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瑞士多发性硬化症队列中开始使用B细胞耗竭疗法的患者的治疗持续性和临床结局

Treatment persistence and clinical outcomes in patients starting B cell depleting therapies within the Swiss MS Cohort.

作者信息

Disanto Giulio, Schaedelin Sabine, Oechtering Johanna, Lorscheider Johannes, Galbusera Riccardo, Finkener Sebastian, Achtnichts Lutz, Lalive Patrice, Müller Stefanie, Pot Caroline, Hoepner Robert, Salmen Anke, Zecca Chiara, Hemkens Lars G, D'Souza Marcus, Fischer-Barnicol Bettina, Du Pasquier Renaud, Roth Patrick, Yaldizli Özgür, Einsiedler Maximilian, Derfuss Tobias, Kappos Ludwig, Gobbi Claudio, Granziera Cristina, Uginet Marjolaine, Maceski Aleksandra Maleska, McDonald Keltie, Leppert David, Benkert Pascal, Kuhle Jens

机构信息

Multiple Sclerosis Center, Department of Neurology, Neurocenter of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, Switzerland.

Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland.

出版信息

Mult Scler J Exp Transl Clin. 2025 Feb 26;11(1):20552173251315457. doi: 10.1177/20552173251315457. eCollection 2025 Jan-Mar.

Abstract

BACKGROUND

Persistence to B cell depleting therapies (BCDT) like ocrelizumab and rituximab may be higher compared with other disease-modifying therapies (DMT) in multiple sclerosis (MS). Clinical trials directly comparing these treatments are lacking.

OBJECTIVE

To compare the risk of treatment discontinuation, relapse, and confirmed disability worsening in patients starting BCDT vs other DMT within real-world settings.

METHODS

In a longitudinal cohort study, patients with relapsing MS starting BCDT (ocrelizumab/rituximab,  = 269) after enrolment into the Swiss MS Cohort (SMSC) were evaluated for treatment discontinuation, occurrence of relapses, and disability worsening in comparison with platform ( = 57) and oral ( = 454) DMT, or natalizumab ( = 73) using Cox regression with double robust adjustment for baseline covariates.

RESULTS

Patients starting BCDT were less likely to discontinue treatment than all other DMT combined (HR = 0.26, 95% CI = 0.18-0.36,  < .01), oral DMT (HR = 0.28, 95% CI = 0.20-0.39,  < .01) and natalizumab (HR = 0.35, 95% CI = 0.21-0.58,  < .01). BCDT were associated with lower risk of relapses as compared to oral DMT HR = 0.59, 95% CI = 0.39-0.88,  < .01), but not to natalizumab (HR = 0.90, 95% CI = 0.45-1.82,  = .778). Disability worsening was not significantly different between treatment groups.

CONCLUSION

We provide real-world evidence for patients being more persistent to BCDT than to other treatments, and better clinical outcomes may partly explain this.

摘要

背景

与多发性硬化症(MS)中的其他疾病改善疗法(DMT)相比,患者对奥瑞珠单抗和利妥昔单抗等B细胞耗竭疗法(BCDT)的持久性可能更高。缺乏直接比较这些治疗方法的临床试验。

目的

比较在现实环境中开始使用BCDT与其他DMT的患者停药、复发和确诊残疾恶化的风险。

方法

在一项纵向队列研究中,纳入瑞士MS队列(SMSC)后开始使用BCDT(奥瑞珠单抗/利妥昔单抗,n = 269)的复发型MS患者,与平台型(n = 57)和口服型(n = 454)DMT或那他珠单抗(n = 73)相比,通过对基线协变量进行双重稳健调整的Cox回归评估治疗停药、复发情况和残疾恶化情况。

结果

开始使用BCDT的患者比所有其他DMT联合使用(HR = 0.26,95%CI = 0.18 - 0.36,P <.01)、口服DMT(HR = 0.28,95%CI = 0.20 - 0.39,P <.01)和那他珠单抗(HR = 0.35,95%CI = 0.21 - 0.58,P <.01)更不容易停药。与口服DMT相比,BCDT与较低的复发风险相关(HR = 0.59,95%CI = 0.39 - 0.88,P <.01),但与那他珠单抗无关(HR = 0.90,95%CI = 0.45 - 1.82,P = 0.778)。治疗组之间残疾恶化情况无显著差异。

结论

我们提供了现实世界的证据,表明患者对BCDT的持久性高于其他治疗方法,更好的临床结果可能部分解释了这一点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/62bc/11866361/9d32c4c7ef67/10.1177_20552173251315457-fig1.jpg

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