Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis

Modern Rheumatology

Volumn 21, Issue 4, 2011, Pages 343-351

  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 SCHOOL OF MEDICINE   (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

DAS28; Etanercept; Postmarketing surveillance study; Rheumatoid arthritis

Indexed keywords

ANTIRHEUMATIC AGENT; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; GLUCOCORTICOID; INFLIXIMAB; METHOTREXATE;

ADULT; ARTICLE; BACTERIAL ARTHRITIS; BRONCHITIS; CANDIDURIA; CONGESTIVE HEART FAILURE; DEMYELINATING DISEASE; DISEASE ACTIVITY; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ERYTHEMA; FEMALE; FEVER; HERPES ZOSTER; HUMAN; INFECTION RISK; INJECTION SITE REACTION; INTERSTITIAL LUNG DISEASE; JAPANESE; LIVER FUNCTION; LUPUS LIKE SYNDROME; MAJOR CLINICAL STUDY; MALE; NEOPLASM; OBSERVATIONAL STUDY; PATIENT COMPLIANCE; PNEUMOCYSTIS PNEUMONIA; PNEUMONIA; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PRURITUS; RASH; REMISSION; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SEPSIS; SIDE EFFECT; TREATMENT OUTCOME; TUBERCULOSIS; UPPER RESPIRATORY TRACT INFECTION;

ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DRUG HYPERSENSITIVITY; EXANTHEMA; FEMALE; HUMANS; IMMUNOGLOBULIN G; JAPAN; LUNG DISEASES; MALE; MIDDLE AGED; PRODUCT SURVEILLANCE, POSTMARKETING; RECEPTORS, TUMOR NECROSIS FACTOR; RISK FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 83255188765     PISSN: 14397595     EISSN: 14397609     Source Type: Journal    
DOI: 10.1007/s10165-010-0406-3     Document Type: Article

References (27)

1. Drossaers-Bakker KW, de Buck M, van Zeben D, Zwinderman AH, Breedveld FC, Hazes JM. Long-term course and outcome of functional capacity in rheumatoid arthritis: the effect of disease activity and radiologic damage over time. Arthritis Rheum. 1999;42(9):1854-60. (Pubitemid 30257749)
2. Pincus T, Sokka T, Wolfe F. Premature mortality in patients with rheumatoid arthritis: evolving concepts. Arthritis Rheum. 2001;44(6):1234-6. (Pubitemid 32537519)
3. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum. 2002;46(2): 328-46.
4. Smolen JS, Aletaha D. What should be our treatment goal in rheumatoid arthritis today? Clin Exp Rheumatol. 2006;24(6 suppl 43): S-7-13.
5. Combe B, Landewe R, Lukas C, Bolosiu HD, Breedveld F, Dougados M, et al. 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. 2007;66(1):34-45. (Pubitemid 46044858)
6. Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995;38(1):44-8.
7. Emery P, Breedveld FC, Hall S, Durez P, Chang DJ, Robertson D, et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, doubleblind, parallel treatment trial. Lancet. 2008;372(9636):375- 82.
8. 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(1):26-37. (Pubitemid 43122183)
9. van de Putte LB, Atkins C, Malaise M, Sany J, Russell AS, van Riel PL, 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(5):508-16. (Pubitemid 38530193)
10. van Riel PL, Taggart AJ, Sany J, Gaubitz M, Nab HW, Pedersen R, et al. 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. 2006;65(11):1478-83. (Pubitemid 44629126)
11. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, van Zeben D, Kerstens PJ, Hazes JM, et al. Comparison of treatment strategies in early rheumatoid arthritis: a randomized trial. Ann Intern Med. 2007;146(6):406-15. (Pubitemid 351650575)
12. van der Bijl AE, Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Ten Wolde S, Han KH, van Krugten MV, et al. Infliximab and methotrexate as induction therapy in patients with early rheumatoid arthritis. Arthritis Rheum. 2007;56(7):2129-34. (Pubitemid 47173559)
13. Moreland LW, Schiff MH, Baumgartner SW, Tindall EA, Fleischmann RM, Bulpitt KJ, et al. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Intern Med. 1999;130(6):478-86. (Pubitemid 29135800)
14. Weinblatt ME, Kremer JM, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Fox RI, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med. 1999;340(4):253-9. (Pubitemid 29063266)
15. Genovese MC, Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum. 2002;46(6):1443-50. (Pubitemid 34620189)
16. Klareskog L, van der Heijde D, de Jager JP, Gough A, Kalden J, Malaise M, et al. 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. 2004;363(9410):675-81. (Pubitemid 38296553)
17. Koike T, Harigai M, Inokuma S, Inoue K, Ishiguro N, Ryu J, et al. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol. 2009;36(5):898-906.
18. Miyasaka N, Takeuchi T, Eguchi K. Guidelines for the proper use of etanercept in Japan. Mod Rheumatol. 2006;16(2):63-7.
19. Steinbrocker O, Traeger C, Batterman R. Therapeutic criteria for rheumatoid arthritis. JAMA. 1949;140:659-62.
20. Medical Dictionary forRegulatoryActivities (MedDRA)Version 7.0. http://www.meddramsso.com/ (2007). Accessed 29 March 2010.
21. ICH Tripartite Harmonised Guideline. Clinical safety data management: definitions and standards for expedited reporting. http://www.pmda.go.jp/ich/e/ e2a-95-3-20e.pdf (1994). Accessed 3 December 2009.
22. van Gestel AM, Prevoo ML, van 't Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/ International League Against Rheumatism Criteria. Arthritis Rheum. 1996;39(1):34-40. (Pubitemid 26036375)
23. Feltelius N, Fored CM, Blomqvist P, Bertilsson L, Geborek P, Jacobsson LT, et al. Results from a nationwide postmarketing cohort study of patients in Sweden treated with etanercept. Ann Rheum Dis. 2005;64(2):246-52. (Pubitemid 40193621)
24. 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(7):889-94.
25. Takeuchi T, Tatsuki Y, Nogami Y, Ishiguro N, Tanaka Y, Yamanaka H, et al. Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis. 2008;67(2):189-94. (Pubitemid 351183307)
26. Weaver AL, Lautzenheiser RL, Schiff MH, Gibofsky A, Perruquet JL, Luetkemeyer J, et al. Real-world effectiveness of select biologic and DMARD monotherapy and combination therapy in the treatment of rheumatoid arthritis: results from the RADIUS observational registry. Curr Med Res Opin. 2006;22(1):185-98. (Pubitemid 43106921)
27. Gibofsky A, Palmer WR, Goldman JA, Lautzenheiser RL, Markenson JA, Weaver A, et al. Real-world utilization of DMARDs and biologics in rheumatoid arthritis: the RADIUS (Rheumatoid Arthritis Disease-Modifying Anti-Rheumatic Drug Intervention and Utilization Study) study. Curr Med Res Opin. 2006;22(1):169-83. (Pubitemid 43106920)