“The data shared at AAN represent our ongoing efforts to improve the MS treatment experience and deliver therapies that provide clinically meaningful benefits to individuals living with this chronic disease,” Bernd Kieseier, MD, said in a press release. Kieseier is executive director, head of Global MS, Worldwide Medical, Biogen.
In EVOLVE-MS-2, participants with relapsing-remitting MS (RRMS) were assigned randomly to treatment with either Tecfidera (240 mg) or Vumerity (462 mg) for five weeks. These two oral medications are different formulations of the same active ingredient — monomethyl fumarate. The main purpose of the trial was to compare the safety and tolerability of the two therapies, especially regarding gastrointestinal side effects.
Among 502 participants who rated their gastrointestinal (GI) symptoms at least once, fewer patients receiving Vumerity, compared to Tecfidera, reported that GI symptoms interfered with daily life “quite a bit” or “extremely.”
The specific symptoms were: nausea (2.4% with Vumerity vs. 6.8% with Tecfidera), vomiting (1.2% vs. 5.6%), upper abdominal pain (1.2% vs. 6.8%), lower abdominal pain (1.2% vs. 3.2%), and diarrhea (3.6% vs. 6.4%).
Also, treatment discontinuation due to GI symptoms was significantly lower with Vumerity (0.8%) than with Tecfidera (4.8%).
“GI symptoms interfered less with daily activities for [Vumerity]-treated patients compared to [Tecfidera]. Further benefits on additional measures of treatment burden, including lower medication use for GI symptoms, were seen with [Vumerity],” the researchers wrote.
Participants who completed EVOLVE-MS-2 had the option to enroll in EVOLVE-MS-1, an open-label extension study in which all participants were treated with Vumerity.
Currently, 82 participants have completed 48 weeks in EVOLVE-MS-1, representing about a year of total treatment.
Data now released showed that the mean number of brain MRI lesions was 1.1 prior to treatment, and was significantly reduced to 0.2 after one year of treatment with Vumerity, with 96.3% of participants being lesion-free. Significant lesion reductions were observed as early as seven weeks after starting treatment.
Three other Biogen AAN presentations focused on Tysabri. This medication is currently approved to be given by injection once every four weeks (Q4W), but extended interval dosing (EID) — in which injections are given about every six weeks — is being evaluated as a possible way to limit side effects.
This analysis included 79 people with RRMS who were given the Q4W dosing schedule and 60 people who switched to EID. Levels of NfL were not significantly different between these dosing schedules.
“Patients in real-world clinical practice who switched from natalizumab Q4W to EID showed no increase in sNfL levels, supporting previous reports that EID is not associated with increased disease activity,” the researchers wrote.
Tysabri is known to potentially increase the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection. Using data from a Tysabri prescribing database (TOUCH), which included tens of thousands of treated patients, researchers confirmed previous data and showed that Tysabri EID was associated with a reduced PML risk compared to Q4W.
“This stabilization coincides with the publication of new PML risk estimates, suggesting that risk stratification factors are being incorporated into clinical practice and may continue to impact PML incidence in the future,” the researchers wrote.
Of note, some of these PML risk factors include the presence of anti-JC virus antibodies (JC virus is the agent causing PML), prior immunosuppressant use, and longer treatment duration.
The highest recorded Plegridy concentration in breast milk was 126.2 picogram (pg)/mL; average values were 56.9 pg/mL after five days and 27.4 pg/mL after 14 days. Of note, in a previous study using Avonex (intramuscular interferon beta-1a ), the highest observed breast milk concentration was 179 pg/mL, with an estimated relative infant dose of 0.006%.
“These findings may be useful for clinicians considering postpartum treatment options for patients with MS,” the researchers wrote.
Overall, the data presented at AAN “demonstrate the strength of our portfolio and Biogen’s commitment to enhancing the care of individuals with relapsing MS,” Kieseier concluded.
Marisa holds an MS in Cellular and Molecular Pathology from the
University of Pittsburgh, where she studied novel genetic drivers of
ovarian cancer. She specializes in cancer biology, immunology, and
genetics. Marisa began working with BioNews in 2018, and has
written about science and health for SelfHacked and the Genetics
Society of America. She also writes/composes musicals and coaches
the University of Pittsburgh fencing club.
Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
Marisa holds an MS in Cellular and Molecular Pathology from the
University of Pittsburgh, where she studied novel genetic drivers of
ovarian cancer. She specializes in cancer biology, immunology, and
genetics. Marisa began working with BioNews in 2018, and has
written about science and health for SelfHacked and the Genetics
Society of America. She also writes/composes musicals and coaches
the University of Pittsburgh fencing club.