Ponesimod Superior to Teriflunomide for Relapsing Multiple Sclerosis in Phase 3 Trial

In the phase 3 OPTIMUM study (NCT02425644), adults with relapsing multiple sclerosis (MS) treated with ponesimod (Janssen Pharmaceuticals, Titusville, NJ) had a 30.5% reduction in annualized relapse rate (ARR) compared with those treated with teriflunomide (Aubagio; Genzyme, Cambridge, MA). The ARR for those treated with 20 mg of ponesimod was 0.202 vs 0.290 for 14 mg of teriflunomide (P = .0003). 

Treatment with ponesimod also reduced the cumulative number of combined unique active lesions (CUAL) by 56% (P < .0001) compared with treatment with teriflunomide and statistically significant improvement in fatigue (mean difference -3.57 points on the Fatigue Symptoms and Impacts Questionnaire—Relapsing Multiple Sclerosis [RMS]; P = .0019). 

"This is the first large, controlled, head-to-head study comparing two oral compounds for the treatment of relapsing MS,” said Ludwig Kappos, chair, Department of Neurology at University Hospital of Basel, Switzerland. “Notably, we saw superiority of the investigational agent ponesimod when compared to teriflunomide across the primary and most secondary endpoints. These data, in conjunction with the observed safety profile, underline the potential of ponesimod as a new treatment option for MS." 

In this head-to-head comparative trial, participants (n = 1,333) were randomly assigned to receive treatment with ponesimod or teriflunomide for 108 weeks. Ponesimod is an investigational selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that inhibits S1P activity and reduces the number of circulating lymphocytes.