In a head-to-head comparison, natalizumab (Tysabri, Biogen) was superior to fingolimod (Gilenya, Novartis) with respect to evidence of disease activity at 1 year for patients with active relapsing-remitting multiple sclerosis (RRMS).
Use of natalizumab was associated with fewer new T2 lesions (0.7 vs 1.4 with fingolimod) and gadolinium-enhancing lesions (0.03 vs 0.5, respectively) at 12 months, for example.
"The take-home message is that natalizumab showed significant superiority compared to fingolimod on the primary outcome, which was the proportion of patients reaching NEDA [no evidence of disease activity] at 12 months," lead author Mikael Cohen, MD, told Medscape Medical News.
"The difference between both drugs was prominent on MRI parameters, especially regarding the number of gadolinium-enhancing lesions," added Cohen, of the Department of Neurology at University Hospital Center in Nice, France.
This research was presented on AAN.com as part of the 2020 American Academy of Neurology Science Highlights.
It was originally scheduled to be presented at the American Academy of Neurology (AAN) 2020 Annual Meeting in Toronto, but the conference was canceled because of the COVID-19 pandemic.
The design of the Best Escalation Strategy in MS (BEST MS) study makes it unique, Cohen said.
"It was a prospective and standardized study, unlike most other publications comparing efficacy of those two drugs that were based on retrospective analysis of data registries," he said.
Although BEST MS was an open-label, real-life analysis, the neuroradiologist who analyzed MRI images was blinded to treatment arms, he added.
The multicenter study began in France in 2013, when natalizumab and fingolimod were the two most commonly used agents for active RRMS.
Cohen and colleagues assessed 230 patients with the condition. The mean age was 38 years, and 75% were women. At the discretion of the treating physician, 113 participants received natalizumab, and 117 were treated with fingolimod.
A multivariate analysis confirmed that fingolimod was associated with a lower likelihood of achieving NEDA at 12 months.
Most relapses occurred early, and the annual relapse rate favored natalizumab, the researchers noted. In addition, the number of discontinuations due to adverse events was higher in the fingolimod group.
"We are working to submit the paper for publication," Cohen said. It has also been submitted to the ECTRIMS/ACTRIMS Joint Congress in Washington, DC, for presentation in September 2020.
More Research Warranted
Commenting on the study for Medscape Medical News, Michelle H. Cameron, MD, said the findings are difficult to interpret because "this was not a randomized controlled trial. Treatment choice was at the discretion of the providers.
"It is hard to know what biases this approach introduced ― although it is reassuring that the baseline clinical and radiographic characteristics are described as similar," said Cameron, co-director of the MS Center of Excellence West at the VA Portland Health Care System, Oregon.
In addition, the superior MRI outcomes at 12 months with natalizumab need to be backed up by clinical outcomes, she said, preferably spanning at least 2 years.
"Overall, these results seem to be consistent with the randomized controlled trials of these individual agents," Cameron concluded.
BEST MS was an institutional study and was not funded by any pharmaceutical firm. Cohen has disclosed no relevant financial relationships. Cameron is a consultant for Greenwich Biosciences and Adamas Pharmaceuticals.
American Academy of Neurology (AAN) 2020 Annual Meeting. Abstract S29 009.
Medscape Medical News © 2020
Cite this: Natalizumab Bests Fingolimod for Relapsing-Remitting MS - Medscape - May 13, 2020.