TY - JOUR
T1 - No increased mortality in patients with rheumatoid arthritis treated with biologics
T2 - Results from the biologics register of six rheumatology institutes in Japan
AU - Nakajima, Ayako
AU - Saito, Kazuyoshi
AU - Kojima, Toshihisa
AU - Amano, Koichi
AU - Yoshio, Taku
AU - Fukuda, Wataru
AU - Inoue, Eisuke
AU - Taniguchi, Atsuo
AU - Momohara, Shigeki
AU - Minota, Seiji
AU - Takeuchi, Tsutomu
AU - Ishiguro, Naoki
AU - Tanaka, Yoshiya
AU - Yamanaka, Hisashi
N1 - Funding Information:
Acknowledgments This study was conducted with the support of a grant from the Ministry of Health, Labour and Welfare, Japan.
Funding Information:
Conflict of interest A. Nakajima, K. Saito, E. Inoue, W. Fukuda, T. Yoshio, A. Taniguchi, S. Momohara: None. T. Kojima: Abbott Japan, Bristol–Myers Squibb, Chugai Pharmaceutical, Eisai, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, Pfizer Japan, and Takeda Pharmaceutical. S. Minota: Takeda Pharmaceutical, Bristol–Myers, Chugai Pharmaceutical, Mitsubishi Tanabe. K. Amano: Abbott Japan, Chugai Pharmaceutical. N. Ishiguro has received speaking fees from Takeda Pharma, Mitsubishi Tanabe Pharma, Astellas Pharma, Chugai Pharma, Abbott Japan, Bristol–Myers Squibb, Eisai, Janssen Pharma, and Pfizer Japan. T. Takeuchi has received grants from Abbott Japan Co., Ltd., Astellas Pharma, Bristol–Myers K.K., Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Nippon Shinyaku Co., Ltd., Otsuka Pharmaceutical, Pfizer Japan Inc., Sanofi– Aventis K.K., Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., and Teijin Pharma Ltd., speaking fees from Abbott Japan Co., Ltd., Bristol–Myers K.K., Chugai Pharmaceutical Co,. Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., and Takeda Pharmaceutical Co., Ltd., and consultant fees from Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., and Asahi Kasei Medical K.K.Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from Mitsubishi Tanabe Pharma, Abbott Japan, Chugai Pharma, Janssen Pharma, Eisai Pharma, Santen Pharma, Pfizer, Astellas Pharma, Daiichi Sankyo, GlaxoSmithKline, Astra-Zeneca, Otsuka Pharma, Actelion Pharma Japan, and Eli Lilly Japan, and has received research grant support from Bristol–Myers Squibb, MSD, Chugai Pharma, Mitsubishi Tanabe Pharma, Astellas Pharma, Abbott Japan, Eisai Pharma, and Janssen Pharma. H. Yamanaka has received speaking fees from Abbott Japan Co., Ltd., AstraZeneca K.K., Bristol–Myers Squibb, Chugai Pharmaceutical Co., Ltd., Daii-chi Sankyo Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Corporation, Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc., Takeda Pharmaceutical Company Ltd., Teijin Pharma Limited, and UCB Japan Co. Ltd. The IORRA study is supported by 38 pharmaceutical companies: Asahikasei Kuraray Medical Co., Ltd., Abbott Japan Co., Ltd., Asahikasei Pharma Corporation, Astellas Pharma Inc., AstraZeneca K.K., Bristol–Myers Squibb, Chugai Pharmaceutical Co., Ltd., Daiichi Fine Chemical Co., Ltd., Daiichi Sankyo Co., Ltd., Dainippon Sumitomo Pharma Co., Ltd., Eisai Co., Ltd., GlaxoSmithKline K.K., Hisamitsu Pharmaceutical Co., Inc., Janssen Pharmaceutical K.K., Japan Tobacco Inc., Kaken Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Kowa Pharmaceutical Co. Ltd., Mitsubishi Chemical Medience Corporation, Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd., MSD K.K., Mundipharma K.K., Nippon Chemiphar Co., Ltd., Nippon Shinyaku Co., Ltd., Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sanofi Aventis K.K., Santen Pharmaceutical Co., Ltd., Sanwa Kagaku Kenkyusho Co., Ltd., Sekisui Medical Co., Ltd., Taishotoyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Ltd., Teijin Pharma Ltd., Torii Pharmaceutical Co., Ltd., UCB Japan Co. Ltd., and ZERIA Pharmaceutical Co., Ltd.
Copyright:
Copyright 2013 Elsevier B.V., All rights reserved.
PY - 2013/9
Y1 - 2013/9
N2 - Objective: To investigate the influence of biologics on mortality and risk factors for death in rheumatoid arthritis (RA) patients. Methods: RA patients treated with at least one dose of biologics in daily practice in six large rheumatology institutes ("biologics cohort") were observed until 15 May 2010 or death, whichever occurred first. Mortality of the biologics cohort and the "comparator cohort" (comprising patients among the IORRA cohort who had never been treated with biologics) was compared to that of the Japanese general population. Factors associated with mortality were assessed by a Cox model. Results: Among 2683 patients with 6913.0 patient-years of observation, 38 deaths were identified in the biologics cohort. The probability of death in patients lost to follow-up, calculated using the weighted standardized mortality ratio (SMR), was 1.08 [95 % confidence interval (CI) 0.77-1.47] in the biologics cohort and 1.28 (95 % CI 1.17-1.41) in the comparator cohort. Pulmonary involvement was the main cause of death (47.4 %), and the disease-specific SMR of pneumonia was 4.19 (95 % CI 1.81-8.25). Risk factors for death included male gender [hazard ratio (HR) 2.78 (95 % CI 1.24-6.22)], advanced age (HR 1.07, 95 % CI 1.03-1.11), and corticosteroid dose (HR 1.08, 95 % CI 1.01-1.17). Conclusion: Mortality in RA patients exposed to biologics did not exceed that in patients not exposed to biologics, but death from pulmonary manifestations was proportionally increased in RA patients exposed to biologics.
AB - Objective: To investigate the influence of biologics on mortality and risk factors for death in rheumatoid arthritis (RA) patients. Methods: RA patients treated with at least one dose of biologics in daily practice in six large rheumatology institutes ("biologics cohort") were observed until 15 May 2010 or death, whichever occurred first. Mortality of the biologics cohort and the "comparator cohort" (comprising patients among the IORRA cohort who had never been treated with biologics) was compared to that of the Japanese general population. Factors associated with mortality were assessed by a Cox model. Results: Among 2683 patients with 6913.0 patient-years of observation, 38 deaths were identified in the biologics cohort. The probability of death in patients lost to follow-up, calculated using the weighted standardized mortality ratio (SMR), was 1.08 [95 % confidence interval (CI) 0.77-1.47] in the biologics cohort and 1.28 (95 % CI 1.17-1.41) in the comparator cohort. Pulmonary involvement was the main cause of death (47.4 %), and the disease-specific SMR of pneumonia was 4.19 (95 % CI 1.81-8.25). Risk factors for death included male gender [hazard ratio (HR) 2.78 (95 % CI 1.24-6.22)], advanced age (HR 1.07, 95 % CI 1.03-1.11), and corticosteroid dose (HR 1.08, 95 % CI 1.01-1.17). Conclusion: Mortality in RA patients exposed to biologics did not exceed that in patients not exposed to biologics, but death from pulmonary manifestations was proportionally increased in RA patients exposed to biologics.
KW - Biologics
KW - Cause of death
KW - Mortality
KW - Rheumatoid arthritis
KW - Standardized mortality ratio
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U2 - 10.1007/s10165-012-0773-z
DO - 10.1007/s10165-012-0773-z
M3 - Article
C2 - 23073692
AN - SCOPUS:84885171585
VL - 23
SP - 945
EP - 952
JO - Modern Rheumatology
JF - Modern Rheumatology
SN - 1439-7595
IS - 5
ER -