1Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan
2Department of Health Policy and Technology Assessment, Graduate School of Public Policy, The University of Tokyo, Tokyo, Japan
3Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan
4Global Medical Affairs, Takeda Pharmaceuticals USA, Inc., Deerfield, IL, USA
5Statistical & Quantitative Sciences, Takeda Pharmaceuticals USA, Inc., Cambridge, MA, USA
6Department of Evidence and Value Generation, Global Medical Affairs, Takeda Pharmaceuticals USA, Inc., Deerfield, IL, USA
© Copyright 2021. Korean Association for the Study of Intestinal Diseases. All rights reserved.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Funding Source
This study was sponsored by Takeda.
Conflict of Interest
Hibi T has received grants from AbbVie, EA Pharmaceutical, JIMRO, Otsuka Holdings, and Zeria Pharmaceutical; lecture fees from Aspen Japan KK, AbbVie GK, Ferring, Gilead Sciences, Janssen, JIMRO, Kisse Pharmaceutical, Mitsubishi-Tanabe Pharmaceutical, Mochida Pharmaceutical, Nippon Kayaku, Pfizer, Takeda Pharmaceutical, and Zeria Pharmaceutical. Kamae I has received research grants from Takeda, Crecon Medical Assessment, Ono Pharmaceutical Co, Ltd, and Becton, Dickinson and Company Japan; traveling expense compensated by Takeda to attend the Takeda global advisory meeting (to Istanbul, once). Iwakiri R and Ursos L are employed by Takeda. Patel H was an employee of Takeda at the time the research was performed. Hather G and Pinton P are employed by and own stocks in Takeda. But, no other potential conflict of interest relevant to this article was reported.
Hibi T is an editorial board member of the journal but did not involve in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflicts of interest relevant to this article were reported.
Author Contribution
Study concept and design: Pinton P, Ursos L, Patel H. Literature review: Pinton P, Ursos L. Interpretation of data and adding clinical context: Hibi T, Kamae I, Pinton P, Ursos L, Iwakiri R, Hather G, Patel H. Drafting of the manuscript: Hibi T, Kamae I, Pinton P, Ursos L, Iwakiri R, Hather G, Patel H. All authors critically reviewed and revised the manuscript for important intellectual content and approved the final version of the manuscript before submission.
Non-Author Contribution
We thank Keith Chan of Precision Xtract (Vancouver, BC, Canada) for data analyses.
Author (year) | Study identifier | Study phase | Treatment phase | Study treatments | Sample size, n | Male sex (%) | Mean age (yr) | Mean disease duration (yr) | Mean score |
---|---|---|---|---|---|---|---|---|---|
Hibi et al. (2017) [16] | NCT01863771 (PURSUIT-J) | 3 | Maintenance | Placebo | 31 | 61 | 42.9 | 5.7a | 8.0a |
Golimumab (SC) 100 mg Q4W | 32 | 59 | 39.3 | 5.4a | 8.0a | ||||
Kobayashi et al. (2016) [17] | Japic CTI-060298 | 3 | Induction | Placebo | 104 | 64 | 37.8 | 7.1 | 8.5 |
Infliximab (IV) 5 mg/kg wk 0, 2, 6 | 104 | 63 | 40.0 | 8.1 | 8.6 | ||||
Maintenance | Placebo | 72 | NA | NA | NA | NA | |||
Infliximab (IV) 5 mg/kg wk 14, 22 | 73 | NA | NA | NA | NA | ||||
Suzuki et al. (2014) [19] | NCT00853099 | 2/3 | Induction | Placebo | 96 | 73 | 41.3 | 7.8 | 8.5 |
Adalimumab (SC) 160 mg wk 0, 80 mg wk 2 | 90 | 68 | 42.5 | 7.8 | 8.6 | ||||
Maintenance | Placebo | 96 | 73 | 41.3 | 7.8 | 8.5 | |||
Adalimumab (SC) 40 mg Q2W | 177 | 63 | 43.4 | 8.0 | 8.6 | ||||
Motoya et al. (2019) [18] | NCT02039505 | 3 | Induction | Placebo | 82 | 67 | 44.0 | 8.6 | 8.1 |
Vedolizumab (IV) 300 mg wk 0, 2, 6 | 164 | 60 | 42.3 | 7.2 | 8.3 | ||||
Maintenance | Placebo | 42 | 55 | 42.6 | 8.7 | 7.9 | |||
Vedolizumab (IV) 300 mg Q8W | 41 | 51 | 43.0 | 8.6 | 8.1 |
Author (year) | Study identifier | Study phase | Treatment phase | Study treatments | Sample size, n | Male sex (%) | Mean age (yr) | Mean disease duration (yr) | Mean score |
---|---|---|---|---|---|---|---|---|---|
Hibi et al. (2017) [16] | NCT01863771 (PURSUIT-J) | 3 | Maintenance | Placebo | 31 | 61 | 42.9 | 5.7 |
8.0 |
Golimumab (SC) 100 mg Q4W | 32 | 59 | 39.3 | 5.4 |
8.0 |
||||
Kobayashi et al. (2016) [17] | Japic CTI-060298 | 3 | Induction | Placebo | 104 | 64 | 37.8 | 7.1 | 8.5 |
Infliximab (IV) 5 mg/kg wk 0, 2, 6 | 104 | 63 | 40.0 | 8.1 | 8.6 | ||||
Maintenance | Placebo | 72 | NA | NA | NA | NA | |||
Infliximab (IV) 5 mg/kg wk 14, 22 | 73 | NA | NA | NA | NA | ||||
Suzuki et al. (2014) [19] | NCT00853099 | 2/3 | Induction | Placebo | 96 | 73 | 41.3 | 7.8 | 8.5 |
Adalimumab (SC) 160 mg wk 0, 80 mg wk 2 | 90 | 68 | 42.5 | 7.8 | 8.6 | ||||
Maintenance | Placebo | 96 | 73 | 41.3 | 7.8 | 8.5 | |||
Adalimumab (SC) 40 mg Q2W | 177 | 63 | 43.4 | 8.0 | 8.6 | ||||
Motoya et al. (2019) [18] | NCT02039505 | 3 | Induction | Placebo | 82 | 67 | 44.0 | 8.6 | 8.1 |
Vedolizumab (IV) 300 mg wk 0, 2, 6 | 164 | 60 | 42.3 | 7.2 | 8.3 | ||||
Maintenance | Placebo | 42 | 55 | 42.6 | 8.7 | 7.9 | |||
Vedolizumab (IV) 300 mg Q8W | 41 | 51 | 43.0 | 8.6 | 8.1 |
Induction phase treatment | Clinical response |
Clinical remission |
Mucosal healing |
|||
---|---|---|---|---|---|---|
Probability, % (95% CrI) | RD, % (95% CrI) | Probability, % (95% CrI) | RD, % (95% CrI) | Probability, % (95% CrI) | RD, % (95% CrI) | |
Placebo | 0.37 (0.31 to 0.43) | Reference | 0.11 (0.08 to 0.15) | Reference | 0.30 (0.24 to 0.36) | Reference |
Adalimumab 160/80 mg | 0.46 (0.34 to 0.59) | 0.09 (–0.04 to 0.23) | 0.16 (0.09 to 0.25) | 0.05 (–0.02 to 0.14) | 0.44 (0.31 to 0.58) | 0.14 (0.00 to 0.29) |
Infliximab 5 mg/kg | 0.55 (0.43 to 0.67) | 0.18 (0.06 to 0.30) | 0.22 (0.14 to 0.32) | 0.11 (0.03 to 0.21) | 0.49 (0.35 to 0.62) | 0.19 (0.05 to 0.33) |
Vedolizumab 300 mg | 0.55 (0.40 to 0.70) | 0.18 (0.01 to 0.35) | 0.22 (0.12 to 0.35) | 0.11 (0.01 to 0.25) | 0.46 (0.31 to 0.63) | 0.16 (–0.02 to 0.36) |
Sustained clinical response |
Sustained clinical remission |
Mucosal healing |
||||
Probability, % (95% CrI) | RD, % (95% CrI) | Probability, % (95% CrI) | RD, % (95% CrI) | Probability, % (95% CrI) | RD, % (95% CrI) | |
Placebo | 0.09 (0.05 to 0.15) | Reference | 0.03 (0.01 to 0.06) | Reference | 0.11 (0.06 to 0.17) | Reference |
Adalimumab 40 mg | 0.15 (0.06 to 0.30) | 0.06 (–0.03 to 0.21) | 0.06 (0.02 to 0.15) | 0.06 (–0.02 to 0.11) | 0.21 (0.10 to 0.36) | 0.10 (0.02 to 0.23) |
Golimumab 100 mg | 0.34 (0.17 to 0.58) | 0.25 (0.06 to 0.51) | 0.18 (0.07 to 0.38) | 0.14 (0.03 to 0.35) | 0.60 (0.27 to 0.91) | 0.49 (0.13 to 0.85) |
Infliximab 5 mg/kg | NA | NA | NA | NA | 0.21 (0.10 to 0.36) | 0.10 (0.02 to 0.22) |
Vedolizumab 300 mg | 0.28 (0.13 to 0.47) | 0.18 (0.04 to 0.38) | 0.13 (0.05 to 0.28) | 0.10 (0.02 to 0.24) | 0.31 (0.14 to 0.56) | 0.20 (0.04 to 0.46) |
Values expressed as median. SC, subcutaneous; IV, intravenous; Q2W, every 2 weeks; Q4W, every 4 weeks; Q8W, every 8 weeks; NA, not available.
RD, risk difference; CrI, credible intervals; NA, not available.