Almost two-thirds of people newly diagnosed with multiple sclerosis (MS) in the United States, identified through a national database, were not prescribed disease-modifying therapies (DMTs) over an average of more than two years of follow-up, a real-world study of nearly 5,700 patients found.
Current guidelines “recommend early treatment with DMTs,” its researchers wrote, pointing to a possibly troubling “gap” between those guidelines and real-world use.
They also noted that the data used, while selective to ensure accuracy, did not address disease severity, and that treatment might have begun outside this follow-up period.
The study, “Treatment patterns and comorbid burden of patients newly diagnosed with multiple sclerosis in the United States,” was published in BMC Neurology.
Most MS patients, around 85%, are diagnosed initially with relapsing-remitting MS (RRMS), and a number over time will transition to secondary progressive MS (SPMS). Prior to the availability of disease-modifying therapies, studies estimated that 50% of all RRMS patients would make this shift within 10 years, and 90% within 25 years, the National MS Society reports.
DMTs — treatments that address a disorder’s underlying causes — tend to work better in the RRMS phase, becoming less effective with the move to SPMS because of fewer relapses and lesser disease activity.
In fact, the American Academy of Neurology includes guidelines on starting newly diagnosed patients on DMTs, and both the European Committee of Treatment and Research in Multiple Sclerosis and the European Academy of Neurology recommend early treatment with DMTs for patients with active RRMS.
Although more than a dozen DMTs have been approved to treat RRMS, detailed knowledge of treatment patterns and research that looks beyond treatment switching, adherence, and preference in type (injection or oral therapy) is lacking.
Researchers with Janssen, a pharmaceutical company owned by Johnson & Johnson, in its New Jersey Research and Development office, examined five years worth of follow-up data from newly diagnosed MS patients, covering the first four lines of therapy these patients received.
They identified 5,691 people diagnosed with MS over the five years spanning January 2014 and June 2019 from a national insurance claims database. These patients average age was 52.8, and 73% of them were female. They were followed for a median of 2.4 years, and all had either public or private insurance coverage.
This patient group was slightly older at age of onset, on average, than most MS patients, who are typically between 20 to 40 at diagnosis, the researchers stated. As such, this group may include a higher proportion of people with progressive forms of MS. Hospital admission codes do not specify MS subtypes.
The most common comorbidities — or coexisting conditions — reported in this study were hypertension (41% of patients), high cholesterol (29%), and vitamin D deficiency (28%), the latter known to be associated with both MS risk and disease activity.
The researchers found that 35% of these patients, or 1,994 people, received a DMT at some point during follow-up. From the time of their diagnosis, they waited an average of 169 days (about 5.6 months) for a first treatment. This means the rest, accounting potentially for almost two-thirds (65%) of these patients, were not prescribed a DMT throughout follow-up.
About 28% of those given a first DMT later switched to a second line of therapy, 5.8% received a third, and 0.9% were prescribed a fourth DMT over the follow-up period. Only 1.8% of all treated patients were on more than one DMT simultaneously.
Glatiramer acetate (sold as Copaxone, by Teva Pharmaceuticals, and Glatopa by Sandoz, among other generics) and Tecfidera (dimethyl fumarate, by Biogen) accounted for nearly 62% of first-line treatments.
Second-line treatment choices were more diverse, with more than 10% of patients given Tecfidera, Aubagio (teriflunomide, by Sanofi), Ocrevus (ocrelizumab, by Genentech), Gilenya (fingolimod, by Novartis), and Tysabri (natalizumab, by Biogen) as a second DMT. Ocrevus was as the most common third DMT choice.
Among patients needing to change medications, those beginning with glatiramer acetate were more likely to move to Tecfidera, while those who began with Tecfidera were most likely to switch to Aubagio. Gilenya, glatiramer acetate, and Ocrevus shared similar rates of second-line treatment choices.
First-line treatments fell into two groups: Group A consisted of the interferons Tecfidera, Aubagio, and glatiramer, while Group B consisted of all others.
Slightly more than half (53%) of patients given a second-line therapy switched among Group A options. Another 35% moved from Group A to Group B treatments. The rest either switched between Group B (8%) or went from a Group B therapy to one in Group A (4%).
Overall, the study found that roughly one-third of newly diagnosed MS patients received DMTs and that the most frequently prescribed options were glatiramer and Tecfidera. Approximately a quarter of treated patients later switched to other DMTs.
“Even when considering that a small portion of the population may not have been RRMS patients, either because they have another form of MS or they were incorrectly classified in the claims data, there still appears to be a gap between what the recommended treatment course is and what is happening in the real world,” the researchers wrote.
The high prevalence and wide spectrum of comorbidities among these patients also “illustrates how MS can have a large effect on a patient’s overall health,” they wrote.
“The comorbid burden of MS patients is significant and diverse, effecting the physical and mental well-being of individuals,” they added.
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