Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis
Takao Koike, Masayoshi Harigai, Shigeko Inokuma, Naoki Ishiguro, Junnosuke Ryu, Tsutomu Takeuchi, Yoshiya Tanaka, Hisashi Yamanaka, Koichi Fujii, Takunari Yoshinaga, Bruce Freundlich, Michio Suzukawa
Our aim was to evaluate real-world safety and effectiveness in a 6-month postmarketing surveillance study covering all Japanese patients with rheumatoid arthritis (RA) who received etanercept during a 2-year period. Data for 13,894 patients (1334 sites) enrolled between March 2005 and April 2007 were collected. Adverse events (AEs) and serious adverse events (SAEs) were reported in 4336 (31.2%) and 857 (6.2%) patients, respectively. The most frequent AEs were injection site reactions (n = 610, 4.4%) and rash (n = 339, 2.4%), whereas pneumonia (n = 116, 0.8%) and interstitial lung disease (n = 77, 0.6%) were the most frequent SAEs. Significant improvement in the proportion of patients with a good European League Against Rheumatism (EULAR) response was observed from week 4 (17.6%) to week 24 (31.6%) (p<0.001); 84.3% of patients had good or moderate EULAR responses at week 24. The percentage of patients achieving remission increased significantly from week 4 (9.3%) to week 24 (18.9%) (p<0.001). Patients with early moderate RA were less likely to experience SAEs and were more likely to achieve remission compared with patients with more severe disease. The safety and effectiveness of etanercept was demonstrated in Japanese patients in one of the largest observational trials conducted thus far in RA patients treated with biologics.
Modern rheumatology
DAS28
Postmarketing surveillance study
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Etanercept Medicine & Life Sciences
Rheumatoid Arthritis Medicine & Life Sciences
Safety Medicine & Life Sciences
Rheumatic Diseases Medicine & Life Sciences
Injection Site Reaction Medicine & Life Sciences
Interstitial Lung Diseases Medicine & Life Sciences
Biological Products Medicine & Life Sciences
Koike, T., Harigai, M., Inokuma, S., Ishiguro, N., Ryu, J., Takeuchi, T., Tanaka, Y., Yamanaka, H., Fujii, K., Yoshinaga, T., Freundlich, B., & Suzukawa, M. (2011). Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis. Modern rheumatology, 21(4), 343-351. https://doi.org/10.1007/s10165-010-0406-3
Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis. / Koike, Takao; Harigai, Masayoshi; Inokuma, Shigeko; Ishiguro, Naoki; Ryu, Junnosuke; Takeuchi, Tsutomu; Tanaka, Yoshiya; Yamanaka, Hisashi; Fujii, Koichi; Yoshinaga, Takunari; Freundlich, Bruce; Suzukawa, Michio.
In: Modern rheumatology, Vol. 21, No. 4, 08.2011, p. 343-351.
Koike, T, Harigai, M, Inokuma, S, Ishiguro, N, Ryu, J, Takeuchi, T, Tanaka, Y, Yamanaka, H, Fujii, K, Yoshinaga, T, Freundlich, B & Suzukawa, M 2011, 'Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis', Modern rheumatology, vol. 21, no. 4, pp. 343-351. https://doi.org/10.1007/s10165-010-0406-3
Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T et al. Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis. Modern rheumatology. 2011 Aug;21(4):343-351. https://doi.org/10.1007/s10165-010-0406-3
Koike, Takao ; Harigai, Masayoshi ; Inokuma, Shigeko ; Ishiguro, Naoki ; Ryu, Junnosuke ; Takeuchi, Tsutomu ; Tanaka, Yoshiya ; Yamanaka, Hisashi ; Fujii, Koichi ; Yoshinaga, Takunari ; Freundlich, Bruce ; Suzukawa, Michio. / Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis. In: Modern rheumatology. 2011 ; Vol. 21, No. 4. pp. 343-351.
@article{12d42b403d7b45be85c07f7ea9ba5dc4,
title = "Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis",
abstract = "Our aim was to evaluate real-world safety and effectiveness in a 6-month postmarketing surveillance study covering all Japanese patients with rheumatoid arthritis (RA) who received etanercept during a 2-year period. Data for 13,894 patients (1334 sites) enrolled between March 2005 and April 2007 were collected. Adverse events (AEs) and serious adverse events (SAEs) were reported in 4336 (31.2%) and 857 (6.2%) patients, respectively. The most frequent AEs were injection site reactions (n = 610, 4.4%) and rash (n = 339, 2.4%), whereas pneumonia (n = 116, 0.8%) and interstitial lung disease (n = 77, 0.6%) were the most frequent SAEs. Significant improvement in the proportion of patients with a good European League Against Rheumatism (EULAR) response was observed from week 4 (17.6%) to week 24 (31.6%) (p<0.001); 84.3% of patients had good or moderate EULAR responses at week 24. The percentage of patients achieving remission increased significantly from week 4 (9.3%) to week 24 (18.9%) (p<0.001). Patients with early moderate RA were less likely to experience SAEs and were more likely to achieve remission compared with patients with more severe disease. The safety and effectiveness of etanercept was demonstrated in Japanese patients in one of the largest observational trials conducted thus far in RA patients treated with biologics.",
keywords = "DAS28, Etanercept, Postmarketing surveillance study, Rheumatoid arthritis",
author = "Takao Koike and Masayoshi Harigai and Shigeko Inokuma and Naoki Ishiguro and Junnosuke Ryu and Tsutomu Takeuchi and Yoshiya Tanaka and Hisashi Yamanaka and Koichi Fujii and Takunari Yoshinaga and Bruce Freundlich and Michio Suzukawa",
note = "Funding Information: Acknowledgments The authors wish to acknowledge the contributions of the late Professor Kazuhiko Inoue, MD, PhD, who participated in this work. This report was prepared with the assistance of Joanne Foehl (previously of Pfizer Inc., Global Medical Affairs) and Complete Healthcare Communications Inc., Chadds Ford, PA, USA. This study was sponsored by Wyeth, and clinical fees were shared by Wyeth K.K. and Takeda Pharmaceutical Company Limited, Wyeth K.K.{\textquoteright}s copromotion partner for etanercept in Japan. Wyeth was integrated into Pfizer in October 2009. Pursuant to the Pharmaceutical Affairs Law of Japan and the regulations promulgated thereunder, the Sponsor (Wyeth) was required to conduct a PMS program as a condition for the marketing approval of etanercept. Wyeth was responsible for the development of the study protocol (with instruction from the PMDA and advice from the Japan College of Rheumatology (JCR) PMS committee) and for the initial analysis of the data. Funding Information: Conflict of interest Doctors T. Koike, M. Harigai, S. Inokuma, N. Ishiguro, J. Ryu, T. Takeuchi, Y. Tanaka, and H. Yamanaka are all members of the Etanercept Postmarketing Surveillance Committee of the Japan College of Rheumatology. It is the belief of the first author that this position does not constitute a Conflict of Interest. The doctors participated in the review and analysis of the PMS data in their capacity as Committee members and are so listed. The financial relationships of the authors with all manufacturers of biological products used in the management of RA are as follows. #1 is a research grant to the institute to which they are affiliated, #2 is a consulting fee, #3 is membership of a speakers{\textquoteright} bureau, #4 is a full-time employee, and #5 is a previous employee of Pfizer. T. Koike, Abbott Japan, 1; Bristol-Myers Squibb, 1; Chugai Pharmaceutical Co. Ltd, 1; Eisai Co. Ltd, 1; Mitsubishi Tanabe Pharma, 1; Takeda Pharmaceutical Co. Ltd, 1; Wyeth KK, 1; Otsuka Pharmaceutical Co. Ltd, 2; Abbott Japan, 3; Bristol-Myers Squibb, 3; Chugai Pharmaceutical Co. Ltd, 3; Eisai Co. Ltd, 3; Mitsubishi Tanabe Pharma, 3; Takeda Pharmaceutical Co. Ltd, 3; Wyeth KK, 3; M. Harigai, Abbott Japan, 1; Bristol-Myers Squibb, 1; Chugai Pharmaceutical Co. Ltd, 1; Eisai Co. Ltd, 1; Mitsubishi Tanabe Pharma, 1; Pfizer Japan Inc., 1; Takeda Pharmaceutical Co. Ltd, 1; Abbott Japan, 2; Chugai Pharmaceutical Co. Ltd, 2; Mitsubishi Tanabe Pharma, 2; Abbott Japan, 3; Bristol-Myers Squibb, 3; Chugai Pharmaceutical Co. Ltd, 3; Eisai Co. Ltd, 3; Mitsubishi Tanabe Pharma, 3; Pfizer Japan Inc., 3; Takeda Pharmaceutical Co. Ltd, 3; S. Inokuma, None; N. Ishiguro, Abbott, 1; Chugai Pharmaceutical Co. Ltd, 1; Daiichi-Sankyo Pharmaceutical Co. Ltd, 1; Eisai Co. Ltd, 1; Mitsubishi Tanabe Pharma, 1; Takeda Pharmaceutical Co. Ltd, 1; Wyeth KK, 1; Abbott, 3; Bristol-Myers Squibb, 3; Chugai Pharmaceutical Co. Ltd, 3; Daiichi-Sankyo Pharmaceutical Co. Ltd, 3; Eisai Co. Ltd, 3; Mitsubishi Tanabe Pharma, 3; Takeda Pharmaceutical Co. Ltd, 3; Wyeth KK, 3; J. Ryu, None; T. Takeuchi, Bristol-Myers Squibb, 2; Mitsubishi Tanabe Pharma, 2; Novartis, 2; Abbott, 3; Chugai Pharmaceutical Co. Ltd, 3; Eisai Pharma, 3; Mitsubishi Tanabe Pharma, 3; Takeda Pharmaceutical Co. Ltd, 3; Y. Tanaka, Abbott, 1; Astellas Pharma Inc., 1; Chugai Pharmaceutical Co. Ltd, 1; Eisai Co. Ltd, 1; Mitsubishi Tanabe Pharma, 1; MSD KK, 1; Pfizer Inc., 1; Takeda Pharmaceutical Co. Ltd, 1; Mitsubishi Tanabe Pharma, 2; Abbott, 3; Astellas Pharma Inc., 3; Chugai Pharmaceutical Co. Ltd, 3; Eisai Co. Ltd, 3; Mitsubishi",
journal = "Modern Rheumatology",
publisher = "Springer Japan",
T1 - Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis
AU - Koike, Takao
AU - Harigai, Masayoshi
AU - Inokuma, Shigeko
AU - Ishiguro, Naoki
AU - Ryu, Junnosuke
AU - Takeuchi, Tsutomu
AU - Tanaka, Yoshiya
AU - Yamanaka, Hisashi
AU - Fujii, Koichi
AU - Yoshinaga, Takunari
AU - Freundlich, Bruce
AU - Suzukawa, Michio
N1 - Funding Information: Acknowledgments The authors wish to acknowledge the contributions of the late Professor Kazuhiko Inoue, MD, PhD, who participated in this work. This report was prepared with the assistance of Joanne Foehl (previously of Pfizer Inc., Global Medical Affairs) and Complete Healthcare Communications Inc., Chadds Ford, PA, USA. This study was sponsored by Wyeth, and clinical fees were shared by Wyeth K.K. and Takeda Pharmaceutical Company Limited, Wyeth K.K.'s copromotion partner for etanercept in Japan. Wyeth was integrated into Pfizer in October 2009. Pursuant to the Pharmaceutical Affairs Law of Japan and the regulations promulgated thereunder, the Sponsor (Wyeth) was required to conduct a PMS program as a condition for the marketing approval of etanercept. Wyeth was responsible for the development of the study protocol (with instruction from the PMDA and advice from the Japan College of Rheumatology (JCR) PMS committee) and for the initial analysis of the data. Funding Information: Conflict of interest Doctors T. Koike, M. Harigai, S. Inokuma, N. Ishiguro, J. Ryu, T. Takeuchi, Y. Tanaka, and H. Yamanaka are all members of the Etanercept Postmarketing Surveillance Committee of the Japan College of Rheumatology. It is the belief of the first author that this position does not constitute a Conflict of Interest. The doctors participated in the review and analysis of the PMS data in their capacity as Committee members and are so listed. The financial relationships of the authors with all manufacturers of biological products used in the management of RA are as follows. #1 is a research grant to the institute to which they are affiliated, #2 is a consulting fee, #3 is membership of a speakers' bureau, #4 is a full-time employee, and #5 is a previous employee of Pfizer. T. Koike, Abbott Japan, 1; Bristol-Myers Squibb, 1; Chugai Pharmaceutical Co. Ltd, 1; Eisai Co. Ltd, 1; Mitsubishi Tanabe Pharma, 1; Takeda Pharmaceutical Co. Ltd, 1; Wyeth KK, 1; Otsuka Pharmaceutical Co. Ltd, 2; Abbott Japan, 3; Bristol-Myers Squibb, 3; Chugai Pharmaceutical Co. Ltd, 3; Eisai Co. Ltd, 3; Mitsubishi Tanabe Pharma, 3; Takeda Pharmaceutical Co. Ltd, 3; Wyeth KK, 3; M. Harigai, Abbott Japan, 1; Bristol-Myers Squibb, 1; Chugai Pharmaceutical Co. Ltd, 1; Eisai Co. Ltd, 1; Mitsubishi Tanabe Pharma, 1; Pfizer Japan Inc., 1; Takeda Pharmaceutical Co. Ltd, 1; Abbott Japan, 2; Chugai Pharmaceutical Co. Ltd, 2; Mitsubishi Tanabe Pharma, 2; Abbott Japan, 3; Bristol-Myers Squibb, 3; Chugai Pharmaceutical Co. Ltd, 3; Eisai Co. Ltd, 3; Mitsubishi Tanabe Pharma, 3; Pfizer Japan Inc., 3; Takeda Pharmaceutical Co. Ltd, 3; S. Inokuma, None; N. Ishiguro, Abbott, 1; Chugai Pharmaceutical Co. Ltd, 1; Daiichi-Sankyo Pharmaceutical Co. Ltd, 1; Eisai Co. Ltd, 1; Mitsubishi Tanabe Pharma, 1; Takeda Pharmaceutical Co. Ltd, 1; Wyeth KK, 1; Abbott, 3; Bristol-Myers Squibb, 3; Chugai Pharmaceutical Co. Ltd, 3; Daiichi-Sankyo Pharmaceutical Co. Ltd, 3; Eisai Co. Ltd, 3; Mitsubishi Tanabe Pharma, 3; Takeda Pharmaceutical Co. Ltd, 3; Wyeth KK, 3; J. Ryu, None; T. Takeuchi, Bristol-Myers Squibb, 2; Mitsubishi Tanabe Pharma, 2; Novartis, 2; Abbott, 3; Chugai Pharmaceutical Co. Ltd, 3; Eisai Pharma, 3; Mitsubishi Tanabe Pharma, 3; Takeda Pharmaceutical Co. Ltd, 3; Y. Tanaka, Abbott, 1; Astellas Pharma Inc., 1; Chugai Pharmaceutical Co. Ltd, 1; Eisai Co. Ltd, 1; Mitsubishi Tanabe Pharma, 1; MSD KK, 1; Pfizer Inc., 1; Takeda Pharmaceutical Co. Ltd, 1; Mitsubishi Tanabe Pharma, 2; Abbott, 3; Astellas Pharma Inc., 3; Chugai Pharmaceutical Co. Ltd, 3; Eisai Co. Ltd, 3; Mitsubishi
N2 - Our aim was to evaluate real-world safety and effectiveness in a 6-month postmarketing surveillance study covering all Japanese patients with rheumatoid arthritis (RA) who received etanercept during a 2-year period. Data for 13,894 patients (1334 sites) enrolled between March 2005 and April 2007 were collected. Adverse events (AEs) and serious adverse events (SAEs) were reported in 4336 (31.2%) and 857 (6.2%) patients, respectively. The most frequent AEs were injection site reactions (n = 610, 4.4%) and rash (n = 339, 2.4%), whereas pneumonia (n = 116, 0.8%) and interstitial lung disease (n = 77, 0.6%) were the most frequent SAEs. Significant improvement in the proportion of patients with a good European League Against Rheumatism (EULAR) response was observed from week 4 (17.6%) to week 24 (31.6%) (p<0.001); 84.3% of patients had good or moderate EULAR responses at week 24. The percentage of patients achieving remission increased significantly from week 4 (9.3%) to week 24 (18.9%) (p<0.001). Patients with early moderate RA were less likely to experience SAEs and were more likely to achieve remission compared with patients with more severe disease. The safety and effectiveness of etanercept was demonstrated in Japanese patients in one of the largest observational trials conducted thus far in RA patients treated with biologics.
AB - Our aim was to evaluate real-world safety and effectiveness in a 6-month postmarketing surveillance study covering all Japanese patients with rheumatoid arthritis (RA) who received etanercept during a 2-year period. Data for 13,894 patients (1334 sites) enrolled between March 2005 and April 2007 were collected. Adverse events (AEs) and serious adverse events (SAEs) were reported in 4336 (31.2%) and 857 (6.2%) patients, respectively. The most frequent AEs were injection site reactions (n = 610, 4.4%) and rash (n = 339, 2.4%), whereas pneumonia (n = 116, 0.8%) and interstitial lung disease (n = 77, 0.6%) were the most frequent SAEs. Significant improvement in the proportion of patients with a good European League Against Rheumatism (EULAR) response was observed from week 4 (17.6%) to week 24 (31.6%) (p<0.001); 84.3% of patients had good or moderate EULAR responses at week 24. The percentage of patients achieving remission increased significantly from week 4 (9.3%) to week 24 (18.9%) (p<0.001). Patients with early moderate RA were less likely to experience SAEs and were more likely to achieve remission compared with patients with more severe disease. The safety and effectiveness of etanercept was demonstrated in Japanese patients in one of the largest observational trials conducted thus far in RA patients treated with biologics.
KW - DAS28
KW - Etanercept
KW - Postmarketing surveillance study
KW - Rheumatoid arthritis
JO - Modern Rheumatology
JF - Modern Rheumatology