb F (2006) British Society for Rheumatology and british health professionals in Rheumatology guideline for the management of rheumatoid arthritis (the first two years). Rheumatology (Oxford) 45:1167-1169
3. Combe B, Landewe R, Lukas C, Bolosiu HD, Breedveld F, Dougados M, Emery P, Ferraccioli G, Hazes JM, Klareskog L, Machold K, Martin-Mola E, Nielsen H, Silman A, Smolen J, Yazici H (2007) EULAR recommendations for the management of early arthritis: report of a task force of the European Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 66:34-45
4. Benhamou M, Rincheval N, Roy C, Foltz V, Rozenberg S, Sibilia J, Schaeverbeke T, Bourgeois P, Ravaud P, Fautrel B (2009) The gap between practice and guidelines in the choice of first-line disease modifying antirheumatic drug in early rheumatoid arthritis: results from the ESPOIR cohort. J Rheumatol 36:934-942
5. Kiely P, Williams R, Walsh D, Young A (2009) Contemporary patterns of care and disease activity outcome in early rheumatoid arthritis: the ERAN cohort. Rheumatology (Oxford) 48:57-60
6. Alonso-Ruiz A, Pijoan JI, Ansuategui E, Urkaregi A, Calabozo M, Quintana A (2008) Tumor necrosis factor alpha drugs in rheumatoid arthritis: systematic review and metaanalysis of efficacy and safety. BMC Musculoskelet Disord 9:52
7. Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, Genovese MC, Wasko MC, Moreland LW, Weaver AL, Markenson J, Finck BK (2000) A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 343:1586-1593
8. Dhillon S, Lyseng-Williamson KA, Scott LJ (2007) Etanercept: a review of its use in the management of rheumatoid arthritis. Drugs 67:1211-1241
9. Klareskog L, van der Heijde D, De Jager JP, Gough A, Kalden J, Malaise M, Martin ME, Pavelka K, Sany J, Settas L, Wajdula J, Pedersen R, Fatenejad S, Sanda M (2004) Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet 363:675-681
10. van der Heijde D, Klareskog L, Singh A, Tornero J, Melo-Gomes J, Codreanu C, Pedersen R, Freundlich B, Fatenejad S (2006) Patient reported outcomes in a trial of combination therapy with etanercept and methotrexate for rheumatoid arthritis: the TEMPO trial. Ann Rheum Dis 65:328-334
11. Keystone EC, Schiff MH, Kremer JM, Kafka S, Lovy M, DeVries T, Burge DJ (2004) Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 50:353-363
12. Levalampi T, Korpela M, Vuolteenaho K, Moilanen E (2008) Etanercept and adalimumab treatment in patients with rheumatoid arthritis and spondyloarthropathies in clinical practice: adverse events and other reasons leading to discontinuation of the treatment. Rheumatol Int 28:261-269
13. van Riel PL, Taggart AJ, Sany J, Gaubitz M, Nab HW, Pedersen R, Freundlich B, Macpeek D (2006) Efficacy and safety of combination etanercept and methotrexate versus etanercept alone in patients with rheumatoid arthritis with an inadequate response to methotrexate: the ADORE study. Ann Rheum Dis 65:1478-1483
14. Bingham CO III, Ince A, Haraoui B, Keystone EC, Chon Y, Baumgartner S (2009) Effectiveness and safety of etanercept in subjects with RA who have failed infliximab therapy: 16-week, open-label, observational study. Curr Med Res Opin 25:1131-1142
15. Hetland ML, Christensen IJ, Tarp U, Dreyer L, Hansen A, Hansen IT, Kollerup G, Linde L, Lindegaard HM, Poulsen UE, Schlemmer A, Jensen DV, Jensen S, Hostenkamp G, Ostergaard M (2010) Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry. Arthritis Rheum 62:22-32
16. Emery P, Breedveld F, van der Heijde D, Ferraccioli G, Dougados M, Robertson D, Pedersen R, Koenig AS, Freundlich B (2010) Two-year clinical and radiographic results with combination etanercept-methotrexate therapy versus monotherapy in early rheumatoid arthritis: a two-year, double-blind, randomized study. Arthritis Rheum 62:674-682
17. Emery P, Breedveld FC, Hall S, Durez P, Chang DJ, Robertson D, Singh A, Pedersen RD, Koenig AS, Freundlich B (2008) Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet 372:375-382
18. Singh JA, Christensen R, Wells GA, Suarez-Almazor ME, Buchbinder R, Lopez-Olivo MA, Ghogomu ET, Tugwell P (2009) A network meta-analysis of randomized controlled trials of biologics for rheumatoid arthritis: a Cochrane overview. CMAJ 181:787-796
19. Koike T, Harigai M, Inokuma S, Inoue K, Ishiguro N, Ryu J, Takeuchi T, Tanaka Y, Yamanaka H, Fujii K, Freundlich B, Suzukawa M (2009) Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol 36:898-906
20. Miyasaka N, Takeuchi T, Eguchi K (2006) Guidelines for the proper use of etanercept in Japan. Mod Rheumatol 16:63-67
21. Steinbrocker O, Traeger CH, Batterman RC (1949) Therapeutic criteria in rheumatoid arthritis. JAMA 140:659-662
22. Goekoop-Ruiterman YP, Vries-Bouwstra JK, Allaart CF, van Zeben D, Kerstens PJ, Hazes JM, Zwinderman AH, Ronday HK, Han KH, Westedt ML, Gerards AH, van Groenendael JH, Lems WF, van Krugten MV, Breedveld FC, Dijkmans BA (2005) Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum 52:3381-3390
23. Listing J, Strangfeld A, Kary S, Rau R, von Hinueber U, Stoyanova-Scholz M, Gromnica-Ihle E, Antoni C, Herzer P, Kekow J, Schneider M, Zink A (2005) Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum 52:3403-3412
24. Weinblatt ME, Kremer JM, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Fox RI, Jackson CG, Lange M, Burge DJ (1999) A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 340:253-259
25. 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 (1999) Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Intern Med 130:478-486
26. Baumgartner SW, Fleischmann RM, Moreland LW, Schiff MH, Markenson J, Whitmore JB (2004) Etanercept (Enbrel) in patients with rheumatoid arthritis with recent onset versus established disease: improvement in disability. J Rheumatol 31:1532-1537
27. Keystone E, Freundlich B, Schiff M, Li J, Hooper M (2009) Patients with moderate rheumatoid arthritis (RA) achieve better disease activity states with etanercept treatment than patients with severe RA. J Rheumatol 36:522-531
28. Pincus T, Callahan LF (1990) Remodeling the pyramid or remodeling the paradigms concerning rheumatoid arthritis-lessons from Hodgkin's disease and coronary artery disease. J Rheumatol 17:1582-1585
29. Wolfe F, Sharp JT (1998) Radiographic outcome of recent-onset rheumatoid arthritis: a 19-year study of radiographic progression. Arthritis Rheum 41:1571-1582
30. Rich E, Moreland LW, Alarcon GS (1999) Paucity of radiographic progression in rheumatoid arthritis treated with methotrexate as the first disease modifying antirheumatic drug. J Rheumatol 26:259-261