PMID- 26846135 OWN - NLM STAT- MEDLINE DCOM- 20170116 LR - 20181113 IS - 1434-9949 (Electronic) IS - 0770-3198 (Linking) VI - 35 IP - 4 DP - 2016 Apr TI - 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. PG - 863-71 LID - 10.1007/s10067-016-3201-5 [doi] AB - 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 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. FAU - Kojima, Toshihisa AU - Kojima T AD - Department of Orthopedic Surgery & Rheumatology, Nagoya University Hospital, 65 Tsurumai, Showa, Nagoya, Japan, 466-8550. toshik@med.nagoya-u.ac.jp. FAU - Takahashi, Nobunori AU - Takahashi N AD - Department of Orthopedic Surgery & Rheumatology, Nagoya University Hospital, 65 Tsurumai, Showa, Nagoya, Japan, 466-8550. FAU - Funahashi, Koji AU - Funahashi K AD - Department of Orthopedic Surgery & Rheumatology, Nagoya University Hospital, 65 Tsurumai, Showa, Nagoya, Japan, 466-8550. FAU - Asai, Shuji AU - Asai S AD - Department of Orthopedic Surgery & Rheumatology, Nagoya University Hospital, 65 Tsurumai, Showa, Nagoya, Japan, 466-8550. FAU - Terabe, Kenya AU - Terabe K AD - Department of Orthopedic Surgery & Rheumatology, Nagoya University Hospital, 65 Tsurumai, Showa, Nagoya, Japan, 466-8550. FAU - Kaneko, Atsushi AU - Kaneko A AD - Department of Orthopedic Surgery, Nagoya Medical Center, Nagoya, Japan. FAU - Hirano, Yuji AU - Hirano Y AD - Department of Rheumatology, Toyohashi Municipal Hospital, Toyohashi, Japan. FAU - Hayashi, Masatoshi AU - Hayashi M AD - Department of Rheumatology, Nagano Red Cross Hospital, Nagano, Japan. FAU - Miyake, Hiroyuki AU - Miyake H AD - Department of Orthopedic Surgery, Ichinomiya Municipal Hospital, Ichinomiya, Japan. FAU - Oguchi, Takeshi AU - Oguchi T AD - Department of Orthopedic Surgery, Anjo Kosei Hospital, Anjo, Japan. FAU - Takagi, Hideki AU - Takagi H AD - Department of Orthopedic Surgery, Nagoya Central Hospital, Nagoya, Japan. FAU - Kanayama, Yasuhide AU - Kanayama Y AD - Department of Rheumatology, Toyota Kosei Hospital, Nagoya, Japan. FAU - Yabe, Yuichiro AU - Yabe Y AD - Department of Rheumatology, JCHO Tokyo Sinjuku Medical Center, Tokyo, Japan. FAU - Watanabe, Tsuyoshi AU - Watanabe T AD - Department of Orthopedic Surgery, Kariya-Toyota General Hospital, Kariya, Japan. FAU - Fujibayashi, Takayoshi AU - Fujibayashi T AD - Department of Orthopedic Surgery, Konan Kosei Hospital, Konan, Japan. FAU - Shioura, Tomone AU - Shioura T AD - Department of Orthopedic Surgery, Shizuoka Kosei Hospital, Shizuoka, Japan. FAU - Ito, Takayasu AU - Ito T AD - Ito Orthopedic Clinic, Nagoya, Japan. FAU - Yoshioka, Yutaka AU - Yoshioka Y AD - Department of Orthopedic Surgery, Handa Municipal Hospital, Handa, Japan. FAU - Ishikawa, Hisato AU - Ishikawa H AD - Department of Rheumatology, Japanese Red Cross, Nagoya Daiichi Hospital, Nagoya, Japan. FAU - Asai, Nobuyuki AU - Asai N AD - Department of Orthopedic Surgery & Rheumatology, Nagoya University Hospital, 65 Tsurumai, Showa, Nagoya, Japan, 466-8550. FAU - Takemoto, Toki AU - Takemoto T AD - Department of Orthopedic Surgery & Rheumatology, Nagoya University Hospital, 65 Tsurumai, Showa, Nagoya, Japan, 466-8550. FAU - Kojima, Masayo AU - Kojima M AD - Department of Public Health, Faculty & Graduate School of Medicine, Nagoya City University, Nagoya, Japan. FAU - Ishiguro, Naoki AU - Ishiguro N AD - Department of Orthopedic Surgery & Rheumatology, Nagoya University Hospital, 65 Tsurumai, Showa, Nagoya, Japan, 466-8550. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20160205 PL - Germany TA - Clin Rheumatol JT - Clinical rheumatology JID - 8211469 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antirheumatic Agents) RN - B72HH48FLU (Infliximab) RN - FYS6T7F842 (Adalimumab) RN - I031V2H011 (tocilizumab) RN - OP401G7OJC (Etanercept) SB - IM MH - Adalimumab/therapeutic use MH - Adult MH - Aged MH - Antibodies, Monoclonal, Humanized/therapeutic use MH - Antirheumatic Agents/therapeutic use MH - Arthritis, Rheumatoid/*therapy MH - Biological Therapy/*methods MH - Cohort Studies MH - Etanercept/therapeutic use MH - Female MH - Humans MH - Infliximab/therapeutic use MH - Japan MH - Male MH - Middle Aged MH - Patient Safety MH - Proportional Hazards Models MH - Registries MH - Risk Factors MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Adverse event OT - Biologics OT - Rheumatoid arthritis OT - Safety EDAT- 2016/02/06 06:00 MHDA- 2017/01/17 06:00 CRDT- 2016/02/06 06:00 PHST- 2015/07/07 00:00 [received] PHST- 2016/01/28 00:00 [accepted] PHST- 2016/01/13 00:00 [revised] PHST- 2016/02/06 06:00 [entrez] PHST- 2016/02/06 06:00 [pubmed] PHST- 2017/01/17 06:00 [medline] AID - 10.1007/s10067-016-3201-5 [pii] AID - 10.1007/s10067-016-3201-5 [doi] PST - ppublish SO - Clin Rheumatol. 2016 Apr;35(4):863-71. doi: 10.1007/s10067-016-3201-5. Epub 2016 Feb 5.