Axhausen Franziska, Mrochen Anne, Winter Pia, Baumgart Romy, Mühlenbrock Pauline, Mück Anna, Wolff Stephanie, Meuth Sven G, Möllenhoff Kathrin, Pfeuffer Steffen
Department of Neurology, University Hospital Giessen and Marburg, Justus-Liebig-University Giessen, Giessen, Germany.
Department of Neurology, University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf, Dusseldorf, Germany.
Mult Scler. 2025 Aug;31(9):1110-1120. doi: 10.1177/13524585251361330. Epub 2025 Jul 30.
Ocrelizumab (OCR) and ofatumumab (OFA)are approved and their differences in dosing route and interval allow personalized treatment. However, there are no data on whether lateral switches between both substances affect treatment effectiveness or safety.
We screened our local cohort of MS patients, who began OCR since 09/2020 or OFA since 09/2021. Patients with a lateral switch were matched to controls who continuously received initial B-cell depleting therapy (BCT). We compared disease courses including effectiveness outcomes as well as peripheral CD19+ B-cell counts and serum IgG levels.
From 09/2020 to 03/2024, 713 patients were subjected to BCT (OCR: 396; OFA: 317 [as in Fig.1]). The matched OCR cohort included 38 switchers and 149 controls. The OFA cohort consisted of 24 switchers and 83 controls. Effectiveness outcomes were comparable among switchers and controls. B cell depletion appeared slightly pronounced following a switch. Serum IgG levels declined faster among switchers compared to controls (OCR: 9.7 vs 9.0 g/L; = ; manifest hypogammaglobulinemia (HGG) in 13.2% vs 6.0%; OFA: 9.7 vs 8.4 g/L; = ; manifest HGG in 8.3% vs 2.4%).
Lateral switching between BCT does not abate effectiveness in this matched real-world cohort. Our observation of increased loss of IgG warrants further validation, but may indicate niche-specific immunological effects of OFA and OCR.
奥瑞珠单抗（OCR）和奥法妥木单抗（OFA）已获批准，它们在给药途径和间隔上的差异允许进行个性化治疗。然而，关于这两种药物之间的横向转换是否会影响治疗效果或安全性，尚无相关数据。
我们筛选了本地的多发性硬化症（MS）患者队列，这些患者自2020年9月起开始使用OCR或自2021年9月起开始使用OFA。横向转换的患者与持续接受初始B细胞清除疗法（BCT）的对照组进行匹配。我们比较了疾病进程，包括疗效结果以及外周血CD19 + B细胞计数和血清IgG水平。
从2020年9月到2024年3月，713例患者接受了BCT（OCR：396例；OFA：317例[如图1所示]）。匹配的OCR队列包括38例转换者和149例对照组。OFA队列由24例转换者和83例对照组组成。转换者和对照组之间的疗效结果相当。转换后B细胞清除似乎略有明显。与对照组相比，转换者的血清IgG水平下降更快（OCR：9.7 vs 9.0 g/L；P = ；明显低丙种球蛋白血症（HGG）发生率为13.2% vs 6.0%；OFA：9.7 vs 8.4 g/L；P = ；明显HGG发生率为8.3% vs 2.4%）。
在这个匹配的真实世界队列中，BCT之间的横向转换不会降低疗效。我们观察到IgG损失增加值得进一步验证，但可能表明OFA和OCR具有特定的免疫效应。
