ECTRIMS: Genentech Data Signals Emphasis on Multiple Sclerosis Disease Progression, Disability
Data presented by Genentech 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 highlight clinical advances around underlying disease activity and disability progression in relapsing and progressive forms of multiple sclerosis (MS). In a post-hoc analysis of more than 1,600 patients from the OPERA I and OPERA II trials comparing ocrelizumab (Ocrevus) to interferon-beta 1a (Rebif, EMD Serono), investigators noted that ocrelizumab significantly reduced the proportion of people with relapsing MS who experienced Progression Independent of Relapse Activity (PIRA), a new endpoint that is intended to separate relapse activity from underlying activity and measure disability.
“Patients who have disease progression have disability that’s irreversible, and PIRA is a way to measure that.” said Hideki Garren, MD, Group Medical Director for ocrelizumab, in an interview with Practical Neurology® magazine. Specifically, ocrelizumab reduced the risk of PIRA by 25 percent and 23 percent confirmed at 12 and 24 weeks, respectively. The reduction of PIRA in patients treated with ocrelizumab was particularly evident in those who were potentially at higher risk of progressive disease course. Dr. Garren further noted that PIRA represents an effective way to understand the impact of disease progression and disability on quality of life.
Another presentation highlighting underlying disease activity showed that a new MRI-based algorithm using MRI may be a possible biomarker to detect Slowly Evolving Lesions (SELs). “What we see particularly in patients with progressive disease is that lesions continue to expand, and this data shows how this algorithm using traditional MRI can detect these SELs and also gain a better look and understanding of the underlying progression of disease,” Dr. Garren explained.
Genentech also presented from its ongoing FLOODLIGHT clinical trial program, which assesses sensor-based outcomes through the use of a smartphone from a series of active neurological tests and passive monitoring. “Using an advanced algorithm to mine data, the passive testing of hand/arm function allows us to potentially measure underlying disease progressions without the patient event knowing,” Dr. Garren observed. The FLOODLIGHT program also includes an active testing element, which consists of specifically designed smartphone tests that patients take once daily that provides real-world feedback and increase understanding of underlying disease progression. According to Dr. Garren, Genentech is showcasing the technology for the first time at ECTRIMS-ACTRIMS and is will continue data collection with the goal to validate in the near future.