| Autor: |
Havrdová, Eva, Arnold, Douglas L., Bar-Or, Amit, Comi, Giancarlo, Hartung, Hans-Peter, Kappos, Ludwig, Lublin, Fred, Selmaj, Krzysztof, Traboulsee, Anthony, Belachew, Shibeshih, Bennett, Iain, Buffels, Regine, Garren, Hideki, Han, Jian, Julian, Laura, Napieralski, Julie, Hauser, Stephen L., Giovannoni, Gavin |
| Předmět: |
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| Zdroj: |
Multiple Sclerosis Journal - Experimental, Translational & Clinical; Jan-Mar2018, Vol. 4 Issue 1, p1-1, 1p |
| Abstrakt: |
Background No evidence of disease activity (NEDA; defined as no 12-week confirmed disability progression, no protocol-defined relapses, no new/enlarging T2 lesions and no T1 gadolinium-enhancing lesions) using a fixed-study entry baseline is commonly used as a treatment outcome in multiple sclerosis (MS). Objective The objective of this paper is to assess the effect of ocrelizumab on NEDA using re-baselining analysis, and the predictive value of NEDA status. Methods NEDA was assessed in a modified intent-to-treat population (n = 1520) from the pooled OPERA I and OPERA II studies over various epochs in patients with relapsing MS receiving ocrelizumab (600 mg) or interferon beta-1a (IFN β‐1a; 44 μg). Results NEDA was increased with ocrelizumab vs IFN β-1a over 96 weeks by 75% (p < 0.001), from Week 0‒24 by 33% (p < 0.001) and from Week 24‒96 by 72% (p < 0.001). Among patients with disease activity during Weeks 0‒24, 66.4% vs 24.3% achieved NEDA during Weeks 24‒96 in the ocrelizumab and IFN β-1a groups (relative increase: 177%; p < 0.001). Conclusion Superior efficacy with ocrelizumab compared with IFN β-1a was consistently seen in maintaining NEDA status in all epochs evaluated. By contrast with IFN β-1a, the majority of patients with disease activity early in the study subsequently attained NEDA status with ocrelizumab. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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