Update: On March 28, 2017, Ocrevus (ocrelizumab) was approved by the FDA to or the treatment of primary progressive and relapsing multiple sclerosis. For more information, read this article about the FDA approval.
Results from the ORATORIO study, a pivotal Phase 3 study evaluating investigational drug ocrelizumab, demonstrated efficacy in people with primary progressive multiple sclerosis (PPMS). Treatment with Roche’s ocrelizumab significantly reduced progression of sustained clinical disability (measured by the Expanded Disability Status Scale [EDSS]) for at least 12 weeks when compared with placebo. Safety data from the study were also promising, as the overall incidence of adverse events for those receiving ocrelizumab were similar to those receiving placebo, with the most common adverse events being mild-to-moderate infusion-related reactions.
There are currently no approved treatments for people with primary progressive MS, making ocrelizumab the first investigational drug to demonstrate clinically meaningful effect on disease progression in PPMS. ORATORIO is a randomized, double-blind, global multi-center study that examined the efficacy and safety of 600 mg ocrelizumab by IV infusion every 6 months given as two 300 mg infusions, 2 weeks apart. These data will be presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October. Additionally, positive results from phase 3 studies of ocrelizumab (OPERA I and OPERA II) in people with relapsing-remitting MS will be presented.
Results from the ORATORIO study are exciting, and hold promise for the potential of an approved treatment for those living with PPMS. 1-3
F. Hoffmann-La Roche. ClinicalTrials.gov NCT01194570. National Library of Medicine. Available at: https://clinicaltrials.gov/ct2/show/NCT01194570.
F. Hoffmann-La Roche. ClinicalTrials.gov NCT01247324 and NCT01412333. National Library of Medicine. Available at: https://clinicaltrials.gov/ct2/show/NCT01247324 and https://clinicaltrials.gov/ct2/show/NCT01412333.
Roche's ocrelizumab first investigational medicine to show efficacy in people with primary progressive multiple sclerosis in large Phase III study. Fierce Biotech. September 28, 2015. Available at: http://www.fiercebiotech.com/press-releases/roches-ocrelizumab-first-investigational-medicine-show-efficacy-people-prim.