ORATORIO trial results positive, but not impressive enough
BARCELONA — Enthusiasm for ocrelizumab was tempered after positive results from the ORATORIO study, presented during a late-breaking presentation here, left researchers with questions about the magnitude of benefit in primary progressive multiple sclerosis (PPMS
The anti-CD20+ therapy did indeed significantly reduce the proportion of patients (mean age of 44.6 at baseline) who had 12-week confirmed disability progression by 24% compared with placebo (P=0.0321), according to Xavier Montalban, MD, PhD, of Vall d’Hebron University Hospital in Barcelona, and colleagues.
It also significantly reduced 24-week confirmed disability progression, T2 lesion volume, and whole brain volume loss, and preserved scores on the Timed 25-Foot Walk test compared with placebo, Montalban reported at the European Committee for Treatment and Research in Multiple Sclerosis meeting.
But several experts who were not involved in the study and were contacted by MedPage Today said the primary progressive data were less impressive than those seen for relapsing-remitting disease in the OPERA studies that were also presented at the meeting.
“While anti-CD20+ treatment for relapsing-remitting disease looked like a home run, these data in primary progressive disease are not nearly as impressive,” David Hafler, MD, of Yale University in New Haven, Conn., who was not involved in the study, told MedPage Today.