Intest Res.  2021 Jan;19(1):53-61. 10.5217/ir.2019.09146.

Efficacy of biologic therapies for biologic-naïve Japanese patients with moderately to severely active ulcerative colitis: a network meta-analysis

• Hibi T
• Kamae I
• Pinton P
• Ursos L
• Iwakiri R
• Hather G
• Patel H

• KMID: 2512101
• DOI: http://doi.org/10.5217/ir.2019.09146

Abstract

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.

Keyword

Biologics; Colitis, ulcerative; Network meta-analysis; Efficacy

Figure

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  Fig. 1. Evidence structure of eligible comparisons for network meta-analysis. (A) Induction phase: response, remission, and mucosal healing (3 studies and 3 active treatments). (B) Maintenance phase: sustained response and sustained remission (3 studies and 3 active treatments). (C) Maintenance phase: mucosal healing (4 studies and 4 active treatments).

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  Fig. 2. Odds of efficacy outcomes with active treatments versus placebo. (A) Clinical response in induction and sustained response in maintenance. (B) Clinical remission in induction and sustained remission in maintenance. (C) Mucosal healing in induction and maintenance. OR, odds ratio; CrI, credible intervals.

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