The Bruton’s Tyrosine Kinase inhibitors (BTKi) are a new class of medications being studied for use in both relapsing and progressive MS patients, and recent data published by one of the manufacturers indicated some positive results.
BTKi are once-per-day, oral enzyme inhibitors that hold the promise of decreasing pro-inflammatory function in both B lymphocytes and microglia. The latter are immune cells that live in the brain and spine, and appear to play a large role in progressive MS. Several drugs in this class are in Phase 3 of development in both relapsing and progressive MS patients.
The first results in relapsing MS came out in December 2023, and showed that the drug Evobrutinib was no better than Teriflunomide (Aubagio) in reducing the annualized relapse rate in relapsing MS.
For a more comprehensive update on the progress of BTK inhibitors, please register for the MS Center’s Fall 2024 Education Summit, coming up on Saturday, Nov. 16, where Dr. Enrique Alvarez is scheduled to present on this topic.
Earlier this month, Sanofi announced via a press release the top-line results of both their relapsing and some of their progressive MS studies with Tolebrutinib. In relapsing patients again, Tolebrutinib was no better than Teriflunomide (Aubaugio) regarding the risk of relapse, but there was a significant delay in time to progression of disability accumulation. More importantly, in those with non-relapsing secondary progressive MS (that is, without recent relapses), there also was a significant delay in time to progression of disability. Thus, in both younger patients with relapsing MS and somewhat older patients with non-relapsing secondary progressive MS, Tolebrutinib significantly delayed the time to accumulate worsened disability.
As with all studies, we await the details, especially as they relate to the size of the effect seen and the safety. In these studies, Tolebrutinib and other members of this class of drugs have been associated with a very small number of individuals with significant liver disease. These details will be reported at the European Committee on Treatment and Research In MS (ECTRIMS) meeting in mid-September in Copenhagen, Denmark.
We will continue to update you with further information on these studies.