New data show ocrelizumab reduces disease progression in multiple sclerosis

Genentech, has announced that new Ocrevus (ocrelizumab) data are presented at the 7th Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) – Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Meeting in Paris, France. The data presented showcase clinical advances around underlying disease activity and disability progression in relapsing and progressive forms of multiple sclerosis (MS), through the exploration of newly emerging endpoints and precision monitoring.

Ocrevus significantly reduced the proportion of people with relapsing multiple sclerosis (RMS) who experienced Progression Independent of Relapse Activity (PIRA) in a post-hoc analysis compared to Rebif (interferon-beta 1a). This effect was particularly seen in those who were potentially at higher risk of progressive disease course based on their baseline Expanded Disability Status Scale (EDSS). Specifically, in this analysis, Ocrevus treatment reduced the risk of PIRA by 25 percent and 23 percent confirmed at 12 and 24 weeks, respectively (p=0.008 and p=0.039, respectively). PIRA is a newly emerging MS endpoint intended to measure an increase in disability, which is related to underlying disease activity in RMS. These data were generated through a post-hoc analysis of more than 1,600 people randomly assigned to treatment in OPERA I and OPERA II, and assessed for PIRA, as measured by cCDP. cCDP is a measure of the risk of a person’s physical disability getting worse and is based on three measures of physical disability – confirmed disability progression, walking speed and upper extremity function.

A platform presentation, also highlighting underlying disease activity, showed that a new algorithm using conventional MRI can be used as a possible biomarker to automatically detect Slowly Evolving Lesions (SELs), as a potential measure of chronic disease activity outside of acute lesions in the brain. SELs were shown to evolve independently of acute lesions leading to enhanced focal brain tissue loss, as measured by T1 black hole evolution. Further research is needed, but this algorithm for automatic detection of SELs using conventional brain MRI may provide a marker of chronic disease activity in MS lesions.

New data from the FLOODLIGHT clinical trial program, which is designed to assess sensor-based outcomes from a series of active neurological tests and passive monitoring through the use of a smartphone is also being presented. The tool enables a continuous stream of precise, real-world MS disease progression data to be collected and analyzed using dedicated algorithms and machine learning. Data at ECTRIMS – ACTRIMS demonstrate strong patient adherence to the FLOODLIGHT technology. Hand/arm function measured with a smartphone-based pinching test may detect subclinical impairment in those who have normal Nine-Hole Peg Test (9-HPT) performances. Turning speed measured with a smartphone-based U-Turn Test was shown to correlate with the Timed 25-Foot Walk (T25-FW) (p<0.001), and may detect subclinical activity compared to normal in-clinic performances. The data support FLOODLIGHT as a potential complement to in-clinic testing to provide a more complete and consistent picture of a patient’s disease progression.Additionally, OPERA I, OPERA II and ORATORIO Phase III open-label extension data presented at ECTRIMS – ACTRIMS continue to show a favorable benefit-risk profile for Ocrevus.