Positive Results from Phase 2 Clinical Trials of Evobrutinib for Multiple Sclerosis

 

After 24 weeks of treatment, patients treated with 75 mg of evobrutinib (EMD Serono, Rockland, MA) 2 or 4 times per day had significantly fewer T1 gadolinium-enhancing (Gd+) lesions compared with patients given placebo (P = .0313 for 1 dose/day, P =.0015 for 2 doses/day). Patients treated with 25 mg once per day did not have a reduction in Gd+ lesions compared with those given placebo (P = .295). A dose-response relationship was seen (P = .01) and, although not statistically significant, there was a trend towards reduced annual relapse rate. 

The rate of adverse events was comparable in patients given 25 mg or 75 mg evobrutinib once daily was comparable to that seen with placebo. Patients treated with 75 mg twice daily had more adverse events, mainly elevated liver enzymes. No Hy’s Law cases occurred and there were no serious infections or other emerging safety signals.

Evobrutinib is a specific, irreversible inhibitor of Bruton’s tyrosine kinase that impairs B cell and macrophage activation in vivo. In this randomized, double-blind study (NCT02975349), patients in the trial were adulst age 18 to 65 years with relapsing remitting multiple sclerosis (MS) or secondary progressive MS with superimposed relapses. These data were presented at the American Conference on Treatment and Research in MMS (ACTRIMS) conference in Dallas, TX February 28-March 1. 

 

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