Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II

被引：62

作者：

Gaertner, Jutta ^{[6
]}

Hauser, Stephen L. ^{[7
]}

Bar-Or, Amit ^{[8
,9
]}

Montalban, Xavier ^{[10
]}

Cohen, Jeffrey A. ^{[11
]}

Cross, Anne H. ^{[12
]}

Deiva, Kumaran ^{[13
]}

Ganjgahi, Habib ^{[14
,15
]}

Haering, Dieter A. ^{[16
]}

Li, Bingbing ^{[17
]}

Pingili, Ratnakar ^{[17
]}

Ramanathan, Krishnan ^{[16
]}

Su, Wendy ^{[17
]}

Willi, Roman ^{[16
]}

Kieseier, Bernd ^{[16
]}

Kappos, Ludwig ^{[1
,2
,3
,4
,5
]}

机构：

[1] Univ Basel, Univ Hosp Basel, Res Ctr Clin Neuroimmunol & Neurosci Basel RC2NB, Petersgraben 4, CH-4031 Basel, Switzerland

[2] Univ Basel, Univ Hosp Basel, MS Ctr, Petersgraben 4, CH-4031 Basel, Switzerland

[3] Univ Basel, Univ Hosp Basel, Dept Med, Petersgraben 4, CH-4031 Basel, Switzerland

[4] Univ Basel, Univ Hosp Basel, Dept Clin Res, Petersgraben 4, CH-4031 Basel, Switzerland

[5] Univ Basel, Univ Hosp Basel, Dept Biomed & Biomed Engn, Petersgraben 4, CH-4031 Basel, Switzerland

[6] Georg August Univ Gottingen, Univ Med Ctr Gottingen, Dept Paediat & Adolescent Med, Div Paediat Neurol, Gottingen, Germany

[7] Univ Calif San Francisco, Dept Neurol, UCSF Weill Inst Neurosci, San Francisco, CA 94143 USA

[8] Univ Penn, Ctr Neuroinflammat & Expt Therapeut, Perelman Sch Med, Philadelphia, PA 19104 USA

[9] Univ Penn, Dept Neurol, Perelman Sch Med, Philadelphia, PA 19104 USA

[10] Hosp Univ Vall dHebron, Ctr Esclerosi Multiple Catalunya Cemcat, Dept Neurol Neuroimmunol, Barcelona, Spain

[11] Cleveland Clin, Neurol Inst, Dept Neurol, Mellen MS Ctr, Cleveland, OH 44106 USA

[12] Washington Univ, Sch Med, Dept Neurol, Sect Neuroimmunol, St Louis, MO 63110 USA

[13] Univ Hosp Paris Saclay, Natl Reference Ctr Rare Inflammatory Brain & Spin, Dept Pediat Neurol, Hop Bicetre, Le Kremlin Bicetre, France

[14] Univ Oxford, Nuffield Dept Populat Hlth, Oxford Big Data Inst, Li Ka Shing Ctr Hlth Informat & Discovery, Oxford, England

[15] Univ Oxford, Stat Dept, Oxford, England

[16] Novartis Pharma AG, Basel, Switzerland

[17] Novartis Pharmaceut, E Hanover, NJ USA

来源：

MULTIPLE SCLEROSIS JOURNAL | 2022年 / 28卷 / 10期

关键词：

Relapsing multiple sclerosis; recently diagnosed; treatment-naive; progression independent of relapse activity; no evidence of disease activity; neurofilament light chain; BRAIN VOLUME LOSS; ATROPHY; MRI;

D O I：

10.1177/13524585221078825

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Background: In the phase III ASCLEPIOS I and II trials, participants with relapsing multiple sclerosis receiving ofatumumab had significantly better clinical and magnetic resonance imaging (MRI) outcomes than those receiving teriflunomide. Objectives: To assess the efficacy and safety of ofatumumab versus teriflunomide in recently diagnosed, treatment-naive (RDTN) participants from ASCLEPIOS. Methods: Participants were randomized to receive ofatumumab (20 mg subcutaneously every 4 weeks) or teriflunomide (14 mg orally once daily) for up to 30 months. Endpoints analysed post hoc in the protocol-defined RDTN population included annualized relapse rate (ARR), confirmed disability worsening (CDW), progression independent of relapse activity (PIRA) and adverse events. Results: Data were analysed from 615 RDTN participants (ofatumumab: n = 314; teriflunomide: n = 301). Compared with teriflunomide, ofatumumab reduced ARR by 50% (rate ratio (95% confidence interval (CI)): 0.50 (0.33, 0.74); p < 0.001), and delayed 6-month CDW by 46% (hazard ratio (HR; 95% CI): 0.54 (0.30, 0.98); p = 0.044) and 6-month PIRA by 56% (HR: 0.44 (0.20, 1.00); p = 0.049). Safety findings were manageable and consistent with those of the overall ASCLEPIOS population. Conclusion: The favourable benefit-risk profile of ofatumumab versus teriflunomide supports its consideration as a first-line therapy in RDTN patients. ASCLEPIOS I and II are registered at ClinicalTrials.gov (NCT02792218 and NCT02792231).

引用

页码：1562 / 1575

页数：14

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