MS PATHS, a way of capturing data on disease progression and treatment response in thousands of multiple sclerosis (MS) patients being treated at any of 10 participating clinics, has among its goals that of making clinical remission — a prolonged absence of any disease activity — possible, said an executive at Biogen, which developed the program.
“We have the idea that what patients want, and what doctors ought to strive for, is disease remission, kind of like cancer, where there’s no sign of active or progressive disease,” Rick Rudick, MD, vice president for development sciences at Biogen, said in an interview with Multiple Sclerosis News Today at the 34th congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) that concluded in Berlin last week.
“That’s what the cancer patient wants; we think that’s what MS patients would want,” Rudick added.
How remission might be defined, or in how many different ways, is still being determined, Rudick said. But “if we could use tests and monitoring properly, we could get a lot patients into remission.”
A total of 14,000 people with all MS subtypes are now taking part in MS PATHS, up from 5,000 in 2017, at 10 centers: seven in the U.S. — including the Cleveland Clinic, Johns Hopkins, NYU Langone and Ohio Health — two in Germany, and one in Spain.
Patients begin clinic visits about a half-hour earlier, going through a series of tests to capture changes in parameters like cognition, mobility, vision, and dexterity. Data are electronically recorded and viewed by the physician before an exam begins.
Privacy is assured, Rudick said, with all data stripped of identifying information, coded and aggregated, before it leaves the care center — a major concern for patients, and one expressed in some columns published in MS News Today. “We can’t identify who the patient is,” Rudick said. “Otherwise, we would be violating all the privacy rules.”
Rather, data is meant to allow for “large-scale learning” at the point of patient care, and more time for a doctor to spend listening to and observing patients — their response to treatment, their perceptions of changes in their health — rather than time spent in taking tests.
All health professionals working with patients in the 10-center network have access to the data — but not others — and can use information collected for their own research, Rudick said.
Because patients in MS PATHS are part of a clinical care setting, rather than those meeting the precise requirements of a formal clinical trial, they’re more representative of the entire MS population. This arrangement also might help to lower healthcare costs by lessening the need for formal studies.
Formal research is very valuable, said Rudick — who first came up with the idea of an MS PATHS program while practicing neurology at the Cleveland Clinic, where he was director of the Mellen Center for Multiple Sclerosis — and it’s expensive, with about $100 billion in the U.S. alone each year. But healthcare — that given patients at medical offices nationwide — costs $4 trillion annually.
“So, we’ve been learning from 3 percent of the investment,” rather than trying to collect “research-quality data” from its other 97 percent. “I think it has real implications for learning in healthcare,” he said, “and that’s really where we want to go.”
Key information that might inform patient care is probably a few years away — the program largely got underway last year — with Rudick estimating that five years of consecutive patient data will be crucial. But some new insights are becoming evident, especially in terms of cognition and how thinking speeds are affected by the disease.
One of the self-assessment exams given on an iPad, called the Processing Speed Test developed at the Cleveland Clinic and licensed by Biogen for MS PATHS, revealed “a higher occurrence of cognitive impairment than we would have predicted,” or published studies into MS would have led us to believe, Rudick said.
Specifically, results in about 2,000 patients followed for at least one full year showed that 15 percent had “what we think are cognitive relapses,” he said, cases in which cognitive test scores declined even as physical scores held steady. “We’re coming to believe there are cognitive relapses, which we have not recognized” before, Rudick noted.
Cognition, or clarity and speed in higher-level thinking processes, underlies all aspects of life, but perhaps especially the independence that MS patients, as those with other chronic ills, most want to maintain.
Another PATHS goal
A secondary MS PATHS goal is looking at the disease’s socioeconomic toll, which includes the ability to support oneself and live independently.
“We’re … beginning to learn the importance of some of the measures that we’re making,” Rudick said. “I think that’s going to be increasingly important.”
Recognizing this finding, Biogen also licensed an iPad app with that processing speed test called CogEval, for use by MS specialists anywhere at any time — the only requirement being that they register before using it, essential under the terms of the app’s license, and have their own iPad, Rudick said.
And MS PATHS is feeding into more traditional research, both that of rigorous trials and “pragmatic trials” that might test different diets, or exercise programs, and randomize one group of patients to do one thing and another to do something else.
The program is producing “quality data,” Rudick said, that scientists at a network site can use to support “their research grants” or as part of collaborative work among network researchers.
Scientists across the field are “struggling with need to learn from patients and deploy technology,” Rudick said, “a lot … are trying to do what we’re doing at MS PATHS.”