For multiple sclerosis (MS) patients with considerable disability, Ocrevus (ocrelizumab) appears to lower the risk of continued progression in both relapsing and primary progressive forms of the disease, data from an exploratory and post-hoc analysis of three Phase 3 trials report.
These findings were in the study, “An exploratory analysis of the efficacy of ocrelizumab in patients with multiple sclerosis with increased disability,” published in the Multiple Sclerosis Journal – Experimental, Translational and Clinical.
Ocrevus, developed and marketed by Genentech, a subsidiary of Roche, is a monoclonal antibody that targets CD20, a protein found on the surface of immune B-cells. It works to lower the activity of the immune system (immunosuppressive agent) to prevent immune cells from attacking nerve cells, triggering MS onset and progression.
Previous Phase 3 trials assessing the safety and efficacy of Ocrevus, including OPERA I (NCT01247324), OPERA II (NCT01412333), and ORATORIO (NCT01194570), showed that Ocrevus reduced disease progression in people with relapsing forms of MS — relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) — as well as in those with PPMS.
“In these trials, ocrelizumab treatment was associated with lower rates of disease activity and progression than interferon (IFN) β-1a [Rebif] treatment in patients with RMS [relapsing MS] and reduced rates of clinical and magnetic resonance imaging–measured disease progression compared with placebo in patients with PPMS,” the researchers wrote.
An exploratory analysis of these three trials was done to assess Ocrevus’ effectiveness in slowing disability progression in those enrolled patients who were considerably or highly disabled.
That is, the group of 882 relapsing MS and PPMS patients who entered these studies with an Expanded Disability Status Scale (EDSS) score of 4.0 or greater (significant disability but self-sufficiency), including 88 PPMS patients who at baseline had EDSS scores of 6.0 or greater (severe disability requiring walking aids).
In the OPERA trials, relapsing MS patients were treated either with Ocrevus at a dose of 600 mg intravenously every 24 weeks (six months), or Rebif at a dose of 44 mcg subcutaneously (under-the-skin injections) three times weekly, for 96 weeks (about 1.8 years).
In ORATORIO, PPMS patients were treated with either Ocrevus at the same dose and schedule as OPERA, or were given a placebo for at least 120 weeks (about 2.3 years).
Data in the analysis covered 375 relapsing patients who participated in the OPERA trials, and 507 with PPMS who participated in ORATORIO. All, again, had EDSS scores of 4.0 or greater.
Patient baseline demographics, disease clinical features, and treatment characteristics were similar among the different treatment groups in all three trials.
Among the relapsing MS patients with considerable disabled (EDSS of 4.0 or more) in the OPERA trials, Ocrevus led to significant reductions in confirmed disability progression (CDP) on EDSS (CDP-EDSS). In this analysis, CDP was defined as an increase of at least 1.0 point in EDSS scores for those with a baseline EDSS score lower than 5.5, and an increase of at least a 0.5 point for those with starting EDSS scores greater than 5.5.
Similar reductions in CDP-EDSS were seen for those participating in ORATORIO who had a baseline EDSS score of 4.0 or greater.
Taken together, the exploratory results showed that “in patients with increased baseline disability, ocrelizumab reduced the risk of confirmed disability progression versus interferon β-1a in patients with relapsing-onset MS, and versus placebo in patients with progression-onset MS,” the researchers wrote.
But, they continued, “due to the exploratory nature of this analysis, additional prospective studies are warranted to assess treatment benefit in patients with MS with advanced disease using qualified, sensitive, and meaningful assessments of disability.”
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