Patients with multiple sclerosis (MS) taking Ocrelizumab are more likely to achieve no evidence of disease activity (NEDA) than those taking beta interferon, researchers from the pivotal OPERA I and OPERA II phase III trials have reported.
Analysis of the identical phase III, randomised, double-blind, double-dummy clinical trials was presented during the Clinical Trials Plenary session at the 2016 annual meeting of the American Academy of Neurology in Canada.
NEDA — a composite measure defined as no MS relapses, no confirmed disability progression, and no new or enlarging T2 lesions or gadolinium-enhancing T1 lesions — is increasingly becoming the treatment goal in MS.
In order to compare the effect of Ocrelizumab vs beta interferon on the achievement of NEDA, patients in both trials were randomly assigned to receive either ocrelizumab 600 mg via intravenous infusion every 24 weeks or subcutaneous beta interferon three times per week over 96 weeks. NEDA was assessed over the duration of the study, with magnetic resonance imaging (MRI) conducted at 24, 48, and 96 weeks.
Each trial included 828 patients with relapsing-remitting MS. At 96 weeks, 47.9 per cent and 47.5 per cent of patients in OPERA I and OPERA II treated with Ocrelizumab achieved NEDA compared to 29.2 per cent and 25.1 per cent of patients treated with beta interferon, indicating a 64 per cent and 89 per cent increase in patients who achieved NEDA in OPERA I and II, respectively.
After 24 weeks of treatment, more than 96 per cent of patients taking Ocrelizumab were without new or enlarging T2 lesions compared with 60.8 to 70.9 per cent of patients taking interferon beta-1a.
“Safety has been quite good and efficacy across all measurements, including brain atrophy and disability, has been outstanding,” lead investigator Anthony L. Traboulsee, MD, FRCPC, director of UBC Hospital's MS and NMO Clinic, associate professor of UBC Faculty of Medicine, and MS Society of Canada Research Chair, told Neurology Advisor.
“One truly exciting thing for patients with this type of treatment approach is the confidence of high efficacy as well as the convenience,” he said.
“You only have to take this treatment twice a year, compared with taking a pill every day or using a needle three times a week. This is a dramatic improvement in how we apply therapeutics to patients.”
Source: Neurology Advisor Copyright © 2016 Haymarket Media, Inc (22/04/16)