Research ArticleArticle
Effectiveness and Safety of Tocilizumab: Postmarketing Surveillance of 7901 Patients with Rheumatoid Arthritis in Japan
Takao Koike, Masayoshi Harigai, Shigeko Inokuma, Naoki Ishiguro, Junnosuke Ryu, Tsutomu Takeuchi, Syuji Takei, Yoshiya Tanaka, Yoko Sano, Hitomi Yaguramaki and Hisashi Yamanaka
The Journal of Rheumatology November 2013, jrheum.130466; DOI: https://doi.org/10.3899/jrheum.130466
Takao Koike
From the Sapporo Medical Center NTT EC, Sapporo; Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, Tokyo; Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, Tokyo; Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Aichi; Nihon University, Tokyo; Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo; School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd., Tokyo; Tokyo Women’s Medical University, Tokyo; Committee on Postmarketing Surveillance of the Japan College of Rheumatology, Tokyo, Japan. Supported by Chugai Pharmaceutical Co. Ltd. T. Koike has received payment for lectures from Abbott, Astellas, Bristol Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe Pharma, Pfizer, Santen, Takeda, Taisyo-Toyama, Teijin, and UCS. M. Harigai has received research grants, speaking fees, or honoraria from Abbott, Astellas Pharma, Bristol-Myers Squibb, Chugai, Eisai Pharmaceuticals, Janssen Pharmaceuticals, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Takeda Pharmaceuticals, UCB Japan, and Pfizer; and has received consultant fees from Abbott, Bristol-Myers Squibb, Chugai, and Janssen Pharmaceuticals. N. Ishiguro has received grants and payment for lectures from Abbott, Chugai, Daiichi-Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer, and Takeda. T. Takeuchi has received research grants, travel funds, and payment for writing or reviewing a manuscript from Asahi Kasei Medical, Astra Zeneca, Bristol-Myers, Eli Lilly, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, and Novartis. S. Takei has received grants from Bristol-Myers Squibb, Chugai, Eisai, and Takeda. Y. Sano and H. Yaguramaki are employees of Chugai. H. Yamanaka has received grants and speaking fees from Chugai. T. Koike, MD, Chief Executive, Sapporo Medical Center NTT EC, and Committee on Postmarketing Surveillance (PMS) of Japan College of Rheumatology; M. Harigai, MD, PhD, Professor, Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, and Committee on PMS of Japan College of Rheumatology; S. Inokuma, MD, Director, Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, and Committee on PMS of Japan College of Rheumatology; N. Ishiguro, MD, PhD, Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, and Committee on PMS of Japan College of Rheumatology; J. Ryu, MD, Nihon University, and Committee on PMS of Japan College of Rheumatology; T. Takeuchi, MD, PhD, Professor, Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, and Committee on PMS of Japan College of Rheumatology; S. Takei, MD, PhD, Professor, School of Health Sciences, Faculty of Medicine, Kagoshima University, and Committee on PMS of Japan College of Rheumatology; Y. Tanaka, MD, PhD, Professor, The First Department of Internal Medicine, University of Occupational and Environmental Health, and Committee on PMS of Japan College of Rheumatology; Y. Sano, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yaguramaki, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yamanaka, MD, Tokyo Women’s Medical University, and Committee on PMS of Japan College of Rheumatology. Address correspondence to Dr. T. Koike, Sapporo Medical Center NTT EC, S 1, W 15, Chuo Ku, Sapporo, Hokkaido, 060 0061, Japan. E-mail: tkoike@med.hokudai.ac.jp. Accepted for publication August 28, 2013.
Masayoshi Harigai
From the Sapporo Medical Center NTT EC, Sapporo; Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, Tokyo; Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, Tokyo; Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Aichi; Nihon University, Tokyo; Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo; School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd., Tokyo; Tokyo Women’s Medical University, Tokyo; Committee on Postmarketing Surveillance of the Japan College of Rheumatology, Tokyo, Japan. Supported by Chugai Pharmaceutical Co. Ltd. T. Koike has received payment for lectures from Abbott, Astellas, Bristol Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe Pharma, Pfizer, Santen, Takeda, Taisyo-Toyama, Teijin, and UCS. M. Harigai has received research grants, speaking fees, or honoraria from Abbott, Astellas Pharma, Bristol-Myers Squibb, Chugai, Eisai Pharmaceuticals, Janssen Pharmaceuticals, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Takeda Pharmaceuticals, UCB Japan, and Pfizer; and has received consultant fees from Abbott, Bristol-Myers Squibb, Chugai, and Janssen Pharmaceuticals. N. Ishiguro has received grants and payment for lectures from Abbott, Chugai, Daiichi-Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer, and Takeda. T. Takeuchi has received research grants, travel funds, and payment for writing or reviewing a manuscript from Asahi Kasei Medical, Astra Zeneca, Bristol-Myers, Eli Lilly, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, and Novartis. S. Takei has received grants from Bristol-Myers Squibb, Chugai, Eisai, and Takeda. Y. Sano and H. Yaguramaki are employees of Chugai. H. Yamanaka has received grants and speaking fees from Chugai. T. Koike, MD, Chief Executive, Sapporo Medical Center NTT EC, and Committee on Postmarketing Surveillance (PMS) of Japan College of Rheumatology; M. Harigai, MD, PhD, Professor, Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, and Committee on PMS of Japan College of Rheumatology; S. Inokuma, MD, Director, Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, and Committee on PMS of Japan College of Rheumatology; N. Ishiguro, MD, PhD, Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, and Committee on PMS of Japan College of Rheumatology; J. Ryu, MD, Nihon University, and Committee on PMS of Japan College of Rheumatology; T. Takeuchi, MD, PhD, Professor, Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, and Committee on PMS of Japan College of Rheumatology; S. Takei, MD, PhD, Professor, School of Health Sciences, Faculty of Medicine, Kagoshima University, and Committee on PMS of Japan College of Rheumatology; Y. Tanaka, MD, PhD, Professor, The First Department of Internal Medicine, University of Occupational and Environmental Health, and Committee on PMS of Japan College of Rheumatology; Y. Sano, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yaguramaki, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yamanaka, MD, Tokyo Women’s Medical University, and Committee on PMS of Japan College of Rheumatology. Address correspondence to Dr. T. Koike, Sapporo Medical Center NTT EC, S 1, W 15, Chuo Ku, Sapporo, Hokkaido, 060 0061, Japan. E-mail: tkoike@med.hokudai.ac.jp. Accepted for publication August 28, 2013.
Shigeko Inokuma
From the Sapporo Medical Center NTT EC, Sapporo; Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, Tokyo; Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, Tokyo; Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Aichi; Nihon University, Tokyo; Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo; School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd., Tokyo; Tokyo Women’s Medical University, Tokyo; Committee on Postmarketing Surveillance of the Japan College of Rheumatology, Tokyo, Japan. Supported by Chugai Pharmaceutical Co. Ltd. T. Koike has received payment for lectures from Abbott, Astellas, Bristol Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe Pharma, Pfizer, Santen, Takeda, Taisyo-Toyama, Teijin, and UCS. M. Harigai has received research grants, speaking fees, or honoraria from Abbott, Astellas Pharma, Bristol-Myers Squibb, Chugai, Eisai Pharmaceuticals, Janssen Pharmaceuticals, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Takeda Pharmaceuticals, UCB Japan, and Pfizer; and has received consultant fees from Abbott, Bristol-Myers Squibb, Chugai, and Janssen Pharmaceuticals. N. Ishiguro has received grants and payment for lectures from Abbott, Chugai, Daiichi-Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer, and Takeda. T. Takeuchi has received research grants, travel funds, and payment for writing or reviewing a manuscript from Asahi Kasei Medical, Astra Zeneca, Bristol-Myers, Eli Lilly, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, and Novartis. S. Takei has received grants from Bristol-Myers Squibb, Chugai, Eisai, and Takeda. Y. Sano and H. Yaguramaki are employees of Chugai. H. Yamanaka has received grants and speaking fees from Chugai. T. Koike, MD, Chief Executive, Sapporo Medical Center NTT EC, and Committee on Postmarketing Surveillance (PMS) of Japan College of Rheumatology; M. Harigai, MD, PhD, Professor, Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, and Committee on PMS of Japan College of Rheumatology; S. Inokuma, MD, Director, Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, and Committee on PMS of Japan College of Rheumatology; N. Ishiguro, MD, PhD, Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, and Committee on PMS of Japan College of Rheumatology; J. Ryu, MD, Nihon University, and Committee on PMS of Japan College of Rheumatology; T. Takeuchi, MD, PhD, Professor, Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, and Committee on PMS of Japan College of Rheumatology; S. Takei, MD, PhD, Professor, School of Health Sciences, Faculty of Medicine, Kagoshima University, and Committee on PMS of Japan College of Rheumatology; Y. Tanaka, MD, PhD, Professor, The First Department of Internal Medicine, University of Occupational and Environmental Health, and Committee on PMS of Japan College of Rheumatology; Y. Sano, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yaguramaki, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yamanaka, MD, Tokyo Women’s Medical University, and Committee on PMS of Japan College of Rheumatology. Address correspondence to Dr. T. Koike, Sapporo Medical Center NTT EC, S 1, W 15, Chuo Ku, Sapporo, Hokkaido, 060 0061, Japan. E-mail: tkoike@med.hokudai.ac.jp. Accepted for publication August 28, 2013.
Naoki Ishiguro
From the Sapporo Medical Center NTT EC, Sapporo; Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, Tokyo; Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, Tokyo; Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Aichi; Nihon University, Tokyo; Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo; School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd., Tokyo; Tokyo Women’s Medical University, Tokyo; Committee on Postmarketing Surveillance of the Japan College of Rheumatology, Tokyo, Japan. Supported by Chugai Pharmaceutical Co. Ltd. T. Koike has received payment for lectures from Abbott, Astellas, Bristol Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe Pharma, Pfizer, Santen, Takeda, Taisyo-Toyama, Teijin, and UCS. M. Harigai has received research grants, speaking fees, or honoraria from Abbott, Astellas Pharma, Bristol-Myers Squibb, Chugai, Eisai Pharmaceuticals, Janssen Pharmaceuticals, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Takeda Pharmaceuticals, UCB Japan, and Pfizer; and has received consultant fees from Abbott, Bristol-Myers Squibb, Chugai, and Janssen Pharmaceuticals. N. Ishiguro has received grants and payment for lectures from Abbott, Chugai, Daiichi-Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer, and Takeda. T. Takeuchi has received research grants, travel funds, and payment for writing or reviewing a manuscript from Asahi Kasei Medical, Astra Zeneca, Bristol-Myers, Eli Lilly, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, and Novartis. S. Takei has received grants from Bristol-Myers Squibb, Chugai, Eisai, and Takeda. Y. Sano and H. Yaguramaki are employees of Chugai. H. Yamanaka has received grants and speaking fees from Chugai. T. Koike, MD, Chief Executive, Sapporo Medical Center NTT EC, and Committee on Postmarketing Surveillance (PMS) of Japan College of Rheumatology; M. Harigai, MD, PhD, Professor, Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, and Committee on PMS of Japan College of Rheumatology; S. Inokuma, MD, Director, Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, and Committee on PMS of Japan College of Rheumatology; N. Ishiguro, MD, PhD, Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, and Committee on PMS of Japan College of Rheumatology; J. Ryu, MD, Nihon University, and Committee on PMS of Japan College of Rheumatology; T. Takeuchi, MD, PhD, Professor, Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, and Committee on PMS of Japan College of Rheumatology; S. Takei, MD, PhD, Professor, School of Health Sciences, Faculty of Medicine, Kagoshima University, and Committee on PMS of Japan College of Rheumatology; Y. Tanaka, MD, PhD, Professor, The First Department of Internal Medicine, University of Occupational and Environmental Health, and Committee on PMS of Japan College of Rheumatology; Y. Sano, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yaguramaki, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yamanaka, MD, Tokyo Women’s Medical University, and Committee on PMS of Japan College of Rheumatology. Address correspondence to Dr. T. Koike, Sapporo Medical Center NTT EC, S 1, W 15, Chuo Ku, Sapporo, Hokkaido, 060 0061, Japan. E-mail: tkoike@med.hokudai.ac.jp. Accepted for publication August 28, 2013.
Junnosuke Ryu
From the Sapporo Medical Center NTT EC, Sapporo; Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, Tokyo; Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, Tokyo; Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Aichi; Nihon University, Tokyo; Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo; School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd., Tokyo; Tokyo Women’s Medical University, Tokyo; Committee on Postmarketing Surveillance of the Japan College of Rheumatology, Tokyo, Japan. Supported by Chugai Pharmaceutical Co. Ltd. T. Koike has received payment for lectures from Abbott, Astellas, Bristol Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe Pharma, Pfizer, Santen, Takeda, Taisyo-Toyama, Teijin, and UCS. M. Harigai has received research grants, speaking fees, or honoraria from Abbott, Astellas Pharma, Bristol-Myers Squibb, Chugai, Eisai Pharmaceuticals, Janssen Pharmaceuticals, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Takeda Pharmaceuticals, UCB Japan, and Pfizer; and has received consultant fees from Abbott, Bristol-Myers Squibb, Chugai, and Janssen Pharmaceuticals. N. Ishiguro has received grants and payment for lectures from Abbott, Chugai, Daiichi-Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer, and Takeda. T. Takeuchi has received research grants, travel funds, and payment for writing or reviewing a manuscript from Asahi Kasei Medical, Astra Zeneca, Bristol-Myers, Eli Lilly, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, and Novartis. S. Takei has received grants from Bristol-Myers Squibb, Chugai, Eisai, and Takeda. Y. Sano and H. Yaguramaki are employees of Chugai. H. Yamanaka has received grants and speaking fees from Chugai. T. Koike, MD, Chief Executive, Sapporo Medical Center NTT EC, and Committee on Postmarketing Surveillance (PMS) of Japan College of Rheumatology; M. Harigai, MD, PhD, Professor, Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, and Committee on PMS of Japan College of Rheumatology; S. Inokuma, MD, Director, Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, and Committee on PMS of Japan College of Rheumatology; N. Ishiguro, MD, PhD, Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, and Committee on PMS of Japan College of Rheumatology; J. Ryu, MD, Nihon University, and Committee on PMS of Japan College of Rheumatology; T. Takeuchi, MD, PhD, Professor, Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, and Committee on PMS of Japan College of Rheumatology; S. Takei, MD, PhD, Professor, School of Health Sciences, Faculty of Medicine, Kagoshima University, and Committee on PMS of Japan College of Rheumatology; Y. Tanaka, MD, PhD, Professor, The First Department of Internal Medicine, University of Occupational and Environmental Health, and Committee on PMS of Japan College of Rheumatology; Y. Sano, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yaguramaki, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yamanaka, MD, Tokyo Women’s Medical University, and Committee on PMS of Japan College of Rheumatology. Address correspondence to Dr. T. Koike, Sapporo Medical Center NTT EC, S 1, W 15, Chuo Ku, Sapporo, Hokkaido, 060 0061, Japan. E-mail: tkoike@med.hokudai.ac.jp. Accepted for publication August 28, 2013.
Tsutomu Takeuchi
From the Sapporo Medical Center NTT EC, Sapporo; Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, Tokyo; Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, Tokyo; Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Aichi; Nihon University, Tokyo; Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo; School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd., Tokyo; Tokyo Women’s Medical University, Tokyo; Committee on Postmarketing Surveillance of the Japan College of Rheumatology, Tokyo, Japan. Supported by Chugai Pharmaceutical Co. Ltd. T. Koike has received payment for lectures from Abbott, Astellas, Bristol Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe Pharma, Pfizer, Santen, Takeda, Taisyo-Toyama, Teijin, and UCS. M. Harigai has received research grants, speaking fees, or honoraria from Abbott, Astellas Pharma, Bristol-Myers Squibb, Chugai, Eisai Pharmaceuticals, Janssen Pharmaceuticals, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Takeda Pharmaceuticals, UCB Japan, and Pfizer; and has received consultant fees from Abbott, Bristol-Myers Squibb, Chugai, and Janssen Pharmaceuticals. N. Ishiguro has received grants and payment for lectures from Abbott, Chugai, Daiichi-Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer, and Takeda. T. Takeuchi has received research grants, travel funds, and payment for writing or reviewing a manuscript from Asahi Kasei Medical, Astra Zeneca, Bristol-Myers, Eli Lilly, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, and Novartis. S. Takei has received grants from Bristol-Myers Squibb, Chugai, Eisai, and Takeda. Y. Sano and H. Yaguramaki are employees of Chugai. H. Yamanaka has received grants and speaking fees from Chugai. T. Koike, MD, Chief Executive, Sapporo Medical Center NTT EC, and Committee on Postmarketing Surveillance (PMS) of Japan College of Rheumatology; M. Harigai, MD, PhD, Professor, Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, and Committee on PMS of Japan College of Rheumatology; S. Inokuma, MD, Director, Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, and Committee on PMS of Japan College of Rheumatology; N. Ishiguro, MD, PhD, Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, and Committee on PMS of Japan College of Rheumatology; J. Ryu, MD, Nihon University, and Committee on PMS of Japan College of Rheumatology; T. Takeuchi, MD, PhD, Professor, Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, and Committee on PMS of Japan College of Rheumatology; S. Takei, MD, PhD, Professor, School of Health Sciences, Faculty of Medicine, Kagoshima University, and Committee on PMS of Japan College of Rheumatology; Y. Tanaka, MD, PhD, Professor, The First Department of Internal Medicine, University of Occupational and Environmental Health, and Committee on PMS of Japan College of Rheumatology; Y. Sano, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yaguramaki, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yamanaka, MD, Tokyo Women’s Medical University, and Committee on PMS of Japan College of Rheumatology. Address correspondence to Dr. T. Koike, Sapporo Medical Center NTT EC, S 1, W 15, Chuo Ku, Sapporo, Hokkaido, 060 0061, Japan. E-mail: tkoike@med.hokudai.ac.jp. Accepted for publication August 28, 2013.
Syuji Takei
From the Sapporo Medical Center NTT EC, Sapporo; Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, Tokyo; Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, Tokyo; Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Aichi; Nihon University, Tokyo; Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo; School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd., Tokyo; Tokyo Women’s Medical University, Tokyo; Committee on Postmarketing Surveillance of the Japan College of Rheumatology, Tokyo, Japan. Supported by Chugai Pharmaceutical Co. Ltd. T. Koike has received payment for lectures from Abbott, Astellas, Bristol Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe Pharma, Pfizer, Santen, Takeda, Taisyo-Toyama, Teijin, and UCS. M. Harigai has received research grants, speaking fees, or honoraria from Abbott, Astellas Pharma, Bristol-Myers Squibb, Chugai, Eisai Pharmaceuticals, Janssen Pharmaceuticals, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Takeda Pharmaceuticals, UCB Japan, and Pfizer; and has received consultant fees from Abbott, Bristol-Myers Squibb, Chugai, and Janssen Pharmaceuticals. N. Ishiguro has received grants and payment for lectures from Abbott, Chugai, Daiichi-Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer, and Takeda. T. Takeuchi has received research grants, travel funds, and payment for writing or reviewing a manuscript from Asahi Kasei Medical, Astra Zeneca, Bristol-Myers, Eli Lilly, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, and Novartis. S. Takei has received grants from Bristol-Myers Squibb, Chugai, Eisai, and Takeda. Y. Sano and H. Yaguramaki are employees of Chugai. H. Yamanaka has received grants and speaking fees from Chugai. T. Koike, MD, Chief Executive, Sapporo Medical Center NTT EC, and Committee on Postmarketing Surveillance (PMS) of Japan College of Rheumatology; M. Harigai, MD, PhD, Professor, Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, and Committee on PMS of Japan College of Rheumatology; S. Inokuma, MD, Director, Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, and Committee on PMS of Japan College of Rheumatology; N. Ishiguro, MD, PhD, Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, and Committee on PMS of Japan College of Rheumatology; J. Ryu, MD, Nihon University, and Committee on PMS of Japan College of Rheumatology; T. Takeuchi, MD, PhD, Professor, Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, and Committee on PMS of Japan College of Rheumatology; S. Takei, MD, PhD, Professor, School of Health Sciences, Faculty of Medicine, Kagoshima University, and Committee on PMS of Japan College of Rheumatology; Y. Tanaka, MD, PhD, Professor, The First Department of Internal Medicine, University of Occupational and Environmental Health, and Committee on PMS of Japan College of Rheumatology; Y. Sano, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yaguramaki, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yamanaka, MD, Tokyo Women’s Medical University, and Committee on PMS of Japan College of Rheumatology. Address correspondence to Dr. T. Koike, Sapporo Medical Center NTT EC, S 1, W 15, Chuo Ku, Sapporo, Hokkaido, 060 0061, Japan. E-mail: tkoike@med.hokudai.ac.jp. Accepted for publication August 28, 2013.
Yoshiya Tanaka
From the Sapporo Medical Center NTT EC, Sapporo; Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, Tokyo; Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, Tokyo; Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Aichi; Nihon University, Tokyo; Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo; School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd., Tokyo; Tokyo Women’s Medical University, Tokyo; Committee on Postmarketing Surveillance of the Japan College of Rheumatology, Tokyo, Japan. Supported by Chugai Pharmaceutical Co. Ltd. T. Koike has received payment for lectures from Abbott, Astellas, Bristol Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe Pharma, Pfizer, Santen, Takeda, Taisyo-Toyama, Teijin, and UCS. M. Harigai has received research grants, speaking fees, or honoraria from Abbott, Astellas Pharma, Bristol-Myers Squibb, Chugai, Eisai Pharmaceuticals, Janssen Pharmaceuticals, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Takeda Pharmaceuticals, UCB Japan, and Pfizer; and has received consultant fees from Abbott, Bristol-Myers Squibb, Chugai, and Janssen Pharmaceuticals. N. Ishiguro has received grants and payment for lectures from Abbott, Chugai, Daiichi-Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer, and Takeda. T. Takeuchi has received research grants, travel funds, and payment for writing or reviewing a manuscript from Asahi Kasei Medical, Astra Zeneca, Bristol-Myers, Eli Lilly, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, and Novartis. S. Takei has received grants from Bristol-Myers Squibb, Chugai, Eisai, and Takeda. Y. Sano and H. Yaguramaki are employees of Chugai. H. Yamanaka has received grants and speaking fees from Chugai. T. Koike, MD, Chief Executive, Sapporo Medical Center NTT EC, and Committee on Postmarketing Surveillance (PMS) of Japan College of Rheumatology; M. Harigai, MD, PhD, Professor, Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, and Committee on PMS of Japan College of Rheumatology; S. Inokuma, MD, Director, Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, and Committee on PMS of Japan College of Rheumatology; N. Ishiguro, MD, PhD, Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, and Committee on PMS of Japan College of Rheumatology; J. Ryu, MD, Nihon University, and Committee on PMS of Japan College of Rheumatology; T. Takeuchi, MD, PhD, Professor, Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, and Committee on PMS of Japan College of Rheumatology; S. Takei, MD, PhD, Professor, School of Health Sciences, Faculty of Medicine, Kagoshima University, and Committee on PMS of Japan College of Rheumatology; Y. Tanaka, MD, PhD, Professor, The First Department of Internal Medicine, University of Occupational and Environmental Health, and Committee on PMS of Japan College of Rheumatology; Y. Sano, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yaguramaki, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yamanaka, MD, Tokyo Women’s Medical University, and Committee on PMS of Japan College of Rheumatology. Address correspondence to Dr. T. Koike, Sapporo Medical Center NTT EC, S 1, W 15, Chuo Ku, Sapporo, Hokkaido, 060 0061, Japan. E-mail: tkoike@med.hokudai.ac.jp. Accepted for publication August 28, 2013.
Yoko Sano
From the Sapporo Medical Center NTT EC, Sapporo; Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, Tokyo; Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, Tokyo; Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Aichi; Nihon University, Tokyo; Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo; School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd., Tokyo; Tokyo Women’s Medical University, Tokyo; Committee on Postmarketing Surveillance of the Japan College of Rheumatology, Tokyo, Japan. Supported by Chugai Pharmaceutical Co. Ltd. T. Koike has received payment for lectures from Abbott, Astellas, Bristol Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe Pharma, Pfizer, Santen, Takeda, Taisyo-Toyama, Teijin, and UCS. M. Harigai has received research grants, speaking fees, or honoraria from Abbott, Astellas Pharma, Bristol-Myers Squibb, Chugai, Eisai Pharmaceuticals, Janssen Pharmaceuticals, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Takeda Pharmaceuticals, UCB Japan, and Pfizer; and has received consultant fees from Abbott, Bristol-Myers Squibb, Chugai, and Janssen Pharmaceuticals. N. Ishiguro has received grants and payment for lectures from Abbott, Chugai, Daiichi-Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer, and Takeda. T. Takeuchi has received research grants, travel funds, and payment for writing or reviewing a manuscript from Asahi Kasei Medical, Astra Zeneca, Bristol-Myers, Eli Lilly, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, and Novartis. S. Takei has received grants from Bristol-Myers Squibb, Chugai, Eisai, and Takeda. Y. Sano and H. Yaguramaki are employees of Chugai. H. Yamanaka has received grants and speaking fees from Chugai. T. Koike, MD, Chief Executive, Sapporo Medical Center NTT EC, and Committee on Postmarketing Surveillance (PMS) of Japan College of Rheumatology; M. Harigai, MD, PhD, Professor, Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, and Committee on PMS of Japan College of Rheumatology; S. Inokuma, MD, Director, Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, and Committee on PMS of Japan College of Rheumatology; N. Ishiguro, MD, PhD, Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, and Committee on PMS of Japan College of Rheumatology; J. Ryu, MD, Nihon University, and Committee on PMS of Japan College of Rheumatology; T. Takeuchi, MD, PhD, Professor, Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, and Committee on PMS of Japan College of Rheumatology; S. Takei, MD, PhD, Professor, School of Health Sciences, Faculty of Medicine, Kagoshima University, and Committee on PMS of Japan College of Rheumatology; Y. Tanaka, MD, PhD, Professor, The First Department of Internal Medicine, University of Occupational and Environmental Health, and Committee on PMS of Japan College of Rheumatology; Y. Sano, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yaguramaki, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yamanaka, MD, Tokyo Women’s Medical University, and Committee on PMS of Japan College of Rheumatology. Address correspondence to Dr. T. Koike, Sapporo Medical Center NTT EC, S 1, W 15, Chuo Ku, Sapporo, Hokkaido, 060 0061, Japan. E-mail: tkoike@med.hokudai.ac.jp. Accepted for publication August 28, 2013.
Hitomi Yaguramaki
From the Sapporo Medical Center NTT EC, Sapporo; Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, Tokyo; Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, Tokyo; Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Aichi; Nihon University, Tokyo; Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo; School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd., Tokyo; Tokyo Women’s Medical University, Tokyo; Committee on Postmarketing Surveillance of the Japan College of Rheumatology, Tokyo, Japan. Supported by Chugai Pharmaceutical Co. Ltd. T. Koike has received payment for lectures from Abbott, Astellas, Bristol Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe Pharma, Pfizer, Santen, Takeda, Taisyo-Toyama, Teijin, and UCS. M. Harigai has received research grants, speaking fees, or honoraria from Abbott, Astellas Pharma, Bristol-Myers Squibb, Chugai, Eisai Pharmaceuticals, Janssen Pharmaceuticals, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Takeda Pharmaceuticals, UCB Japan, and Pfizer; and has received consultant fees from Abbott, Bristol-Myers Squibb, Chugai, and Janssen Pharmaceuticals. N. Ishiguro has received grants and payment for lectures from Abbott, Chugai, Daiichi-Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer, and Takeda. T. Takeuchi has received research grants, travel funds, and payment for writing or reviewing a manuscript from Asahi Kasei Medical, Astra Zeneca, Bristol-Myers, Eli Lilly, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, and Novartis. S. Takei has received grants from Bristol-Myers Squibb, Chugai, Eisai, and Takeda. Y. Sano and H. Yaguramaki are employees of Chugai. H. Yamanaka has received grants and speaking fees from Chugai. T. Koike, MD, Chief Executive, Sapporo Medical Center NTT EC, and Committee on Postmarketing Surveillance (PMS) of Japan College of Rheumatology; M. Harigai, MD, PhD, Professor, Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, and Committee on PMS of Japan College of Rheumatology; S. Inokuma, MD, Director, Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, and Committee on PMS of Japan College of Rheumatology; N. Ishiguro, MD, PhD, Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, and Committee on PMS of Japan College of Rheumatology; J. Ryu, MD, Nihon University, and Committee on PMS of Japan College of Rheumatology; T. Takeuchi, MD, PhD, Professor, Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, and Committee on PMS of Japan College of Rheumatology; S. Takei, MD, PhD, Professor, School of Health Sciences, Faculty of Medicine, Kagoshima University, and Committee on PMS of Japan College of Rheumatology; Y. Tanaka, MD, PhD, Professor, The First Department of Internal Medicine, University of Occupational and Environmental Health, and Committee on PMS of Japan College of Rheumatology; Y. Sano, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yaguramaki, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yamanaka, MD, Tokyo Women’s Medical University, and Committee on PMS of Japan College of Rheumatology. Address correspondence to Dr. T. Koike, Sapporo Medical Center NTT EC, S 1, W 15, Chuo Ku, Sapporo, Hokkaido, 060 0061, Japan. E-mail: tkoike@med.hokudai.ac.jp. Accepted for publication August 28, 2013.
Hisashi Yamanaka
From the Sapporo Medical Center NTT EC, Sapporo; Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, Tokyo; Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, Tokyo; Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Aichi; Nihon University, Tokyo; Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo; School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu; Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd., Tokyo; Tokyo Women’s Medical University, Tokyo; Committee on Postmarketing Surveillance of the Japan College of Rheumatology, Tokyo, Japan. Supported by Chugai Pharmaceutical Co. Ltd. T. Koike has received payment for lectures from Abbott, Astellas, Bristol Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe Pharma, Pfizer, Santen, Takeda, Taisyo-Toyama, Teijin, and UCS. M. Harigai has received research grants, speaking fees, or honoraria from Abbott, Astellas Pharma, Bristol-Myers Squibb, Chugai, Eisai Pharmaceuticals, Janssen Pharmaceuticals, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Takeda Pharmaceuticals, UCB Japan, and Pfizer; and has received consultant fees from Abbott, Bristol-Myers Squibb, Chugai, and Janssen Pharmaceuticals. N. Ishiguro has received grants and payment for lectures from Abbott, Chugai, Daiichi-Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer, and Takeda. T. Takeuchi has received research grants, travel funds, and payment for writing or reviewing a manuscript from Asahi Kasei Medical, Astra Zeneca, Bristol-Myers, Eli Lilly, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, and Novartis. S. Takei has received grants from Bristol-Myers Squibb, Chugai, Eisai, and Takeda. Y. Sano and H. Yaguramaki are employees of Chugai. H. Yamanaka has received grants and speaking fees from Chugai. T. Koike, MD, Chief Executive, Sapporo Medical Center NTT EC, and Committee on Postmarketing Surveillance (PMS) of Japan College of Rheumatology; M. Harigai, MD, PhD, Professor, Department of Pharmacovigilance, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, and Committee on PMS of Japan College of Rheumatology; S. Inokuma, MD, Director, Department of Allergy and Rheumatic Disease, Japanese Red Cross Medical Center, and Committee on PMS of Japan College of Rheumatology; N. Ishiguro, MD, PhD, Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, and Committee on PMS of Japan College of Rheumatology; J. Ryu, MD, Nihon University, and Committee on PMS of Japan College of Rheumatology; T. Takeuchi, MD, PhD, Professor, Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, School of Medicine, Keio University, and Committee on PMS of Japan College of Rheumatology; S. Takei, MD, PhD, Professor, School of Health Sciences, Faculty of Medicine, Kagoshima University, and Committee on PMS of Japan College of Rheumatology; Y. Tanaka, MD, PhD, Professor, The First Department of Internal Medicine, University of Occupational and Environmental Health, and Committee on PMS of Japan College of Rheumatology; Y. Sano, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yaguramaki, BS, Pharmacovigilance Department, Chugai Pharmaceutical Co. Ltd.; H. Yamanaka, MD, Tokyo Women’s Medical University, and Committee on PMS of Japan College of Rheumatology. Address correspondence to Dr. T. Koike, Sapporo Medical Center NTT EC, S 1, W 15, Chuo Ku, Sapporo, Hokkaido, 060 0061, Japan. E-mail: tkoike@med.hokudai.ac.jp. Accepted for publication August 28, 2013.
In this issue
The Journal of Rheumatology
Vol. 51, Issue 4
1 Apr 2024
Effectiveness and Safety of Tocilizumab: Postmarketing Surveillance of 7901 Patients with Rheumatoid Arthritis in Japan
Takao Koike, Masayoshi Harigai, Shigeko Inokuma, Naoki Ishiguro, Junnosuke Ryu, Tsutomu Takeuchi, Syuji Takei, Yoshiya Tanaka, Yoko Sano, Hitomi Yaguramaki, Hisashi Yamanaka
The Journal of Rheumatology Nov 2013, jrheum.130466; DOI: 10.3899/jrheum.130466
Effectiveness and Safety of Tocilizumab: Postmarketing Surveillance of 7901 Patients with Rheumatoid Arthritis in Japan
Takao Koike, Masayoshi Harigai, Shigeko Inokuma, Naoki Ishiguro, Junnosuke Ryu, Tsutomu Takeuchi, Syuji Takei, Yoshiya Tanaka, Yoko Sano, Hitomi Yaguramaki, Hisashi Yamanaka
The Journal of Rheumatology Nov 2013, jrheum.130466; DOI: 10.3899/jrheum.130466