Multiple Disease-Modifying Antirheumatic Drugs Combination Therapy with Methotrexate in Rheumatoid Arthritis: A Systematic Review and Bayesian Network Meta-Analysis of Efficacy and Safety

2023 Fiscal Year Final Research Report

• Project/Area Number: 21K06647
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 47060:Clinical pharmacy-related
• Research Institution: Nagoya City University
• Principal Investigator: Tohkin Masahiro 名古屋市立大学, 医薬学総合研究院(薬学), 教授 (00270629)
• Project Period (FY): 2021-04-01 – 2024-03-31
• Keywords: システマティック・レビュー / 疾患修飾性抗リウマチ薬 / 臨床試験 / ネットワークメタ解析

Outline of Final Research Achievements

The combination therapies of biological disease-modifying antirheumatic drugs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) plus methotrexate (MTX) is recommended for the treatment of rheumatoid arthritis (RA). We employed to assess the efficacy and safety of combination therapy through network meta-analysis, with the aim of ranking the efficacy and safety of various b/tsDMARDs+MTX combination therapies. The primary efficacy outcome was the 50% improvement rate according to the American College of Rheumatology (ACR50) criteria. The primary safety outcome was the incidence of serious adverse events. Individually, Infliximab combined with MTX had the highest efficacy ranking, while Etanercept combined with MTX had the highest safety ranking. Cluster analysis of efficacy and safety revealed that the combination of Etanercept, an Fc-fusion protein targeting TNF-α, with MTX demonstrated both high efficacy and safety.

Free Research Field

レギュラトリーサイエンス

Academic Significance and Societal Importance of the Research Achievements

総合評価の結果、エタネルセプト+MTXの併用治療が各評価項目に共通して高い指標を示し、相対的な順位付けにおいて上位となった。このことから、エタネルセプトのMTX併用療法は有効性と安全性の両方の観点から有用性の高い治療法である可能性が示唆された。本研究の成果は、リウマチ治療の臨床現場での薬剤選択の重要な参考資料になると考えられる。今後は実臨床での治療成績等の、いわゆるリアルワールドデータを用いた解析の結果と本研究の成果の両方を考慮することで、より臨床現場に役立つ情報が提供できるものと考えられる。