Overview of Tolebrutinib’s Positive 18-Month Data in Relapsing MS: Jiwon Oh, MD, PhD

"Tolebrutinib is one of the BTK inhibitors that has actually shown evidence of CNS penetration. That’s a big plus. It’s also being looked at in a very comprehensive phase 3 clinical trial program. Two RRMS [trials] and one study of PPMS alone."

Tolebrutinib, an investigational Bruton tyrosine kinase (BTK) inhibitor, once again showed promise in newly presented data at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2022, held February 24-26, in West Palm Beach, Florida. In new phase 2b data, the agent demonstrated a favorable safety profile with low annualized relapse rates (ARRs) at 60-mg doses among patients with relapsing multiple sclerosis (RMS) at 18 months, a much larger time on treatment than the original 16-week trial.¹

By inhibiting BTK, tolebrutinib is designed to reduce the activation of B-cells, immune cells that play a role in the response that affects the brain and spinal cord in MS. By weeks 48 and 72, when all patients in the lower dose groups switched to 60-mg doses, investigators observed a reduction in new Gadolinium-enhancing lesions. In the original phase 2b study, tolebrutinib demonstrated a dose-dependent reduction in the number of these lesions and was well-tolerated among patients with relapsing-remitting MS or relapsing secondary progressive MS.

Lead investigator Jiwon Oh, MD, PhD, staff neurologist and medical director, Barlo Multiple Sclerosis Program, St Michaels Hospital, University of Toronto, sat down with NeurologyLive® to provide background on the study, how it was conducted, and the major take-home points clinicians of which should be aware. She also touched on the mechanism of tolebrutinib and why it has proven to be effective to this point.

REFERENCE
1. MRI, safety, and efficacy outcomes in patients with relapsing MS: 18-month results from the long-term extension study of tolebrutinib. Presented at ACTRIMS Forum 2022; February 24-26; West Palm Beach, FL. Abstract P102