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      EAN Congress news EAN Student Task Force – local involvement project in 2025 

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      Research Papers of the Month: Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis / Tolebrutinib versus Teriflunomide in Relapsing Multiple Sclerosis

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      Advocacy

      Draft Innovative Health Initiative (IHI) Funding Call topics related to the brain

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      Draft Innovative Health Initiative (IHI) Funding Call topics related to the brain

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      Student Corner Photo of a sheet of paper, pencil and crumpled paper on a desk.

      Why Neurology? Read some compelling answers from our EAN 2025 essay contest winners!

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EANnews

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      EAN Congress news EAN Student Task Force – local involvement project in 2025 

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      May 22, 2025

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      April 11, 2025

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      March 13, 2025

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      Executive Page: “on a Brain Mission” – EAN Treasurer on her first six months in office

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      EAN News

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      May 13, 2025

      EAN News Public Brain Health Day in white text on a green and blue coloured background

      Public Brain Health Day at the EAN Congress 2025 in Helsinki

      May 8, 2025

      EAN News large group of course participants posing on internal stairway

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      May 8, 2025

      EAN News

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      May 7, 2025

      EAN Congress news EAN Student Task Force – local involvement project in 2025 

      EAN Student Task Force – local involvement project in 2025 

      May 22, 2025

      EAN Congress news

      A chance to connect, learn, and grow – join our mentorship workshop at the EAN Congress 2025

      May 12, 2025

      EAN Congress news Photo of a sheet of paper, pencil and crumpled paper on a desk.

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      May 12, 2025

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      May 8, 2025

      Interviews

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      March 14, 2025

      Interviews

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      January 15, 2025

      Interviews

      Video interview: Claudia Sommer, incoming Editor-in-Chief of the European Journal of Neurology

      January 3, 2025

      Interviews

      Video interviews: meet some of the EAN’s national neurological society partners!

      November 20, 2024

  • Research
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      May 13, 2025

      Paper of the Month

      Research Papers of the Month: Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis / Tolebrutinib versus Teriflunomide in Relapsing Multiple Sclerosis

      May 7, 2025

      Advocacy

      Draft Innovative Health Initiative (IHI) Funding Call topics related to the brain

      May 2, 2025

      Advocacy 'Horizon Europe' in large 3D text, surrounded by illustrations of people undertaking various activities

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      May 2, 2025

      Research Funding

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      May 2, 2025

      Research Funding 'Horizon Europe' in large 3D text, surrounded by illustrations of people undertaking various activities

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      Research Highlights

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      May 13, 2025

      Research Highlights

      Research Highlights of the Month – April 2025

      April 14, 2025

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      Research Highlights

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      February 14, 2025

      Paper of the Month

      Research Papers of the Month: Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis / Tolebrutinib versus Teriflunomide in Relapsing Multiple Sclerosis

      May 7, 2025

      Paper of the Month

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      April 4, 2025

      Paper of the Month

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      March 14, 2025

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  • Education
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      May 12, 2025

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      May 12, 2025

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      May 8, 2025

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      March 27, 2025

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      March 6, 2025

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      May 12, 2025

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      August 23, 2024

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  • Other News
    • All EAN Staff EBC News in general Surveys
      Brain Health

      Yaoundé Declaration on the brain economy officially launched

      May 12, 2025

      EBC Composite image containing various photos from European Brain Council events, plus the EBC logo

      EBC launches 2024 annual report

      April 25, 2025

      Other News

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      April 15, 2025

      Brain Health

      Brain Innovation Days announces theme and subtheme for 2025 edition!

      March 29, 2025

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      August 3, 2023

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      April 25, 2025

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      Brain Innovation Days announces theme and subtheme for 2025 edition!

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      November 25, 2024

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      January 31, 2025

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      January 31, 2025

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      March 5, 2024

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      August 3, 2023

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Paper of the MonthEAN NewsFeatured Slider

Research Papers of the Month: Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis / Tolebrutinib versus Teriflunomide in Relapsing Multiple Sclerosis

May 7, 2025

by Isabella Colonna

For May we have selected two closely related papers as co-papers of the month:

Fox RJ, Bar-Or A, Traboulsee A, Oreja-Guevara C, Giovannoni G, Vermersch P, Syed S, Li Y, Vargas WS, Turner TJ, Wallstroem E, Reich DS; HERCULES Trial Group. Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis. N Engl J Med. 2025 Apr 8. doi: 10.1056/NEJMoa2415988. Epub ahead of print. PMID: 40202696.

Oh J, Arnold DL, Cree BAC, Ionete C, Kim HJ, Sormani MP, Syed S, Chen Y, Maxwell CR, Benoit P, Turner TJ, Wallstroem E, Wiendl H; Tolebrutinib Phase 3 GEMINI 1 and 2 Trial Group. Tolebrutinib versus Teriflunomide in Relapsing Multiple Sclerosis. N Engl J Med. 2025 Apr 8. doi: 10.1056/NEJMoa2415985. Epub ahead of print. PMID: 40202623.

Isabella Colonna

These two papers present findings from recent phase 3 clinical trials evaluating the efficacy and safety of tolebrutinib, an oral and brain-penetrant Bruton’s tyrosine kinase inhibitor, in patients with multiple sclerosis.

The first paper presents the results of a phase 3, double-blind, placebo-controlled trial (HERCULES), designed to evaluate the efficacy and safety of tolebrutinib in patients with non-relapsing secondary progressive multiple sclerosis. A total of 1131 participants were randomised to receive either tolebrutinib 60 mg once daily (n=754)  or a matching placebo (n=377), with a median follow-up of 133 weeks. The percentage of patients with confirmed disability progression sustained for at least 6 months was statistically significantly lower in the tolebrutinib group than in the placebo group (22% vs 30.7%, p=0.003). Similarly, significant differences favouring the tolebrutinib group were observed in the 24-month Kaplan−Meier estimates, the percentage of participants with 3-month confirmed disability progression, and the mean annualised rate of new or enlarging lesions on T2-weighted MRI. Serious adverse events occurred in 15% and 10.4% of participants in the tolebrutinib and placebo group respectively, while the incidence of death was similar in the two groups.

The second paper reports the results of two phase 3, double-blind, double-dummy, trials (GEMINI 1 and GEMINI 2) evaluating the efficacy and safety of tolebrutinib compared with teriflunomide in patients with relapsing multiple sclerosis. A total of 1873 participants were randomised to receive tolebrutinib 60 mg (n=933) or teriflunomide 14 mg (n=940), with a median follow-up of 139 weeks. No significant differences were found between groups for the annualised relapse rate (primary outcome) as well as for the number of acute inflammatory brain lesions on MRI. Although fewer participants in the tolebrutinib group experienced confirmed disability worsening sustained for at least 3 and 6 months compared to the teriflunomide group, this finding could not be confirmed due to termination of the hierarchical testing procedure. The incidence of adverse events was similar between the two groups.

In conclusion, tolebrutinib was associated with a lower risk of disability progression in patients with non-relapsing secondary progressive multiple sclerosis, whereas it did not demonstrate superiority over teriflunomide in reducing annualised relapse rates in patients with relapsing multiple sclerosis.


Research Papers of the Month: Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis / Tolebrutinib versus Teriflunomide in Relapsing Multiple Sclerosis was last modified: May 14th, 2025 by Simon Lee
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