From the American Academy of Neurology 59th Annual Meeting: BENEFIT: Rituximab offers early promise in the treatment of RRMS

Rituximab, which is currently FDA-approved for the treatment of certain B-cell lymphomas and moderate-to-severe rheumatoid arthritis, demonstrated benefit in the treatment of relapsing-remitting multiple sclerosis (RRMS) in 2 early-phase experimental trials.

Key Points

Rituximab, which is currently FDA-approved for the treatment of certain B-cell lymphomas and moderate-to-severe rheumatoid arthritis, demonstrated benefit in the treatment of relapsing-remitting multiple sclerosis (RRMS) in 2 early-phase experimental trials. In both studies, the drug was associated with reduced magnetic resonance imaging (MRI) disease activity in RRMS.

The efficacy of rituximab in these trials suggests that B cells play a role in mediating relapses of MS because rituximab is a therapeutic antibody that targets and selectively depletes CD20-positive B cells, said Stephen Hauser, MD, chair of the department of neurology, University of California, San Francisco.

The overall incidence of adverse events was comparable between the 2 groups, except for an excess of infusion-associated adverse events in the rituximab group compared with placebo (78.3% vs 40.0%, respectively).

The second study, a phase 1 study, was an open-label trial of 26 patients who received two 1,000-mg infusions of rituximab administered 2 weeks apart, followed by another course 6 months later. At 48 weeks, the number of new gadolinium-enhancing lesions was reduced by >90% compared with baseline, an effect that was already evident at Week 4, reported Amit Bar-Or, MD, of the Montreal Neurological Institute at McGill University in Montreal, Canada.

A total of 3 relapses were observed among all patients in the study, representing an annualized relapse rate of 0.13 (patients had to have ≥1 relapse in the prior year to be eligible for the study).