Darvadstrocel for Complex Perianal Fistulas in Japanese Adults with Crohn's Disease: A Phase 3 Study.

"Conflict of Interest SF receives honoraria from Takeda Pharmaceutical and AbbVie. TM receives an honorarium from Takeda Pharmaceutical and research grants from Takeda Pharmaceutical, Kaken Pharmaceutical, Taiho Pharmaceutical, Sanofi, Chugai Pharmaceutical, Astellas Pharma, Shionogi, Mitsubishi Tanabe Pharma, Yakult Honsha, Bayer AG, Daiichi Sankyo, EA Pharma, Eli Lilly, and MSD, and the Department of Therapeutics for Inflammatory Bowel Diseases, Osaka University Graduate School of Medicine is supported by an unrestricted grant from Kinshukai Medical Corporation. RN, MS, and TY are current employees of Takeda Pharmaceutical. KW receives honoraria from AbbVie Japan, Mitsubishi Tanabe Pharma, EA Pharma, Takeda Pharmaceutical, Kyorin Pharmaceutical, Mochida Pharmaceutical, Janssen Pharmaceutical, Pfizer Japan, and Kissei Pharmaceutical. KW also receives grants including consigned/joint research expenses, scholarship donations, and course affiliations from EA Pharma, Takeda Pharmaceutical, AbbVie Japan, Astellas Pharma, Zeria Pharmaceutical, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, JIMRO, Otsuka Pharmaceutical, Asahi Kasei Medical, and Mochida Pharmaceutical. KF receives honoraria from Takeda Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, AbbVie, and Kyorin Pharmaceutical. KF also receives research grants from Takeda Pharmaceutical."

"Funding This work was supported by Takeda Pharmaceutical Company Limited. The sponsor assisted with designing the study and supported on data collection, analysis, and interpretation. Medical writing assistance was provided by Aisling O’Keeffe, Mittal Makhija, and Mie Yamamoto of MIMS Co Ltd, sponsored by Takeda, in compliance with Good Publication Practice 3 ethical guidelines [Battisti et al., Ann Intern Med 2015;163:461–4]."

"This is an ongoing phase 3, multicentre, open-label, uncontrolled study at nine sites in Japan [ClinicalTrials.gov number: NCT03706456], designed to evaluate the efficacy and safety of darvadstrocel for the treatment of complex perianal fistulas in adult Japanese patients with CD. The design of this study is similar to that of the ADMIRE-CD study except that this is an open-label, single-arm study.,"