Experts not satisfied with Results of Roche’s New Treatment for Multiple Sclerosis
A Swiss drug maker Roche revealed that its new treatment for multiple sclerosis has shown positive results. But positive results from the ORATORIO study have left experts in question about the magnitude of benefits in the primary progressive multiple sclerosis (PPMS).
According to Xavier Montalban from Vall d'Hebron University Hospital in Barcelona, and colleagues , the anti-CD20+ therapy significantly reduced the proportion of patients who had 12-week confirmed disability progression by 24% compared with placebo.
It also significantly reduced 24-week confirmed disability progression, T2 lesion volume, and whole brain volume loss. During a meeting at the European Committee for Treatment and Research in Multiple Sclerosis, Montalban reported that the new treatment also preserved scores on the 'Timed 25-Foot Walk' test compared with placebo.
Several experts who were not part of the study said the primary progressive data were less impressive than those seen for relapsing-remitting disease in the OPERA studies presented at the meeting.
David Hafler, MD, of Yale University in New Haven, said, "While anti-CD20+ treatment for relapsing-remitting disease looked like a home run, these data in primary progressive disease are not nearly as impressive".
The trial included a younger group with shorter duration than in previous trials in PPMS. Therefore it is not representative of most PPMS patients that neurologists are seeing today.
Most experts said they want to wait and see planned subgroup analyses before coming to any further conclusions about the data.
Ocrelizumab is not the first anti-CD20+ monoclonal antibody tested in progressive as well as relapsing-remitting MS. The pioneering drug in this class, rituximab, has also been tested in both progressive and relapsing-remitting MS.
"This is a younger group with shorter duration than in previous trials in PPMS," Bourdette told MedPage Today. "It is also not representative of most PPMS patients that neurologists are seeing today. It should encourage us to identify PPMS earlier in their course."
