Ofatumumab versus Teriflunomide in Multiple Sclerosis.

SL Hauser, A Bar-Or, JA Cohen, G Comi, J Correale, PK Coyle, AH Cross, Seze J de, D Leppert, X Montalban, K Selmaj, H Wiendl, C Kerloeguen, R Willi, ASCLEPIOS I and ASCLEPIOS II Trial Groups

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229 Citations (Scopus)


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
Among patients with multiple sclerosis, ofatumumab was associated with lower annualized relapse rates than teriflunomide.
Original languageEnglish
Pages (from-to)546-557
Number of pages12
JournalThe New England Journal of Medicine
Issue number6
Publication statusPublished - 6 Aug 2020


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