Early and continuous treatment with Ocrevus (ocrelizumab) leads to a greater and more durable slowing of disability progression — seen for up to 6.5 years — in people with primary progressive multiple sclerosis (PPMS), according to long-term data on its use in PPMS patients in a Phase 3 main and extension study.
Findings showed that Ocrevus, started early, results in less disability accumulation over time, and can offer protection from becoming wheelchair dependent that extends out years.
These follow-up data led its presenter to conclude, “It would be some time before these results can be challenged.”
Results were given by Jerry S. Wolinsky, MD, a neurologist and professor at McGovern Medical School in Houston, in the oral presentation “Sustained reduction in confirmed disability progression in patients with primary progressive multiple sclerosis treated with ocrelizumab in the open-label extension period of the Phase III ORATORIO trial: 6.5-study year follow-up data,” shared at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held Sept. 11–13 in Stockholm.
Ocrevus’ benefit in PPMS was demonstrated in the Phase 3 ORATORIO trial (NCT01194570; a study funded by Roche, which owns Genentech, Ocrevus’ manufacturer). The therapy was shown to also lead to lower rates of disease progression, and to help preserve hand and arm function.
ORATORIO was a randomized, double-blind, and placebo-controlled 120-week study involving 732 PPMS patients (ages 18–55).
Wolinsky and colleagues looked at the results of the open-label extension study that followed the ORATORIO trial (opening between 140 and 240 weeks after the main trial’s start). In this extension, all were given Ocrevus — those who had been on placebo switched to Ocrevus, and those who had been on Ocrevus continued with the treatment.
Combining both data — from the double-blind study and its open-label extension — the team’s goal was to assess Ocrevus’ efficacy in terms of time to onset of confirmed disability progression (CDP) in patients maintaining or switching to Ocrevus therapy.
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