The authors wish to acknowledge the contributions of the late Professor Kazuhiko Inoue, MD, PhD, who participated in this work. The authors also wish to thank all participating physicians and registered patients. The Etanercept Post-Marketing Surveillance Committee of the Japan College of Rheumatology was created in response to a request for assistance from the Ministry of Health, Labor, and Welfare (MHLW) of Japan. The role of the committee is to provide independent advice to Wyeth K. K. (Wyeth was integrated into Pfizer in October 2009) on the conduct of the Post-Marketing Surveillance Program mandated by the MHLW and on the results thereof. Participation on this committee is not compensated. The authors wish to thank John E. Fincke, PhD, and Susan DeRocco, PhD, whose work was funded by Wyeth Research, for providing assistance in the drafting of this manuscript. This study was sponsored by Wyeth, and clinical fees were shared by Wyeth K. K. (Wyeth was integrated into Pfizer in October 2009) and Takeda Pharmaceutical Company Limited, Wyeth K. K.’s copromotion partner for etanercept in Japan.
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 Tanabe Pharma, 3; Takeda Pharmaceutical Co. Ltd, 3; H. Yamanaka, Abbott Japan, 1; Chugai Pharmaceutical Co. Ltd, 1; Eisai Co. Ltd, 1; Mitsubishi Tanabe Pharma, 1; Takeda Pharmaceutical Co. Ltd, 1; Wyeth KK, 1; Abbott Japan, 3; Chugai Pharmaceutical Co. Ltd, 3; Eisai Co. Ltd, 3; Mitsubishi Tanabe Pharma, 3; Pfizer Japan Inc., 3; Takeda Pharmaceutical Co. Ltd, 3; Wyeth KK, 3; B. Freundlich, Pfizer Inc., 5; K. Fujii, Pfizer Japan Inc., 4; T. Yoshinaga, Pfizer Japan Inc., 4; M. Suzukawa, Pfizer Japan Inc., 4.