Ponesimod is an oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator taken once daily.
The U.S. Food and Drug Administration (FDA) approved ponesimod earlier this month for adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Results of the phase-3 OPTIMUM trial that led to approval are now published in JAMA Neurology.
"In the pivotal study, ponesimod demonstrated superior clinical efficacy in reducing annual relapses and MRI activity compared against teriflunomide, another oral MS therapy. Those results, combined with a favorable side effect profile, make ponesimod a useful treatment option for people with relapsing MS," Dr. Robert Fox, with the Mellen Center for MS Treatment and Research, Cleveland Clinic, in Ohio, said in a Janssen news release announcing approval (https://bit.ly/3w9voAt).
The trial enrolled 1,133 patients with relapsing-remitting MS, with half randomly allocated to ponesimod (20 mg) and half to teriflunomide (14 mg) once daily for 108 weeks. Ponesimod was gradually up-titrated over two weeks starting at 2 mg daily to mitigate potential first-dose cardiac effects associated with S1P1 modulators.
The annualized relapse rate (primary outcome) was significantly reduced by 30.5% with ponesimod versus teriflunomide. Over the study period, 71% of patients taking ponesimod had no confirmed relapses compared to 61% of patients taking teriflunomide.
Ponesimod was also superior to teriflunomide in two key secondary outcomes: reduction in combined unique active lesions per year (56% reduction) and MS-associated fatigue based on a validated questionnaire. The difference in rates of disability progression was not statistically significant.
Ponesimod was generally well tolerated, with no differences the incidence of treatment-emergent adverse events (88.8% vs. 88.2% with teriflunomide) or serious treatment-emergent adverse events (8.7% vs. 8.1%). However, treatment discontinuations due to adverse events were more common with ponesimod (8.7% vs. 6.0%).
The most common adverse events observed in the trial were upper respiratory infection, increased levels of hepatic transaminase, and hypertension.
"MS is a complex disease, and any individual's response to MS disease-modifying therapy can vary," Dr. Bruce Bebo, executive vice president of research at the National MS Society, said in the Janssen news release.
"It's so important that people living with MS have access to effective treatment options. We are pleased that there is a new therapy approved for relapsing MS," he added.
Funding for the study was provided by Janssen Research and Development LLC, with support from Actelion Pharmaceuticals, part of Janssen Pharmaceutical Companies. Several authors have disclosed financial relationships with the company.
SOURCE: https://bit.ly/3u5xCiA JAMA Neurology, online March 29, 2021.
By Reuters Staff
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