Improved safety of biologic therapy for rheumatoid arthritis over the 8-year period since implementation in Japan: long-term results from a multicenter observational cohort study
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- 作者：Toshihisa Kojima ; Nobunori Takahashi ; Koji Funahashi ; Shuji Asai…
- 关键词：Adverse event ; Biologics ; Rheumatoid arthritis ; Safety
- 刊名：Clinical Rheumatology
- 出版年：2016
- 出版时间：April 2016
- 年：2016
- 卷：35
- 期：4
- 页码：863-871
- 全文大小：469 KB
- 参考文献：1.Smolen JS, Aletaha D, Bijlsma JW, Breedveld FC, Boumpas D, Burmester G et al (2010) Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis 69:631–637CrossRef PubMed PubMedCentral
2.Silman A, Symmons D, Scott DG, Griffiths I (2003) British society for rheumatology biologics register. Ann Rheum Dis 62(Suppl 2):ii28–ii29PubMed PubMedCentral
3.Hetland ML (2005) DANBIO: a nationwide registry of biological therapies in Denmark. Clin Exp Rheumatol 23:S205–S207PubMed
4.Listing J, Strangfeld A, Rau R, Kekow J, Gromnica-Ihle E, Klopsch T et al (2006) Clinical and functional remission: even though biologics are superior to conventional DMARDs overall success rates remain low—results from RABBIT, the German biologics register. Arthritis Res Ther 8:R66CrossRef PubMed PubMedCentral
5.Du Pan SM, Dehler S, Ciurea A, Ziswiler HR, Gabay C, Finckh A et al (2009) Comparison of drug retention rates and causes of drug discontinuation between anti-tumor necrosis factor agents in rheumatoid arthritis. Arthritis Rheum 61:560–568CrossRef PubMed
6.Kievit W, Adang EM, Fransen J, Kuper HH, van de Laar MA, Jansen TL et al (2008) The effectiveness and medication costs of three anti-tumour necrosis factor alpha agents in the treatment of rheumatoid arthritis from prospective clinical practice data. Ann Rheum Dis 67:1229–1234CrossRef PubMed
7.Heiberg MS, Koldingsnes W, Mikkelsen K, Rodevand E, Kaufmann C, Mowinckel P et al (2008) The comparative one-year performance of anti-tumor necrosis factor alpha drugs in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: results from a longitudinal, observational, multicenter study. Arthritis Rheum 59:234–240CrossRef PubMed
8.Hetland ML, Christensen IJ, Tarp U, Dreyer L, Hansen A, Hansen IT et al (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 62:22–32CrossRef PubMed
9.Marchesoni A, Zaccara E, Gorla R, Bazzani C, Sarzi-Puttini P, Atzeni F et al (2009) TNF-alpha antagonist survival rate in a cohort of rheumatoid arthritis patients observed under conditions of standard clinical practice. Ann N Y Acad Sci 1173:837–846CrossRef PubMed
10.Brocq O, Roux CH, Albert C, Breuil V, Aknouche N, Ruitord S et al (2007) TNFalpha antagonist continuation rates in 442 patients with inflammatory joint disease. Joint Bone Spine 74:148–154CrossRef PubMed
11.Yazici Y, Krasnokutsky S, Barnes JP, Hines PL, Wang J, Rosenblatt L (2009) Changing patterns of tumor necrosis factor inhibitor use in 9074 patients with rheumatoid arthritis. J Rheumatol 36:907–913CrossRef PubMed
12.Greenberg JD, Reed G, Decktor D, Harrold L, Furst D, Gibofsky A et al (2012) A comparative effectiveness study of adalimumab, etanercept and infliximab in biologically naive and switched rheumatoid arthritis patients: results from the US CORRONA registry. Ann Rheum Dis 71:1134–1142CrossRef PubMed
13.Neovius M, Arkema EV, Olsson H, Eriksson JK, Kristensen LE, Simard JF et al (2015) Drug survival on TNF inhibitors in patients with rheumatoid arthritis comparison of adalimumab, etanercept and infliximab. Ann Rheum Dis 74:354–360CrossRef PubMed PubMedCentral
14.Kojima T, Kaneko A, Hirano Y, Ishikawa H, Miyake H, Oguchi T et al (2012) Study protocol of a multicenter registry of patients with rheumatoid arthritis starting biologic therapy in Japan: Tsurumai Biologics Communication Registry (TBCR) study. Mod Rheumatol 22:339–345CrossRef PubMed
15.Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J et al (2009) Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis 68:954–960CrossRef PubMed PubMedCentral
16.Sakai R, Cho SK, Nanki T, Koike R, Watanabe K, Yamazaki H et al (2014) The risk of serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors decreased over time: a report from the registry of Japanese rheumatoid arthritis patients on biologics for long-term safety (REAL) database. Rheumatol Int - 作者单位：Toshihisa Kojima (1)
Nobunori Takahashi (1)
Koji Funahashi (1)
Shuji Asai (1)
Kenya Terabe (1)
Atsushi Kaneko (2)
Yuji Hirano (3)
Masatoshi Hayashi (4)
Hiroyuki Miyake (5)
Takeshi Oguchi (6)
Hideki Takagi (7)
Yasuhide Kanayama (8)
Yuichiro Yabe (9)
Tsuyoshi Watanabe (10)
Takayoshi Fujibayashi (11)
Tomone Shioura (12)
Takayasu Ito (13)
Yutaka Yoshioka (14)
Hisato Ishikawa (15)
Nobuyuki Asai (1)
Toki Takemoto (1)
Masayo Kojima (16)
Naoki Ishiguro (1)
1. Department of Orthopedic Surgery & Rheumatology, Nagoya University Hospital, 65 Tsurumai, Showa, Nagoya, Japan, 466-8550
2. Department of Orthopedic Surgery, Nagoya Medical Center, Nagoya, Japan
3. Department of Rheumatology, Toyohashi Municipal Hospital, Toyohashi, Japan
4. Department of Rheumatology, Nagano Red Cross Hospital, Nagano, Japan
5. Department of Orthopedic Surgery, Ichinomiya Municipal Hospital, Ichinomiya, Japan
6. Department of Orthopedic Surgery, Anjo Kosei Hospital, Anjo, Japan
7. Department of Orthopedic Surgery, Nagoya Central Hospital, Nagoya, Japan
8. Department of Rheumatology, Toyota Kosei Hospital, Nagoya, Japan
9. Department of Rheumatology, JCHO Tokyo Sinjuku Medical Center, Tokyo, Japan
10. Department of Orthopedic Surgery, Kariya–Toyota General Hospital, Kariya, Japan
11. Department of Orthopedic Surgery, Konan Kosei Hospital, Konan, Japan
12. Department of Orthopedic Surgery, Shizuoka Kosei Hospital, Shizuoka, Japan
13. Ito Orthopedic Clinic, Nagoya, Japan
14. Department of Orthopedic Surgery, Handa Municipal Hospital, Handa, Japan
15. Department of Rheumatology, Japanese Red Cross, Nagoya Daiichi Hospital, Nagoya, Japan
16. Department of Public Health, Faculty & Graduate School of Medicine, Nagoya City University, Nagoya, Japan - 刊物类别：Medicine
- 刊物主题：Medicine & Public Health
Rheumatology - 出版者：Springer London
- ISSN：1434-9949
文摘
This study aimed to compare the long-term safety of biologics by initiation year of treatment in patients with rheumatoid arthritis (RA) in Japan. RA patients who started their first biologics including infliximab, etanercept, adalimumab, and tocilizumab between 2003 and 2008 were identified in the Tsurumai Biologics Communication Registry (TBCR), multicenter observational cohort, and followed for 2 years or until discontinuation of the drugs. We identified baseline predictors for adverse events (AEs) resulting in discontinuation of the first TNFI using Cox proportional hazards regression analysis. A total of 874 cases (1,340 person-years) were observed. During the observation period, 96 AEs (4.7 events/100 person-years) occurred. From 2003 to 2008, there were significant changes in disease duration, Steinbrocker stage, and disease activity in those aged ≤64 years with no increase of incidence of AEs, whereas those aged >64 years had no significant changes in these variables. In the later initiation year of treatment with biologics, the fewer AEs were observed (log-rank, p = 0.017, 2008 vs. 2003–2005). Multivariate analysis showed that the initiation year significantly impacted the incidence of AEs 6 months into the observation period [initiation at 2008 (vs. 2003–2005): OR: 0.30, 95 % CI: (0.14–0.68)] after adjusting for variables at baseline. The decrease of AEs in the later initiation year was evident in those aged >64 years. The safety of biologic therapy improved over the course of the 8 years from its implementation in Japan.