Ocrevus (ocrelizumab) significantly reduces disease activity and disability progression in patients with relapsing multiple sclerosis (MS) and primary progressive MS (PPMS), according to results of post-hoc analyses of Genentech’s Phase 3 clinical trial program assessing the drug.
Results will be presented at the upcoming 3rd Congress of the European Academy of Neurology (EAN), June 24-27, in Amsterdam, Netherlands.
By revisiting the data from completed clinical trials, researchers assessed a new endpoint considered to be clinically relevant: the “No Evidence of Progression or Active Disease” (NEPAD).
NEPAD means that a patient has no relapses; no confirmed disability progression measured by the Expanded Disability Status Scale (EDSS); no progression equal to or above 20% on the timed 25-foot walk (a mobility and leg function performance test) and the nine-hole peg test (a measure of finger dexterity); and no disease activity in the brain measured through magnetic resonance imaging (MRI).
An analysis of the pooled data from the Phase 3 OPERA I (NCT01247324) and OPERA II (NCT01412333) trials of Ocrevus for treating relapsing MS patients showed that the number of Ocrevus-treated patients who had maintained NEPAD at 96 weeks after treatment was 82% higher than that of patients treated with Rebif (interferon beta-1a), a therapeutic option for MS.
In PPMS, an analysis of the Phase 3 ORATORIO trial (NCT01194570) found that more than three times the number (29.9%) of patients with PPMS treated with Ocrevus maintained NEPAD at 120 weeks compared to patients receiving a placebo (9.4%).
Ocrevus was also found to reduce the risk of MS patients requiring mobility aids. At 96 weeks, patients with relapsing MS who received Ocrevus had a reduced risk of losing the ability to walk long distances unassisted or requiring a cane or crutch compared to patients treated with Rebif. In patients with PPMS, Ocrevus reduced the risk of becoming wheelchair-bound, assessed at 120 weeks, compared to a placebo.
Genentech trials also revealed that Ocrevus reduced the risk of more severe forms of disability progression, assessed through the 12- and 24-week confirmed disability progression (CDP) measure.
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