再発性多発性硬化症におけるオクレリズマブのリアルワールド有効性：MSBaseレジストリのサブスタディ
Helmut Butzkueven1, Pamela Farr2, Serkan Ozakbas3
1Department of Neuroscience, School of Translational Medicine, Monash University, Melbourne, Australia; MSBase Foundation, Alfred Centre, Melbourne, Australia.
Multiple sclerosis and related disorders
|December 20, 2025
まとめ
オクレリズマブ（OCR）は、リアルワールドの設定において、再発性多発性硬化症（RMS）患者に対して長期的に顕著な有効性を示しました。本研究では、再発の減少と障害進行の抑制が観察され、治療の持続性も高いことが示されました。
科学分野:
- 神経学;免疫学;臨床試験
背景:
- オクレリズマブ（OCR）は、再発性多発性硬化症（RMS）の標的療法です。;臨床試験を超えた長期的な治療効果を理解するためには、リアルワールドデータが不可欠です。
研究 の 目的:
- 再発性多発性硬化症（RMS）患者のリアルワールドコホートにおけるオクレリズマブ（OCR）の長期的な有効性と安全性を評価すること。;障害悪化、疾患進行、および疾患活動性なし（NEDA-3）を含む転帰を評価すること。
主な方法:
- 国際MSBaseレジストリを用いた前向き、縦断的、観察的コホート研究（MSOCR-R）。;OCRで新規治療を受けたRMS患者1011人を対象としました。;中央値3.4年の追跡期間における、確認された障害悪化（CDW）、再発に依存しない進行（PIRA）、およびNEDA-3を分析しました。
主要な成果:
- 24週CDWおよびPIRAの4年確率はそれぞれ25.2%、21.9%でした。;OCR開始後の年間再発率は0.58から0.05へと有意に減少しました。;4年時点でNEDA-3を達成したのは39.7%で、治療持続率は88.0%でした。
結論:
- オクレリズマブは、再発性多発性硬化症の管理において、強力なリアルワールド有効性を示しました。;OCRの一次治療は、優れた臨床転帰と関連していました。;本研究結果は、OCRがRMS患者にとって価値のある治療選択肢であることを支持します。
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