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- Title
Ofatumumab Versus Teriflunomide in Relapsing Multiple Sclerosis: Analysis of No Evidence of Disease Activity (NEDA-3) from the ASCLEPIOS I and II Trials.
- Authors
Hauser, Stephen L.; Bar-Or, Amit; Cohen, Jeffrey A.; Comi, Giancarlo; Correale, Jorge; Coyle, Patricia K.; Cross, Anne H.; de Seze, Jérôme; Montalban, Xavier; Selmaj, Krzysztof; Wiendl, Heinz; Willi, Roman; Bingbing Li; Häring, Dieter A.; Ramanathan, Krishnan; Merschhemke, Martin; Kappos, Ludwig
- Abstract
Background: Ofatumumab, the first fully human anti-CD20 monoclonal antibody, demonstrated superior efficacy vs teriflunomide in the phase 3 ASCLEPIOS I/II relapsing multiple sclerosis (RMS) trials. No evidence of disease activity (NEDA-3), a comprehensive composite measure, is commonly used to determine the treatment outcome in RMS. Objectives: To investigate the effect of subcutaneous ofatumumab 20 mg (monthly) vs oral teriflunomide 14 mg (once daily) in achieving NEDA-3, and to separately assess the annualized relapse rate (ARR) and gadolinium-enhancing (Gd+) T1 lesion activity in the pooled ASCLEPIOS I/II trials. Methods: We pooled data from the ASCLEPIOS I (n = 927) and II (n = 955) trials. Outcomes included NEDA-3 (defined as a composite of no 6-month confirmed disability worsening [6mCDW], no confirmed multiple sclerosis relapse, no new/enlarging T2 lesions, and no Gd+ T1 lesions) and its individual components in a modified full analysis set (modified FAS; logistic regression model). ARR by time intervals and Gd+ T1 lesions in the FAS (negative binomial model for both) were also analyzed. Results: The odds of achieving NEDA-3 with ofatumumab vs teriflunomide were >3-fold higher at month (M) 0-12 (47.0% vs 24.5% of patients; odds ratio [95% CI]: 3.36 [2.67; 4.21], P < .001) and >8-fold higher at M12-24 (87.8% vs 48.2% of patients; 8.09 [6.26; 10.45], P < .001). Over 2 years, a higher proportion of ofatumumab-treated patients were free from 6mCDW (91.9% vs 88.9%), relapses (82.3% vs 69.2%), and lesion activity (54.1% vs 27.5%) compared with teriflunomide. Ofatumumab significantly reduced ARR compared with teriflunomide at all cumulative time intervals: M0-3 (P = .011), and all subsequent time intervals from M0-27 (P < .001). Ofatumumab significantly reduced the mean number of Gd+ T1 lesions per scan by 95.9% compared with teriflunomide (mean [95% CI]: 0.02 [0.01; 0.03] vs 0.50 [0.42; 0.59]; P < .001). Conclusions: Ofatumumab increased the probability of achieving NEDA-3 and demonstrated superior efficacy vs teriflunomide in patients with RMS.
- Subjects
THERAPEUTIC use of monoclonal antibodies; CONFERENCES &; conventions; IMMUNOSUPPRESSIVE agents; MULTIPLE sclerosis
- Publication
International Journal of MS Care, 2020, Vol 22, Issue S2, p85
- ISSN
1537-2073
- Publication type
Article