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

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.

A Draft of Socio-economic Evaluation Guideline for Pharmaceuticals and Medical Devices Based on Japanese Experts Consensus: Potentials and Issues / 薬剤疫学

The interest has been officially growing in introducing health economics approach to the issues of pricing and reimbursement for new drugs and medical devices. In the Social Security Reform Plan of the Cabinet Office, the Ministry of Health, Labor, and Welfare proposed an idea for further investigating a role of socio-economic evaluation to assess the innovation of medical technology. To address this new circumstance, the government must develop and implement an official guideline for economic evaluation of medical technology. Responding to the emerging need for a socio-economic evaluation guideline, we illuminate an outline of the socio-economic evaluation guideline drafted by experts' consensus and proposed to Ministry of Health, Labor, and Welfare in March 2007. Also the potentials and the issues to substantiate the guideline by government were identified for future discussions between government, academics and industry.