October 11, 2018—Results from new analysis of the phase 3 ORATORIO study (NCT01194570) were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Berlin, Germany October 10-12.
In this study, 732 adult patients with primary progressive multiple sclerosis (PPMS) who had expanded disability status scale (EDSS) scores ranging from 3.0 to 6.5, were randomly assigned (2:1) to receive ocrelizumab or placebo for 120 weeks or more. The primary endpoint was a prespecified number of progression events on the EDSS occurred.
At the end of ORATORIO double-blind period, patients remained on the treatment they had been randomized to in an extended controlled period while the trial outcome was determined. After this time, patients switched from placebo to or continued treatment with ocrelizumab.
During the double-blind and extended control periods, treatment with ocrelizumab reduced the risk of 24-week confirmed disability progression by 25% (P = .037) and 24-week CDP-9HPT by 45% (P < .001). Patients treated with placebo then ocrelizumab had increasing percentages without disability progression as the length of time they were treated with ocrelizumab increased, but these were not as high as the percentage of patients without disability for the group treated with ocrelizumab the entire time (Table).
In addition, subgroup analyses of ORATORIO results showed that treatment with ocrelizumab reduced progression of upper limb disability in more disabled/older PPMS patients, and that the relative risk reduction was similar between patients with scores above or below 6 on the EDSS (40% vs 38%, interaction P = .9187) and between patients whose time on the 9HPT was over or under 25 seconds (49% vs 44%, interaction P = .8221).
These findings suggested that treatment with ocrelizumab may meet an unmet need for patients with PPMS, potentially promoting their ability to live independently given that upper limb function is necessary for activities of daily living, especially when lower limb function is compromised.
Based in part on this observation, the ORATORIO-HAND study has been designed to further investigate the efficacy of OCR on upper limb function in a rigorous, controlled manner. Eligible patients will be randomly assigned (1:1) to OCR or PBO for ≥120 weeks and until a pre-specified number of confirmed 9HPT progression events (primary endpoint) occur. To enroll, patients must be adults with EDSS scores from 3.0 to 8.0 for whom the 9HPT > 25s.Next Story