European Committee for Treatment and Research in Multiple Sclerosis, Sept. 18-20

The annual Congress of the European Committee for Treatment and Research in Multiple Sclerosis was held from Sept. 18 to 20 in Copenhagen, Denmark, and drew more than 8,500 delegates from around the world, including clinicians and researchers in multiple sclerosis (MS). The congress highlighted the latest research in prodromal MS and radiologically isolated syndromes, neuroprotective therapies, antibody-mediated demyelinating diseases of the central nervous system, use of artificial intelligence in MS, and diversity and equity in MS, among other topics.

Data presented at the meeting from the phase 3 HERCULES trial revealed a 31 percent risk reduction in time to six-month confirmed disability progression (CDP) with tolebrutinib in patients with nonrelapsing secondary progressive MS.

Robert J. Fox, M.D., from the Mellen Center for Multiple Sclerosis at the Cleveland Clinic, and colleagues evaluated the efficacy and safety of tolebrutinib in 1,132 patients (aged 18 to 60 years; 62 percent female) with nonrelapsing secondary progressive MS from 31 countries. Patients had an Expanded Disability Scale Score of 3.0 to 6.5, documented evidence of disability progression in the previous year, and no clinical relapses during the two years before screening.

The researchers found that tolebrutinib had a significant effect on disability accumulation, with a cumulative incidence of six-month CDP of 26.9 percent compared with 37.2 percent with placebo. At six months, 10 percent of patients receiving tolebrutinib demonstrated confirmed disability improvement compared with 5.0 percent of patients who received placebo. The annualized rate of new or enlarging T2 lesions was significantly lower with tolebrutinib versus placebo (adjusted rate ratio, 0.62). Brain volume loss was low for both patient groups.

A preliminary analysis demonstrated a small increase in adverse events with tolebrutinib compared with placebo, including respiratory infections, and 4.1 percent of patients receiving tolebrutinib had liver enzyme elevations (greater than three times the upper limit of normal), but most cases resolved without sequelae.

“HERCULES is the first trial to show a slowing of disability progression in people with nonrelapsing secondary progressive MS — a population with a large unmet need,” the authors write.

Several authors disclosed ties to pharmaceutical companies, including Sanofi, which is developing tolebrutinib and funded the study.

Abstract

In another presentation, Wallace Brownlee, M.B.Ch.B., Ph.D., of the University College London, and colleagues evaluated the performance of the 2017 McDonald relapsing-remitting MS (RRMS) and primary progressive MS (PPMS) dissemination in space (DIS) and time (DIT) criteria in patients with PPMS and two modified DIS criteria: optic nerve lesions in DIS and at least two spinal cord lesions, irrespective of brain magnetic resonance (MRI) imaging findings.