Ofatumumab Increases NEDA Status, Apomorphine FDA Approved, Siponimod Reduces Risk of CDP


Neurology News Network for the week ending May 30, 2020.

This week Neurology News Network covered the results of the ASCLEPIOS I and II clinical trials of ofatumumab, the FDA approval of apomorphine in patients with Parkinson disease, and the phase 3 data of siponimod in patients with secondary progressive multiple sclerosis.

Marco Meglio: Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

Data from a pooled analysis of the phase 3 ASCLEPIOS I and II clinical trials suggest that patients with multiple sclerosis treated with ofatumumab have an increased likelihood of achieving no evidence of disease activity than those treated with teriflunomide. All told, the odds of achieving NEDA-3 status—defined as a composite of no 6-month confirmed disability worsening, no confirmed MS relapse, no new/enlarging T2 lesions, and no gadolinium-enhancing T1 lesions—were more than 3-fold higher for those administered ofatumumab from Months 0 to 12 compared to those taking teriflunomide. From Months 12 to 24, those odds increased to more than 8-fold higher for those on ofatumumab compared with teriflunomide. Additionally, treatment with Novartis’s fully human anti-CD20 monoclonal antibody was associated with a higher proportion of patients who were free from 6-month confirmed disability worsening, relapses, and lesion activity compared to those on over the 2-year period.

The FDA has approved Sunovion Pharmaceuticals’ apomorphine sublingual film for the treatment of motor fluctuations, or off episodes, in patients with Parkinson disease. The drug will be marketed under the name Kynmobi. Notably, it is the first therapy for OFF episodes associated with Parkinson disease that is administered sublingually. Stacy Wu, head of Global Clinical Research & Neurology at Sunovion, told NeurologyLive, ““Despite the significant prevalence—experienced by up to 60% of people with PD, within 4 to 6 years of diagnosis—and impact of off episodes, most treatments for off episodes have focused on keeping people on versus treating episodes when they occur.” She went on to say ““With apomorphine sublingual film, patients will have a new treatment option, with a novel route of administration, that can quickly improve mobility when disruptive off episodes occur. In a clinical trial, initial improvements in motor symptoms were observed in as little as 15 minutes post-dose.”

Data from the phase 3 EXPAND clinical trial of siponimod demonstrated the treatment’s ability to reduce the risk of confirmed disability progression in patients with secondary progressive multiple sclerosis with or without relapses. The risk reductions in non-relapsing patients in the 1 and 2 years before the study were 18% and 13 respectively. For 3-and 6-month CDP, the risk reductions were 25 and 18% respectively. Data presented at the 2020 Consortium of Multiple Sclerosis Centers (CMSC) Virtual Annual Meeting, revealed risk reductions of 33% and 33% for 3-month CDP in years 1 and 2, and 30% and 37% for 6-month CDP in years 1 and 2, in relapsing patients.

For more information on CMSC 2020, and for more direct access to expert insight, head to NeurologyLive.com. This has been Neurology News Network. Thanks for watching.

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