VANCOUVER, British Columbia – Patients with multiple sclerosis (MS) taking ocrelizumab, an anti-CD20 B-cell-depleting humanized monoclonal antibody, are more likely to achieve no evidence of disease activity (NEDA) than those taking interferon beta-1a, researchers from the pivotal OPERA I and OPERA II phase 3 trials reported.
Analysis of the identical phase 3, randomized, 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 (AAN).
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 interferon beta-1a 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 interferon beta-1a 44 μg 3 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% and 47.5% of patients in OPERA I and OPERA II treated with ocrelizumab achieved NEDA compared to 29.2% and 25.1% of patients treated with interferon beta-1a, indicating a 64% and 89% increase (P<.0001) in patients who achieved NEDA in OPERA I and II, respectively.
In OPERA I and OPERA II, 80.4% and 78.9% of patients taking ocrelizumab vs 66.7% and 64.5% of patients taking interferon beta-1a were relapse free; 92.4% and 89.4% of ocrelizumab patients vs 87.8% and 84.9% of interferon beta-1a patients had no confirmed disability progression; 91.7% and 90.2% of ocrelizumab patients vs 69.8% and 63.9% of interferon beta-1a patients had no new or enlarging gadolinium-enhancing T1 lesions; and 61.7% and 60.9% of ocrelizumab patients vs 38.7% and 38% of interferon beta-1a patients had no new or enlarging T2 lesions.
After 24 weeks of treatment, more than 96% of patients taking ocrelizumab were without new or enlarging T2 lesions compared with 60.8% to 70.9% 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 3 times a week. This is a dramatic improvement in how we apply therapeutics to patients.”
Please refer to the presentation abstract for full faculty disclosures.
Traboulsee AL, Arnold DL, Bar-Or A, et al. Ocrelizumab no evidence of disease activity (NEDA) status at 96 weeks in patients with relapsing multiple sclerosis: analysis of the phase III double-blind, double-dummy, interferon beta-1a-controlled OPERA I and OPERA II studies. Presented at: The 68th Annual Meeting of the American Academy of Neurology; April 15-21, 2016; Vancouver, British Columbia. Abstract PL02.004.