Long-term treatment with Ocrevus (ocrelizumab) — as well as switching from Rebif (interferon beta-1a) to Ocrevus — leads to a significant and sustained reduction in disease activity in relapsing forms of multiple sclerosis (MS).
These previously reported findings are further supported by the latest results drawn from pooled data from the open-label extension studies of the Phase 3 OPERA I and OPERA II trials (NCT01247324 and NCT01412333).
The data were presented at the 4th Congress of the European Academy of Neurology (EAN) that ran from June 16 to 19 in Lisbon. The study, “Effect of Ocrelizumab on Relapse Rate, and Disability Progression and Improvement in Relapsing Multiple Sclerosis Patients in the Open-Label Extension of the Pooled OPERA Trials” (abstract EPR1089), was sponsored by Hoffmann-La Roche, the global pharmaceutical company to which Genentech, the treatment’s developer, belongs.
OPERA I and OPERA II compared the safety and effectiveness of Ocrevus, an immune B-cell-depleting infusion therapy, with Rebif, a standard injection therapy, for 96 weeks. Now, in the ongoing extension phase of these trials (OLE period), researchers are evaluating the long-term impact both of continuous Ocrevus treatment and of switching from Rebif to Ocrevus.
To date, more than 89% of the RMS patients in the OLE extension study have completed two years of treatment there.
Patients who switched therapies had a reduction in relapse frequency of about 50% in the first year and 60% in the second year, the study reported, compared to annualized rates before the treatment change (0.20 in the year prior, and 0.10 and 0.08 at years one and two post-switch, respectively).
These data demonstrate that switching from Rebif to Ocrevus is “associated with a consistent and robust reduction in annualized relapse rates” that was maintained through the extension studies, the researchers noted.
Patients given Ocrevus in both the OPERA studies and their extensions continued to show low annualized relapse rates that were sustained over the following two years — 0.11 in year one and 0.08 in year two.
Compared to the patient group that switched treatments, a lesser proportion of those continuously treated with Ocrevus showed evidence of 24-week confirmed disability progression and a greater proportion had delayed disability, the presentation shows.
These results, moreover, were observed at all time points analyzed. Confirmed disability progression was 7.7% (Ocrevus continuous) vs. 12% (switchers) in the year before the OLE switch; 10.1% vs. 15.6%, respectively, at year one; and 13.8% vs. 18.1%, respectively, at year two. In terms of delayed disability, the findings were 16.8% (Ocrevus continuous) vs. 13.3% (switchers) in the pre-switch year; 20.6% vs. 16.6%, respectively, at year one; and 23.7% vs. 18.9%, respectively, at year two.
Collectively, these results further show that benefits seen in the OPERA trials were sustained through two additional treatment years in the studies’ open-label extensions, the researchers concluded.