Janssen announced results from the phase 3 OPTIMUM study comparing treatment with ponesimod vs teriflunomide in patients with relapsing multiple sclerosis. The findings were recently presented at the 35th Congress of The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm, Sweden.
Ponesimod is a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that reduces the number of circulating lymphocytes by inhibiting S1P activity. The investigational drug is believed to prevent immune cells from crossing the blood-brain barrier which leads to demyelination typically seen in patients with multiple sclerosis.
OPTIMUM was a multicenter, randomized, double-blind, active-controlled, parallel-group, phase 3 superiority study that compared the efficacy and safety of oral ponesimod 20mg to teriflunomide 14mg (Aubagio; Sanofi Genzyme) in adult patients (N=1133) with relapsing multiple sclerosis for a duration of 108 weeks. The primary end point was the annualized relapse rate (ARR) up to the end of the study; key secondary end points included the change from baseline to week 108 in fatigue-related symptoms and in cumulative number of combined unique active lesions (CUAL).
Results showed ponesimod significantly reduced ARR by 30.5% when compared with teriflunomide (ARR=0.202 for ponesimod 20mg vs 0.290 for teriflunomide 14mg, P =.0003). Additionally, ponesimod demonstrated statistically significant effects on fatigue symptoms, as measured by the Fatigue Symptoms and Impacts Questionnaire – Relapsing Multiple Sclerosis (FSIQ-RMS), compared with teriflunomide (mean difference: -3.57, P =.0019); a 56% reduction in the number of CUALs was observed with ponesimod vs teriflunomide (P <.0001).
Regarding safety, the most common treatment-emergent adverse events were nasopharyngitis, headache, upper respiratory tract infections and an increase in alanine aminotransferase.
“This is the first large controlled head-to-head study comparing two oral compounds for the treatment of relapsing MS. 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,” said Professor Ludwig Kappos, Chair of the Department of Neurology at University Hospital of Basel, Switzerland.
Data from the OPTIMUM study will be included in the regulatory submission to the FDA.
For more information visit janssen.com.