FAQs about evobrutinib in MS

Evobrutinib inhibits Bruton’s tyrosine kinase (BTK), a protein involved in the development and maturation of immune cells, including B-cells. These cells play a major role in driving the inflammation that damages the nervous system in multiple sclerosis (MS). By inhibiting BTK, the investigational therapy may slow or even halt neurodegeneration in people with MS.

Evobrutinib has shown promising results in a Phase 2 trial. These findings supported the launch of two Phase 3 studies to confirm the therapy’s benefits in relapsing forms of multiple sclerosis. Top-line data from these trials are expected in late 2023 and both are estimated to finish in June 2026. However, it is too early to know if or when the therapy might be approved by the U.S. Food and Drug Administration.

It is not known whether the therapy is safe for use during pregnancy, as clinical trials of evobrutinib did not include pregnant or breastfeeding patients. In fact, among the trials’ criteria were that participants be neither pregnant nor breastfeeding, and/or lack child-bearing potential (defined as being post-menopausal or surgically sterile), or use effective contraception methods while on the study and at least two years after its completion. Patients should talk with their healthcare team if they become pregnant, plan to become pregnant, or are breastfeeding or plan to do so while on evobrutinib.

In clinical trials in MS patients, the earliest results of evobrutinib’s effects — a significant reduction in the number of brain lesions — were reported after about six months of treatment (24 weeks). The study also reported no relapses in 79% of patients treated for about one year (48 weeks) at the highest dose tested (75 mg, twice daily).

Neither hair loss nor weight gain have been reported as side effects of evobrutinib in multiple sclerosis clinical trials. However, in trials with another Bruton’s tyrosine kinase inhibitor, called tolebrutinib, hair loss was a reported side effect of the therapy’s use in a Phase 2 trial. Patients who experience unexpected effects after starting a new therapy should talk to their healthcare providers.

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