Men who started on high-efficacy DMTs had fewer relapses: Analysis
However, initial DMT did not affect relapse rate for women in US study
Men with multiple sclerosis (MS) who started on high-efficacy disease-modifying therapies (DMTs) experienced significantly fewer relapses than those who started with moderate-efficacy DMTs, according to real-world claims analysis involving more than 10,000 U.S. patients.
“No significant difference in relapse was found among females,” researchers wrote. “This observation highlights the importance of recognizing sex as a potential factor in differentiating the treatment response.”
The study, “Comparative effectiveness of high-efficacy and moderate efficacy disease-modifying agents in reducing the annualized relapse rates among multiple sclerosis patients in the United States,” was published in Preventive Medicine.
MS is an inflammatory disease marked by damage to the myelin sheath, or the insulating cover on nerve fibers in the brain and spinal cord. More than 20 DMTs are now approved to prevent that damage and slow disease progression, each with its own safety and efficacy profile.
High-efficacy DMTs are newer, more potent, costlier, carry greater safety risks
Current DMTs can be broadly grouped into high-efficacy and moderate-efficacy. High-efficacy therapies, or heDMTs, are newer therapies that potently reduce MS activity and slow disease progression but carry greater safety risks and are also more costly. Moderate-efficacy therapies, or meDMTs, are generally safer but are less effective at slowing disease.
In the past, doctors would often employ an escalation approach, whereby patients are first given an meDMT and then, if they showed signs of disease activity, are switched to an heDMT. Emerging evidence, however, suggests that starting on an heDMT soon after diagnosis is better at improving the long-term outlook of patients.
Because these studies were conducted in European countries, “limited real-world evidence exists regarding the comparative effectiveness of heDMTs and meDMTs in the United States,” the researchers wrote.
To address this, a research team based at the University of Houston, in Texas, compared the effectiveness of the two classes of DMTs among adult MS patients in the U.S. They also sought to determine if there were differences in treatment responses between men and women.
The researchers gathered data from the U.S. Merative MarketScan Commercial Claims and Encounters dataset, which contains deidentified insurance claims collected from inpatient, outpatient, and community pharmacy settings. Most patients in the database are insured through large companies, governments, or nonprofit organizations.
“Given that most multiple sclerosis patients are working-aged adults, the MarketScan data is one of the optimal options for evaluating this study objective,” the team noted.
The study looked at 10,003 adults who had been diagnosed with MS from 2015-2019 and prescribed at least one DMT after their diagnosis. They were followed until they switched to another DMT, left the database, or the study ended.
77% started on moderate-efficacy DMTs
Among the participants, about three-quarters (77.1%) started treatment with an meDMT, which included glatiramer acetate (sold as Copaxone and others) and dimethyl fumarate (available as Tecfidera and generics). The remaining 22.9% began with an heDMT, including Ocrevus (ocrelizumab), Lemtrada (alemtuzumab), and Tysabri (natalizumab).
Patients who started on an heDMT were significantly older and had more severe MS than meDMT users. Notably, more men started on heDMTs than women (28.0% vs. 21.2%).
DMT effectiveness was measured by the annualized relapse rate (ARR), or the average number of relapses per year in each patient group, during follow-up.
Results showed the average ARR was significantly lower for heDMT users than meDMT users (0.25 vs. 0.28 relapses per year). However, only men had a significantly lower risk of relapse — by 26% — when they began with heDMTs. For women, the ARR during follow-up was the same regardless of whether they started with heDMTs or meDMTs.
“The study found the effect of [heDMT] on ARR was moderated by sex,” the scientists concluded. “Among male patients, heDMTs demonstrated a significant decrease in ARR compared to meDMT users; however, no difference in ARR was observed among female patients. … Future studies are warranted to explore and investigate the sex-specific variation in treatment effectiveness to improve patient outcomes in multiple sclerosis.”
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