#ECTRIMS2018 – Better MS Monitoring and Disease Understanding Among Goals of FLOODLIGHT Open, Genentech Director Says
The ability to track multiple sclerosis (MS) at any time, gain a more complete picture of each patient’s disease course and a better understanding of MS are among the possible benefits of the FLOODLIGHT app, according to Laura Julian, PhD, principal medical science director at Genentech.
The company recently started a global study called FLOODLIGHT Open that uses the app to “assess the feasibility of monitoring disease activity and disability progression over the 365 days in a year that someone lives with MS, versus the two or three days they visit with their neurologist,” Julian said in an email interview with Multiple Sclerosis News Today.
FLOODLIGHT Open is an open-access study, which means anyone can join. Genentech expects this will give MS patients “the opportunity to participate in important research that may reveal new insights about how MS progresses,” Julian said.
“I am particularly excited about these ways that we can potentially advance the understanding of MS. We hope that this investigation will get the field closer to realizing this better understanding of MS for both patients and providers,” she added.
More than 400 patients — out of a planned total of 10,000 within five years — are now participating in the study, Julian said. Enrollment in the U.S. and in Canada is underway, with Europe expected to follow in the coming months and other countries joining later.
Anyone wanting to learn more or enroll should visit the study’s website or download the FLOODLIGHT app on iTunes (the app is free, but it requires users to have an iPhone with an iOS 11.0 or later system). Genentech and its owner, Roche, hope to have the app available in Google Play for Android by the end of the year.
Possible complement to clinic exams
FLOODLIGHT Open’s launch was based on the positive results of a pilot study (NCT02952911) presented at the recent 34th congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held in Berlin in October.
Data revealed a 76.5% adherence to active tests — questionnaires and simple tasks — and 83.2% to passive monitoring (like walking and mobility throughout a day) among the 61 MS patients who completed the study as of May 4. Patient satisfaction ratings were good to excellent (average score, 73.3 out of 100).
“We are pleased with the level of adherence and satisfaction seen in the proof of concept (PoC) study with the FLOODLIGHT technology,” Julian wrote. Unlike in FLOODLIGHT Open, study participants were not able to view their own progress and had to use an extra device — a preconfigured smartphone and smartwatch — which, she said, further underscore its positive results.
The pilot study also evaluated whether tests delivered through the app to track patients’ walking, hand function, and cognition — the Five-U-Turn Test of turning speed, a Pinching Test, and a smartphone-based Symbol Digit Modalities Test (SDMT), respectively — were in agreement with conventional in-clinic metrics for these same skills: the timed 25-Foot walk test, the 9-hole peg test, and the oral SDMT.
These three domains — walking, hand function, and cognition — are key for both MS patients and care providers, because they help clarify both disease status and response to treatment.
“Our results did suggest good agreement with these ‘in clinic’ metrics, further suggesting that the technology may be an important complement to regular in-clinic neurological exams,” Julian said, adding they might even “help provide a more complete and consistent picture of an individual’s functioning” than do the gold standard tests of neurological function. That’s yet to be determined, she added, because pilot study results are still being analyzed.
Anonymous data to aid science and doctors
Monitoring disease activity is valuable, and MS patients “work very hard to try to understand their own disease status and trajectory” using tools that run from activity trackers to calendars and notebooks. “Some even create their own spreadsheets!,” Julian said.
FLOODLIGHT allows people to track their disease’s impact at any time using their own dashboard, and Genentech believes its features of equal benefit to both progressive and relapsing MS patients.
But FLOODLIGHT also has a bigger goal: that of accumulating “meaningful data on large numbers of patients” — so-called big data — which has “the potential to advance our knowledge of the disease and how to best track progression over time.” All data collected is anonymous at the point of entry, so individuals cannot be identified, and participants can choose to share their data with family or doctors via a personal ID number, the program’s website states.
Continuously recording MS in all its aspects can be of help when visiting the neurologist, as trouble remembering details — particularly subtle symptoms that might reflect physical or mental functioning — is common, Julian said.
Because doctors can access data with patients’ permission, “[w]e hope to learn from providers as well, how they view these data,” Julian said. Overall, FLOODLIGHT may lead to developing “a tool that could be of value to both patients and providers.”
Advancing the science behind smartphone monitoring in MS is also among FLOODLIGHT Open’s goals. The anonymous data will be freely available to clinicians and scientists to quicken their own research and foster collaboration.
Roche and Genentech have also incorporated the FLOODLIGHT app into clinical trials as a novel endpoint, or goal. Using the app in collaborations with “leading medical institutions and health systems” may also help “understand how mobile technology integrates with clinical workflows and how it may potentially augment clinical care,” Julian said.