Vumerity (diroximel fumarate) is easier on the gastrointestinal tract than Tecfidera (dimethyl fumarate), and this translates into better quality of life for patients with relapsing-remitting multiple sclerosis (RRMS), a new analysis of EVOLVE-MS-2 trial data has found.
The study, “Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study,” was published in the journal Therapeutic Advances in Neurological Disorders.
Vumerity (previously BIIB098 and ALKS8700) is an oral delayed-release capsule marketed by Biogen that is approved for the treatment of relapsing forms of multiple sclerosis in adults. It has the same active metabolite (product resulting from the body’s chemical processes) as Tecfidera — another approved oral medicine for relapsing forms of multiple sclerosis, also marketed by Biogen.
The safety and tolerability of Vumerity was previously compared with Tecfidera in a five-week, randomized Phase 3 clinical trial called EVOLVE-MS-2 (NCT03093324). The results of the trial showed that Vumerity carries fewer and milder gastrointestinal side effects than Tecfidera.
Now, researchers have made a new analysis of the data collected during the EVOLVE-MS-2 study. The goal was to assess not only the degree to which patients tolerated gastrointestinal side effects, but how these affected their quality of life.
“Patients value their overall well-being and minimal treatment burden,” the researchers wrote.
To be eligible for the study, patients had to have a confirmed diagnosis of RRMS and no history of gastrointestinal symptoms. In total, 504 patients were analyzed; of those, 253 received Vumerity (231 mg twice daily in week 1, and 462 mg twice daily in weeks 2–5) and 251 received Tecfidera (120 mg twice daily in week 1, and 240 mg twice daily in weeks 2–5).
The team assessed treatment-related gastrointestinal adverse events on a weekly basis.
Consistent with the results of the initial study, patients taking Vumerity experienced fewer gastrointestinal tolerability adverse events than patients taking Tecfidera — 34.8% compared with 48.2%. These events were also less severe, with 7.9% of gastrointestinal adverse events being reported as moderate or severe in patients taking Vumerity versus 18.7% in patients taking Tecfidera.
Among patients who had gastrointestinal adverse events, those taking Vumerity made less use of medication to relieve gastrointestinal symptoms than those taking Tecfidera — 19.3% compared with 30.6%.
As part of the study, patients tracked their own gastrointestinal symptoms daily using two self-reported questionnaires: the individual gastrointestinal symptom and impact scale (IGISIS) and the global gastrointestinal symptom and impact scale (GGISIS).
A smaller proportion of patients taking Vumerity (43.1%) reported an IGISIS score equal to or above 2 at any time in the treatment period — ranking nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea — compared with patients taking Tecfidera (51.4%).
Furthermore, fewer patients taking Vumerity had gastrointestinal symptoms that interfered with their regular daily activities (9.5% versus 28.9%) and work productivity (6.1% versus 11.3%) compared with patients taking Tecfidera, as assessed using the GGISIS.
Patients taking Vumerity also missed fewer hours of work than patients taking Tecfidera — 43 days with one or more hours of work missed versus 88 days in the Tecfidera group.
In patients taking Vumerity, the severity of gastrointestinal symptoms decreased over the course of the five weeks of the study, suggesting “patients may better tolerate the transition from titrated to full dose (231–462 mg twice daily), enabling patients to initiate [Vumerity] as per the approved instructions and achieve the full efficacy benefit sooner.”
Finally, a lower proportion of patients stopped taking Vumerity due to gastrointestinal-related symptoms — 0.8% of those taking Vumerity stopped treatment compared with 4.8% of those taking Tecfidera.
Overall, Vumerity’s better gastrointestinal tolerability profile “translated into clinically meaningful benefits to [quality of life], as patients experienced less impact on daily life and work and required less concomitant symptomatic medication use,” the researchers concluded.
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