Early Initiation of Ocrelizumab Reduces MS Disability Progression Over 5 Years
OCTOBER 10, 2018
Cecilia Pessoa Gingerich
Stephen L. Hauser, MDNew 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.
Credit: UCSF Medical Center
Credit: UCSF Medical Center
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.
The ocrelizumab Prescribing Information lists upper respiratory tract infections and infusion reactions as the most common adverse reactions (incidence >10% and greater than interferon beta-1a) in patients with relapsing multiple sclerosis. The most common adverse reactions in patients with primary progressive multiple sclerosis (occurring in ≥10% of patients and greater than placebo) were upper respiratory tract infections, infusion reactions, skin infections, and lower respiratory tract infections.
Ongoing safety data—encompassing 3811 RMS and PPMS patients and 10,919 patients years of exposure to ocrelizumab—to be presented at ECTRIMS is consistent with ocrelizumab’s previously reported benefit-risk profile.
Ocrelizumab became the first approved drug indicated for primary progressive multiple sclerosis when the US Food and Drug Administration (FDA) approved it in March 2017 for both PPMS and RMS.