(HealthDay News) — Ocrelizumab, a new and fully humanized monoclonal anti-CD20 antibody that causes B-cell depletion, is associated with lower relapse rate and lower rates of progression among patients with relapsing or primary progressive multiple sclerosis, respectively, according to research published online Dec. 21 in the New England Journal of Medicine.
Stephen L. Hauser, M.D., from the University of California, San Francisco, and colleagues randomized 821 and 835 patients with relapsing multiple sclerosis to receive intravenous ocrelizumab every 24 weeks or subcutaneous interferon beta-1a three times weekly for 96 weeks in two identical phase 3 trials. The researchers found that the annualized relapse rate was lower with ocrelizumab than interferon beta-1a in trials 1 and 2 (46 and 47 percent lower, respectively; both P < 0.001). The percentage of patients with disability progression confirmed at 12 and 24 weeks was significantly lower with ocrelizumab (hazard ratios, 0.60 [P < 0.001] and 0.60 [P = 0.003], respectively).
Xavier Montalban, M.D., Ph.D., from the Hospital Vall d’Hebron University in Barcelona, Spain, and colleagues conducted a phase 3 trial involving 732 patients with primary progressive multiple sclerosis to receive intravenous ocrelizumab or placebo every 24 weeks for 120 weeks. The researchers found that 32.9 and 39.3 percent of patients treated with ocrelizumab and placebo had 12-week confirmed disability progression, respectively (hazard ratio, 0.76; P = 0.03). The percentage of patients with 24-week confirmed disability progression was 29.6 and 35.7 percent, respectively (hazard ratio, 0.75; P = 0.04). There was a 3.4 percent decrease and a 7.4 percent increase with ocrelizumab and placebo, respectively, in the total volume of brain lesions on T2-weighted magnetic resonance imaging (MRI).
“Ocrelizumab was associated with lower rates of clinical and MRI progression than placebo,” Montalban and colleagues write.
Several authors from both studies disclosed financial ties to pharmaceutical companies, including F. Hoffmann-La Roche, which manufactures ocrelizumab and funded the studies.