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First long-term efficacy data of a BTK inhibitor

Presented By
Prof. Xavier Montalban , Hospital University Vall d’Hebron, Spain
Conference
ECF 2020
In the open-label extension of a phase 2 trial, the improvement in annualised relapse rate (ARR) with the Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib 75 mg twice daily (BID) at week 48 was maintained at week 108. These long-term efficacy data in patients with relapsing multiple sclerosis (MS) are the first to be reported for the class of agents that inhibits BTK. Evobrutinib targets both B cells and myeloid cells, which are known to play a key role in the pathogenesis of autoimmune diseases, such as MS. A previous phase 2, randomised controlled trial showed clinical efficacy of evobrutinib in relapsing MS, with a significant reduction of T1 Gd-enhancing lesions compared with placebo at week 24 and a continued efficacy through week 48 [1]. Of 213 patients randomised in the double-blind phase of the trial, 164 patients (77%) entered the open-label extension phase. Of them, 148 patients (90%) completed ≥108 weeks of treatment overall. At the ECF 28


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