胃腸内科におけるバイオシミラーの有効性と安全性:炎症性腸疾患の管理に重点を置く
Fruzsina Balogh1,2, Dorottya Angyal2, Adam Varga1
1Department of Gastroenterology, Central Hospital of Northern Pest-Military Hospital, Budapest, Hungary.
Expert opinion on biological therapy
|September 5, 2025
まとめ
インフリキシマブ,アダリムマブ,ウステキヌマブのバイオシミラーは,炎症性腸疾患 (IBD) の管理において,比較可能な有効性と安全性を提供します. バイオセラピーへのアクセスを改善し,コストを削減し,安全性が証明されています.
科学分野:
- 胃腸内科と免疫学
- 薬学経済と薬物開発
背景:
- バイオシミラーは,インフリキシマブバイオシミラーの導入以来,炎症性腸疾患 (IBD) の治療に変化をもたらしました.
- バイオシミラー薬の有効性と安全性は基準の生物学的薬と同等であり,患者へのアクセスを改善し,コストを下げるという証拠があります.
研究 の 目的:
- IBDにおける承認されたインフリキシマブ,アダリムマブ,ウステキヌマブバイオシミラーに関する現在の証拠をレビューする.
- 薬剤の持続性,有効性,安全性,免疫性,およびバイオシミラー剤の互換性に関するデータを分析する.
主な方法:
- IBDにおけるバイオシミラーに関する臨床試験と実用研究の体系的レビュー.
- 非医学的スイッチングと比較効果に関するデータの分析.
主要な成果:
- インフリキシマブとアダリムマブのバイオシミラーは,オリジナルの製品と比較可能な安全性,有効性,免疫性を示しています.
- IBD患者では,原薬からバイオシミラー,またはバイオシミラー間の切り替えが安全であることが示されています.
結論:
- バイオシミラルの採用により,IBDにおける生物学的薬剤の利用が成功しました.
- バイオシミラーによる長期的な価格競争は有益ですが,新しい原産生物学的薬の開発に課題をもたらす可能性があります.
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