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학술저널
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Toshifumi Hibi (Center for Advanced IBD Research and Treatment Kitasato University) Isao Kamae (Department of Health Policy and Technology Assessment Graduate School of Public Policy The Univers) Philippe Pinton (Japan Medical Office Takeda Pharmaceutical Company Limited) Lyann Ursos (Global Medical Affairs Takeda Pharmaceuticals USA Inc) Ryuichi Iwakiri (Japan Medical Office Takeda Pharmaceutical Company Limited) Greg Hather (Statistical & Quantitative Sciences Takeda Pharmaceuticals USA Inc.) Haridarshan Patel (Department of Evidence and Value Generation Global Medical Affairs Takeda Pharmaceuticals USA Inc)
저널정보
대한장연구학회 Intestinal research Intestinal research Vol.19 No.1
발행연도
2021.1
수록면
53 - 61 (9page)

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Background/Aims: Several biologic therapies are approved in Japan to treat moderately to severely active ulcerative colitis (UC), but there are no published comparative efficacy studies in a Japanese population. We compared the efficacy of biologics approved in Japan (adalimumab, infliximab, golimumab, and vedolizumab) for treating biologic-naïve patients with UC at their approved doses.Methods: A targeted literature review identified 4 randomized controlled trials of biologics for UC in biologicnaïve Japanese patients. For each study, efficacy outcome data from induction (weeks 6–12) and maintenance (weeks 30–60) treatment were extracted for analysis. Treatment effects on clinical response, clinical remission, and mucosal healing relative to the average placebo results across all trials were estimated using network meta-analyses followed by transformation into probabilities and odds ratios (OR).Results: At the end of induction, the likelihood of clinical response and clinical remission was highest with infliximab (OR: 2.12 and 2.35, respectively) and vedolizumab (OR: 2.10 and 2.32, respectively); the likelihood of mucosal healing was highest with infliximab (OR: 2.24) and adalimumab (OR: 1.86). During maintenance, the likelihood of clinical response and clinical remission was highest with vedolizumab (OR: 6.44 and 4.68, respectively) and golimumab (OR: 5.13 and 3.84, respectively); the likelihood of mucosal healing was significantly higher than placebo with all biologics.Conclusions: All active treatments were efficacious compared with placebo. Infliximab and vedolizumab had the highest odds for induction of clinical response, remission, and mucosal healing. Golimumab and vedolizumab had numerically higher odds of achieving efficacy outcomes in the maintenance phase.

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