Real-world study finds fewer MS relapses with Vumerity vs. Tecfidera
Researchers say fewer gastro side effects may make newer therapy better
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A patient choosing between two similar medications can turn to healthcare professionals, including pharmacists, for help.
- Vumerity significantly cuts multiple sclerosis relapse rates compared with Tecfidera, a real-world study found.
- The better results with Vumerity may be due to the newer drug's fewer gastrointestinal side effects, researchers say.
- The study used insurance data from more than 7,000 MS patients to compare the therapies.
Despite being converted into the same active ingredient, the newer multiple sclerosis (MS) drug Vumerity (diroximel fumarate) is associated with significantly lower relapse rates than the older medication Tecfidera (dimethyl fumarate), or its generics, in people with relapsing forms of MS.
Those are the findings of a large real-world study that compared the two approved Biogen therapies using U.S. insurance claims data. The researchers had sought to determine whether there were differences in adherence and clinical outcomes between the two treatments.
Their analysis found that relapse rates among people treated continuously with Vumerity for one year were more than 20% lower than those for patients using Tecfidera or generics. Among patients with two years of follow-up data, relapse rates were more than 30% lower with Vumerity, the data showed.
For people with relapsing MS, “a significantly greater proportion … remain relapse-free over [one] year” with Vumerity versus Tecfidera, the researchers wrote.
The scientists suggested the differences may be linked to Vumerity’s better gastrointestinal tolerability, which could help patients stay on treatment more consistently.
“These findings suggest that the improved tolerability profile of [Vumerity] may contribute to improved real‐world effectiveness,” the team wrote.
The study, “Comparative Effectiveness of Diroximel Fumarate vs. Dimethyl Fumarate in Persons with Multiple Sclerosis: A US Claims Analysis of Relapse Outcomes,” was published in the journal Advances in Therapy. The research was sponsored by Biogen, which markets both medications; four of the 14 study authors are company employees.
Vumerity and Tecfidera are closely related oral therapies that belong to a class of MS medications known as fumarates. Both are taken twice daily and are converted in the body into the same active compound, which is believed to help reduce inflammation and protect nerve cells from damage.
However, the medications differ in their side effect profiles, with Vumerity generally causing fewer gastrointestinal side effects, such as nausea, abdominal pain, and diarrhea.
Tecfidera is an older medication — it’s been approved in the U.S. since 2013. Vumerity won approval as an MS treatment in 2019.
Comparing Vumerity vs. Tecfidera among over 7K patients
Vumerity’s approval was largely based on the same data that supported Tecfidera’s approval, along with studies showing that it delivers the same amount of the active ingredient while causing fewer gastrointestinal side effects.
Side effects affecting the digestive tract can make it harder for patients to remain on treatment, and research has shown that switching from Tecfidera or its generics to Vumerity improves treatment adherence. Now, the researchers aimed to explore whether this may also lead to better clinical outcomes.
“Given the critical importance of treatment adherence in chronic conditions such as MS, treatment interruptions or suboptimal adherence are strongly correlated with an increased risk of relapse and progression and undermine the therapeutic potential of the drug,” the researchers wrote.
To assess outcomes linked to the two drugs, the team turned to a large U.S. insurance claims database. The researchers identified 1,780 adults with relapsing forms of MS who continuously used Vumerity for at least one year and 5,340 patients who received Tecfidera or a dimethyl fumarate generic for the same period.
The groups were broadly similar at the start of the study. On average, the patients were about 50 years old, and approximately 80% were women. MS severity scores and the proportion of patients who experienced a relapse in the year before starting treatment were similar between the two groups.
Relapse rate over 20% lower with newer MS therapy
The analysis found that, over one year of follow-up, patients on Vumerity experienced an average of 0.12 relapses per year. Meanwhile, those on Tecfidera had 0.16 relapses per year. This meant that the annual relapse rate was 21% lower among Vumerity users, a statistically significant difference, the researchers noted.
Patients taking Vumerity were also significantly more likely to remain relapse-free throughout the study period, a finding the researchers said may indicate “an early and sustained benefit in delaying or preventing relapse onset.”
A smaller group of participants — 739 people in the Vumerity group and 2,217 in the Tecfidera group — had two years of available follow-up data. Across this period, participants on Tecfidera or generics continued to experience an average of 0.16 relapses per year. For those on Vumerity, relapse rates dropped slightly to 0.11 relapses per year.
The researchers noted that this translated to a 31% lower annualized relapse rate with Vumerity over two years.
The results of this real‐world analysis indicate [Vumerity] may be more effective than [tecfidera] in reducing relapses over [one] and [two] years of treatment in [people with] MS.
The proportion of patients who remained relapse-free over two years was also higher in the Vumerity group, but the difference did not reach statistical significance. According to the team, a possible explanation is that participants who remained on Tecfidera for two years were a select group who tolerated the drug well, thereby representing patients who may adhere better to treatment and experience the greatest benefit from the drug.
The researchers were unable to directly measure medication adherence using insurance claims data. Instead, the team assessed prescription refill coverage, finding that patients in both groups had medication available for about 82% of days during follow-up.
However, refill records do not necessarily reflect whether patients took the medication as prescribed, the team noted. For example, patients may refill prescriptions regularly but skip doses because of side effects.
As a result, the researchers said differences in actual treatment adherence remain a possible explanation for the lower relapse rates observed with Vumerity.
Altogether, “the results of this real‐world analysis indicate [Vumerity] may be more effective than [tecfidera] in reducing relapses over [one] and [two] years of treatment in [people with] MS,” the researchers concluded. However, the team noted that “additional research is warranted to corroborate these findings and further elucidate factors driving these differences in real-world effectiveness.”
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