دورية أكاديمية
Ofatumumab versus Teriflunomide in Multiple Sclerosis.
| العنوان: | Ofatumumab versus Teriflunomide in Multiple Sclerosis. |
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| المؤلفون: | Hauser, Stephen L, Bar-Or, Amit, Cohen, Jeffrey A, Comi, Giancarlo, Correale, Jorge, Coyle, Patricia K, Cross, Anne H, de Seze, Jerome, Leppert, David, Montalban, Xavier, Selmaj, Krzysztof, Wiendl, Heinz, Kerloeguen, Cecile, Willi, Roman, Li, Bingbing, Kakarieka, Algirdas, Tomic, Davorka, Goodyear, Alexandra, Pingili, Ratnakar, Häring, Dieter A, Ramanathan, Krishnan, Merschhemke, Martin, Kappos, Ludwig, ASCLEPIOS I and ASCLEPIOS II Trial Groups, Van Pesch, Vincent |
| المساهمون: | UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire |
| المصدر: | The New England journal of medicine, Vol. 383, no. 6, p. 546-557 (2020) |
| بيانات النشر: | Massachusetts Medical Society |
| سنة النشر: | 2020 |
| المجموعة: | DIAL@UCL (Université catholique de Louvain) |
| مصطلحات موضوعية: | Adult, Antibodies, Monoclonal, Humanized, B-Lymphocytes, Brain, Crotonates, Disease Progression, Double-Blind Method, Female, Humans, Injections, Subcutaneous, Kaplan-Meier Estimate, Magnetic Resonance Imaging, Male, Multiple Sclerosis, Relapsing-Remitting, T-Lymphocytes, Toluidines |
| الوصف: | Ofatumumab, a subcutaneous anti-CD20 monoclonal antibody, selectively depletes B cells. Teriflunomide, an oral inhibitor of pyrimidine synthesis, reduces T-cell and B-cell activation. The relative effects of these two drugs in patients with multiple sclerosis are not known. In two double-blind, double-dummy, phase 3 trials, we randomly assigned patients with relapsing multiple sclerosis to receive subcutaneous ofatumumab (20 mg every 4 weeks after 20-mg loading doses at days 1, 7, and 14) or oral teriflunomide (14 mg daily) for up to 30 months. The primary end point was the annualized relapse rate. Secondary end points included disability worsening confirmed at 3 months or 6 months, disability improvement confirmed at 6 months, the number of gadolinium-enhancing lesions per T1-weighted magnetic resonance imaging (MRI) scan, the annualized rate of new or enlarging lesions on T2-weighted MRI, serum neurofilament light chain levels at month 3, and change in brain volume. Overall, 946 patients were assigned to receive ofatumumab and 936 to receive teriflunomide; the median follow-up was 1.6 years. The annualized relapse rates in the ofatumumab and teriflunomide groups were 0.11 and 0.22, respectively, in trial 1 (difference, -0.11; 95% confidence interval [CI], -0.16 to -0.06; P<0.001) and 0.10 and 0.25 in trial 2 (difference, -0.15; 95% CI, -0.20 to -0.09; P<0.001). In the pooled trials, the percentage of patients with disability worsening confirmed at 3 months was 10.9% with ofatumumab and 15.0% with teriflunomide (hazard ratio, 0.66; P = 0.002); the percentage with disability worsening confirmed at 6 months was 8.1% and 12.0%, respectively (hazard ratio, 0.68; P = 0.01); and the percentage with disability improvement confirmed at 6 months was 11.0% and 8.1% (hazard ratio, 1.35; P = 0.09). The number of gadolinium-enhancing lesions per T1-weighted MRI scan, the annualized rate of lesions on T2-weighted MRI, and serum neurofilament light chain levels, but not the change in brain volume, were in ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0028-4793 1533-4406 |
| العلاقة: | boreal:239829; http://hdl.handle.net/2078.1/239829Test; info:pmid/32757523; urn:ISSN:0028-4793; urn:EISSN:1533-4406 |
| DOI: | 10.1056/NEJMoa1917246 |
| الإتاحة: | https://doi.org/10.1056/NEJMoa1917246Test http://hdl.handle.net/2078.1/239829Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.B4215AC7 |
| قاعدة البيانات: | BASE |
| تدمد: | 00284793 15334406 |
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| DOI: | 10.1056/NEJMoa1917246 |