Tolebrutinib and Teriflunomide Yield Similar Outcomes in Relapsing Multiple Sclerosis
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on June 9th, 2025
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Current therapies for multiple sclerosis (MS) primarily aim to control the inflammation that leads to white matter lesions. Among the more than 20 approved treatments, anti-CD20 monoclonal antibodies have proven effective in reducing lesion formation and preventing relapses. However, these therapies have shown limited success in halting the progression of disability. To explore alternative approaches, Sanofi sponsored a series of studies to evaluate the effectiveness of tolebrutinib in preventing relapses in patients with MS.
The phase 3 clinical trials enrolled 1,873 participants diagnosed with relapsing multiple sclerosis based on the 2017 McDonald criteria. On average, participants had experienced one relapse per year, and their mean Expanded Disability Status Scale (EDSS) score was 2.4 out of 10, indicating minimal functional impairment. Approximately 35% of participants had previously received treatment, most commonly with interferon-based therapies or glatiramer acetate.
Participants were randomly assigned to receive either tolebrutinib or teriflunomide—a well-established immunomodulator that inhibits pyrimidine synthesis required for T-cell proliferation. In contrast, tolebrutinib targets Bruton’s tyrosine kinase (BTK), which plays a key role in the activation of B cells and microglia, offering a different mechanism of action for modulating immune response in MS.
Treatment involved a daily oral dose of either 60 mg tolebrutinib or 14 mg teriflunomide. After 45 months of follow-up, the study found no clinically significant difference in the rate of disability progression between those treated with tolebrutinib and teriflunomide. However, patients receiving tolebrutinib experienced a higher incidence of minor bleeding events, such as petechiae and heavy menstrual bleeding.
The phase 3 clinical trials enrolled 1,873 participants diagnosed with relapsing multiple sclerosis based on the 2017 McDonald criteria. On average, participants had experienced one relapse per year, and their mean Expanded Disability Status Scale (EDSS) score was 2.4 out of 10, indicating minimal functional impairment. Approximately 35% of participants had previously received treatment, most commonly with interferon-based therapies or glatiramer acetate.
Participants were randomly assigned to receive either tolebrutinib or teriflunomide—a well-established immunomodulator that inhibits pyrimidine synthesis required for T-cell proliferation. In contrast, tolebrutinib targets Bruton’s tyrosine kinase (BTK), which plays a key role in the activation of B cells and microglia, offering a different mechanism of action for modulating immune response in MS.
Treatment involved a daily oral dose of either 60 mg tolebrutinib or 14 mg teriflunomide. After 45 months of follow-up, the study found no clinically significant difference in the rate of disability progression between those treated with tolebrutinib and teriflunomide. However, patients receiving tolebrutinib experienced a higher incidence of minor bleeding events, such as petechiae and heavy menstrual bleeding.