November 16, 2018

Ocrelizumab Shows Superior Outcomes in Multiple Sclerosis

By Cecilia Pessoa Gingerich
Published Online: Monday, Oct 15, 2018

New 5-year data from open-label extensions of the OPERA I, OPERA II, and ORATORIO phase 3 studies show that patients treated earlier with ocrelizumab (Ocrevus) had better outcomes on multiple measures of multiple sclerosis disease activity.

The data will be presented at the 34th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) from October 10-12 in Berlin, Germany.

“The new data presented at ECTRIMS demonstrate that Ocrevus’ efficacy continued over five years in relapsing and primary progressive MS, and notably, include the largest body of evidence for any medicine to significantly slow disability progression in primary progressive MS,” said Stephen Hauser, MD, chair of the Scientific Steering Committee of the OPERA studies, professor of neurology at the University of California, San Francisco, and director of the UCSF Weill Institute for Neurosciences. “The data also suggest that Ocrevus rapidly suppressed relapse and MRI disease activity in people with relapsing MS who switched from interferon beta-1α, and additionally, that earlier treatment with Ocrevus reduced disability progression and brain atrophy.”

In extensions of the OPERA I and OPERA II trials, participants with relapsing multiple sclerosis (RMS) who received ocrelizumab for 5 years had less brain atrophy and confirmed disability progression that those who switched to ocrelizumab after 2 years of treatment with interferon beta-1a. Patients who began treatment with ocrelizumab 2 years earlier had significant reductions in 24-week confirmed disability progression compared to patients who switched from interferon beta-1a (16.1% vs 21.3% progression after 5 years, respectively; P = .014).

In the ORATORIO trial extension, patient with primary progressive multiple sclerosis (PPMS) who were treated 3-5 years earlier had disability progression reduced by 9.6% compared to those who switched from placebo, as measured by 24-week confirmed disability progression (P = .023). Additionally, the nine-hole peg test (9-HPT) measure of upper limb disability was significantly reduced by 13.4% in those continuously treated compared to the switch group (P = .001).

The OPERA I and OPERA II trials evaluated the safety and efficacy of ocreliluzumab 600 mg administered intravenously every 6 months compared with interferon beta-1a 44 mcg administered subcutaneously 3 times per week. They were randomized, double-blind, double-dummy and included 1656 people with relapsing forms of MS, including relapsing-remitting MS and secondary progressive MS with relapses.

The ORATORIO study compared the safety and efficacy of ocrelizumab 600 mg administered intravenously every 6 months (given as two 3oo mg infusions 2 weeks apart) to placebo. The study included 732 participants with primary progressive multiple sclerosis.

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