Takeuchi, Tsutomu
Nishikawa, Kiyohiro http://orcid.org/0000-0003-2350-6189
Yamada, Fumika
Morita, Akimichi
Ohtsuki, Mamitaro
Suzuki, Yasuo
Watanabe, Mamoru
Yamanaka, Hisashi
Hibi, Toshifumi
Funding for this research was provided by:
Nippon Kayaku
Article History
Accepted: 26 July 2023
First Online: 12 September 2023
Declarations
:
: This integrated analysis and included three Japanese post-marketing surveillances were sponsored by Nippon Kayaku Co., Ltd. (Tokyo, Japan).
: Tsutomu Takeuchi has received grants from AbbVie, Asahi Kasei Pharma, Ayumi Pharmaceutical, Boehringer-Ingelheim, Chugai Pharmaceutical, Daiichi Sankyo, DNA Chip Research, Eisai, Eli Lilly Japan, Mitsubishi Tanabe Pharma, Nippon Kayaku, Ono Pharmaceutical, and UCB Japan; consulting fees from AbbVie, Astellas Pharma, Chugai Pharmaceutical, Eli Lilly Japan, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, Novartis Pharma, Pfizer, and Taisho Pharmaceutical; and speaker fees from AbbVie, Astellas Pharma, AstraZeneca, Ayumi Pharmaceutical, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Eli Lilly Japan, Gilead Sciences, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, Novartis Pharma, Pfizer, Sanofi, Taisho Pharmaceutical, and UCB Japan. Kiyohiro Nishikawa was an employee of and holds stocks in Nippon Kayaku. Fumika Yamada is an employee of Nippon Kayaku. Akimichi Morita has received research grants from AbbVie, Eisai, Eli Lilly Japan, Janssen Pharmaceutical, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Novartis, Sun Pharma Japan, Taiho Pharmaceutical, Torii Pharmaceutical, and Ushio; consulting fees from Amgen, Bristol Myers Squibb, Eli Lilly Japan, Janssen Pharmaceutical, Minophagen Pharmaceutical, Nippon Boehringer Ingelheim, Nippon Kayaku, and UCB Japan; and speaker fees from AbbVie, Amgen, Bristol Myers Squibb, Eisai, Eli Lilly Japan, Janssen Pharmaceutical, Kyowa Kirin, Maruho, Minophagen Pharmaceutical, Nippon Boehringer Ingelheim, Novartis, Sun Pharma Japan, Taiho Pharmaceutical, UCB Japan, and Ushio. Mamitaro Ohtsuki has received research grants from AbbVie, Eisai, Kyowa Kirin, Maruho, Mitsubishi Tanabe Pharma, Sun Pharma Japan, Taiho Pharmaceutical, and Torii Pharmaceutical; consulting fees from Bristol Myers Squibb, Eli Lilly Japan, LEO Pharma, Nippon Boehringer Ingelheim, Nippon Kayaku, Novartis, and UCB Japan; and speaker fees from AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly Japan, Janssen Pharmaceutical, Kyowa Kirin, LEO Pharma, Maruho, Sanofi, Taiho Pharmaceutical, Torii Pharmaceutical, and UCB Japan. Yasuo Suzuki has received grants from AbbVie, EA Pharma, JIMRO, Kissei Pharmaceutical, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, and Nippon Kayaku; and speaker fees from AbbVie, EA Pharma, Janssen Pharmaceutical, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Takeda Pharmaceutical, and Zeria Pharmaceutical. Mamoru Watanabe has received research funding from AbbVie, EA Pharma, Kissei Pharmaceutical, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Nippon Kayaku, Takeda Pharmaceutical, and Zeria Pharmaceutical; consultancy fees from AbbVie, EA Pharma, Eli Lilly Japan, Gilead Sciences, Kissei Pharmaceutical, Nichi-Iko Pharmaceutical, and Nippon Boehringer Ingelheim; and lecture fees from AbbVie, EA Pharma, Eli Lilly Japan, Gilead Sciences, Janssen Pharmaceutical, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Nippon Boehringer Ingelheim, Takeda Pharmaceutical, and Zeria Pharmaceutical. Hisashi Yamanaka has received consulting fees from AbbVie, Chugai Pharmaceutical, CorEvitas, Nippon Kayaku, Pfizer, Sato Pharmaceutical, Teijin Pharma, and YL Biologics; and speaker fees from AbbVie, Asahi Kasei Pharma, Ayumi Pharmaceutical, Bristol Meyers Squibb, Chugai Pharmaceutical, Eli Lilly Japan, Fuji Yakuhin, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Pfizer, Teijin Pharma, and YL Biologics. Toshifumi Hibi has received research grants or scholarship contributions from AbbVie, Activaid, Alfresa Pharma, Bristol Myers Squibb, Eli Lilly Japan, Ferring Pharmaceuticals, Gilead Sciences, Janssen Pharmaceutical, JMDA, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kayaku, Pfizer, Takeda Pharmaceutical, and Zeria Pharmaceutical; advisory/consultancy fees from AbbVie, Celltrion, EA Pharma, Eli Lilly Japan, Gilead Sciences, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, Nichi-Iko Pharmaceutical, Nippon Kayaku, Takeda Pharmaceutical, and Zeria Pharmaceutical; and lecture fees from AbbVie, EA Pharma, Janssen Pharmaceutical, JIMRO, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Pfizer, Sandoz, Takeda Pharmaceutical, and Zeria Pharmaceutical.
: The protocols of the PMSs were submitted to and approved by the Ministry of Health, Labour and Welfare. The protocol and ethical considerations of the PMS were reviewed and approved by internal review board members (approval numbers for PMSs in patients with rheumatoid arthritis, inflammatory bowel disease, and psoriasis are 20130717, 20140807, and 20150605, respectively) and/or independent ethics committee at each medical institutions participating in the PMS.
: The PMS was conducted in accordance with the Good Post-marketing Study Practice Ordinance of the Ministry of Health, Labour and Welfare, and informed consent from individual patients was not required.
: Not applicable.
: The datasets generated during the current study are available from Nippon Kayaku on reasonable request (ExternalRef removed).
: Not applicable.
: All named authors meet the International Committee of Medical Journal Editors (ICMJE) authorship criteria for this article, and take responsibility for the integrity of the work. TT, KN, FY, AM, MO, and TH contributed to the study conceptualization and methodology. FY, AM, MO, YS, MW, HY, and TH collected data, which were analyzed and validated by KN and FY. The manuscript was drafted by KN, and critically reviewed by TT, FY, MW, HY, and TH. All authors read and approved the final manuscript.