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

Modern Rheumatology

Volumn 26, Issue 4, 2016, Pages 491-498

  Harigai, Masayoshi ^a   Ishiguro, Naoki ^b   Inokuma, Shigeko ^c   Mimori, Tsuneyo ^d   Ryu, Junnosuke ^e   Takei, Syuji ^f   Takeuchi, Tsutomu ^g   Tanaka, Yoshiya ^h   Takasaki, Yoshinari ⁱ   Yamanaka, Hisashi ^j   Watanabe, Masahiko ^k   Tamada, Hiroshi ^k   Koike, Takao ^l,m  

^a TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

^b NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^c Chiba Central Medical Center   (Japan)

^d KYOTO UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^e NIHON UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^f KAGOSHIMA UNIVERSITY   (Japan)

^g KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^h UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

ⁱ JUNTENDO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^j TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^k Bristol Myers KK   (Japan)

^l NTT CORPORATION   (Japan)

^m HOKKAIDO UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

more..

Author keywords

Abatacept; Japan; PMS; Rheumatoid arthritis; Safety

Indexed keywords

ABATACEPT; C REACTIVE PROTEIN; GLUCOCORTICOID; METHOTREXATE; PREDNISOLONE; ANTIRHEUMATIC AGENT;

ADULT; ARTICLE; BRONCHITIS; COLORECTAL CANCER; DAS28; DEATH; DISEASE DURATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEVER; FOLLOW UP; HERPES ZOSTER; HUMAN; INTERSTITIAL PNEUMONIA; JAPANESE (PEOPLE); LIVER DISEASE; LUNG TUMOR; LYMPHOCYTE COUNT; LYMPHOMA; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; OVARY CANCER; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PNEUMOCYSTIS PNEUMONIA; PNEUMONIA; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RASH; RECOMMENDED DRUG DOSE; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; RISK FACTOR; STOMACH CANCER; STOMATITIS; TREATMENT DURATION; TUBERCULOSIS; UPPER RESPIRATORY TRACT INFECTION; AGED; ARTHRITIS, RHEUMATOID; ERYTHROCYTE SEDIMENTATION RATE; JAPAN; TREATMENT OUTCOME;

ABATACEPT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BLOOD SEDIMENTATION; C-REACTIVE PROTEIN; FEMALE; HUMANS; JAPAN; MALE; MIDDLE AGED; PRODUCT SURVEILLANCE, POSTMARKETING; TREATMENT OUTCOME;

EID: 84953734825     PISSN: 14397595     EISSN: 14397609     Source Type: Journal    
DOI: 10.3109/14397595.2015.1123211     Document Type: Article

References (33)

1. A.J.Silman, M.C.Hochberg Epidemiology of the rheumatic diseases. 2nd ed. New York: Oxford University Press; 2001.
2. L.Pollard, E.H.Choy, D.L.Scott The consequences of rheumatoid arthritis: quality of life measures in the individual patient. Clin Exp Rheumatol. 2005;23:S43–52.
3. H.Yamanaka, N.Sugiyama, E.Inoue, A.Taniguchi, S.Momohara Estimates of the prevalence of and current treatment practices for rheumatoid arthritis in Japan using reimbursement data from health insurance societies and the IORRA cohort (I). Mod Rheumatol. 2014;24:33–40.
4. J.A.Singh, D.E.Furst, A.Bharat, J.R.Curtis, A.F.Kavanaugh, J.M.Kremer, et al. Update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64:625–39.
5. J.S.Smolen, R.Landewé, F.C.Breedveld, M.Buch, G.Burmester, M.Dougados, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73:492–509.
6. P.E.Lipsky, D.M.V.D.HeijdeDM van der, E.W.St Clair, D.E.Furst, F.C.Breedveld, J.R.Kalden, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-tumor necrosis factor trial in rheumatoid arthritis with Concomitant Therapy Study Group. N Engl J Med. 2000;343:1594–602.
7. P.E.Lipsky, D.M.V.D.HeijdeDM van der, E.W.St Clair, D.E.Furst, F.C.Breedveld, J.R.Kalden, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-tumor necrosis factor trial in rheumatoid arthritis with Concomitant Therapy Study Group. N Engl J Med. 2000;343:1594–602.
8. M.E.Weinblatt, J.M.Kremer, A.D.Bankhurst, K.J.Bulpitt, R.M.Fleischmann, R.I.Fox, 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;340:253–9.
9. M.E.Weinblatt, E.C.Keystone, D.E.Furst, L.W.Moreland, M.H.Weisman, C.A.Birbara, et al. Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum. 2003;48:35–45.
10. A.Finckh, J.F.Simard, C.Gabay, P.A.Guerne Evidence for differential acquired drug resistance to anti-TNF agents in rheumatoid arthritis. Ann Rheum Dis. 2008;67:746–52.
11. M.Schiff Abatacept treatment for rheumatoid arthritis. Rheumatology 2011;50:437–9.
12. J.M.Kremer, M.Dougados, P.Emery, P.Durez, J.Sibilia, W.Shergy, et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase iib, double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005;52:2263–71.
13. M.Schiff, M.Keiserman, C.Codding, S.Songcharoen, A.Berman, S.Nayiager, et al. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis. 2008;67:1096–103.
14. J.M.Kremer, H.K.Genant, L.W.Moreland, A.S.Russell, P.Emery, C.Abud-Mendoza,. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2006;144:865–76.
15. T.Takeuchi, H.Kameda The Japanese experience with biologic therapies for rheumatoid arthritis. Nat Rev Rheumatol. 2010;6:644–52.
16. M.L.Prevoo, M.A.van ’t Hof, H.H.Kuper, M.A.van Leeuwen, L.B.van de Putte, P.L.van Riel 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;38:44–8.
17. T.Koike, M.Harigai, S.Inokuma, K.Inoue, N.Ishiguro, J.Ryu, et al. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol. 2009;36:898–906.
18. T.Koike, M.Harigai, N.Ishiguro, S.Inokuma, S.Takei, T.Takeuchi, et al. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of the first 3000 patients. Mod Rheumatol. 2012;22:498–508.
19. T.A.Simon, J.Askling, D.Lacaille, J.Franklin, F.Wolfe, A.Covucci, et al. Infections requiring hospitalization in the abatacept clinical development program: an epidemiological assessment. Arthritis Res Ther. 2010;12:R67.
20. T.Takeuchi, Y.Tatsuki, Y.Nogami, N.Ishiguro, Y.Tanaka, H.Yamanaka, et al. Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis. 2008;67:189–94.
21. D.He, F.Bai, S.Zhang, T.Jiang, J.Shen, Q.Zhu, et al. High incidence of tuberculosis infection in rheumatic diseases and impact for chemoprophylactic prevention of tuberculosis activation during biologics therapy. Clin Vaccine Immunol. 2013;20:842–7.
22. J.Askling, C.M.Fored, L.Brandt, E.Baecklund, L.Bertilsson, L.Coster, et al. Risk and case characteristics of tuberculosis in rheumatoid arthritis associated with tumor necrosis factor antagonists in Sweden. Arthritis Rheum. 2005;52:1986–92.
23. J.J.Gomez-Reino, L.Carmona, V.R.Valverde, E.M.Mola, M.D.Montero Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. Arthritis Rheum. 2003;48:2122–7.
24. I.Solovic, M.Sester, J.J.Gomez-Reino, H.L.Rieder, S.Ehlers, H.J.Milburn, et al. The risk of tuberculosis related to tumour necrosis factor antagonist therapies: a TBNET consensus statement. Eur Respir J. 2010;36:1185–206.
25. R.S.Wallis, M.Broder, J.Wong, D.Beenhouwer Granulomatous infections due to tumor necrosis factor blockade: correction. Clin Infect Dis. 2004;39:1254–5.
26. F.Wolfe, K.Michaud, J.Anderson, K.Urbansky Tuberculosis infection in patients with rheumatoid arthritis and the effect of infliximab therapy. Arthritis Rheum. 2004;50:372–9.
27. T.Koike, M.Harigai, S.Inokuma, N.Ishiguro, J.Ryu, T.Takeuchi, et al. Postmarketing surveillance of tocilizumab for rheumatoid arthritis in Japan: interim analysis of 3881 patients. Ann Rheum Dis. 2011;70:2148–51.
28. T.Koike, M.Harigai, N.Ishiguro, S.Inokuma, S.Takei, T.Takeuchi, et al. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of 7740 patients. Mod Rheumatol. 2014;24:390–8.
29. H.G.Nüßlein, R.Alten, M.Galeazzi, H.-M.Lorenz, M.T.Nurmohamed, W.G.Bensen, et al. Prognostic factors for abatacept retention in patients who received at least one prior biologic agent: an interim analysis from the observational, prospective ACTION study. BMC Musculoskelet Disord. 2015;16:176.
30. Y.Tanaka, S.Kubo, H.Yamanaka, K.Amano, S.Hirata, E.Tanaka, et al. Efficacy and safety of abatacept in routine care of patients with rheumatoid arthritis: Orencia(®) as Biological Intensive Treatment for RA (ORBIT) study. Mod Rheumatol. 2014;24:754–72.
31. H.G.Nüßlein, R.Alten, M.Galeazzi, H.M.Lorenz, D.Boumpas, M.T.Nurmohamed, et al. Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6-month interim analysis of the 2-year, observational, prospective ACTION study. BMC Musculoskelet Disord. 2014;15:14.
32. A.Finckh, D.Neto, F.Iannone, E.Loza, E.Lie, P.van Riel, et al. The impact of patient heterogeneity and socioeconomic factors on abatacept retention in rheumatoid arthritis across nine European countries. RMD Open 2015;1:e000040.
33. J.E.Gottenberg, P.Ravaud, A.Cantagrel, B.Combe, R.M.Flipo, T.Schaeverbeke, et al. Positivity for anti-cyclic citrullinated peptide is associated with a better response to abatacept: data from the ‘Orencia and Rheumatoid Arthritis’ registry. Ann Rheum Dis. 2012;71:1815–19.