Annual relapse rates plummet in patients with multiple sclerosis during extension study.
Preliminary results from an extension study demonstrated that ocrelizumab (Ocrevus) continued to decrease annual relapse rates in patients with relapsing and primary progressive multiple sclerosis (MS), according to Multiple Sclerosis News Today.
Ocrelizumab is a humanized anti-CD20 monoclonal antibody designed to slow the progression of MS. It was granted FDA approval in March 2017 to treat these 2 forms of MS, according to Multiple Sclerosis News Today.
The preliminary findings were presented at the Annual Meeting of the Consortium of Multiple Sclerosis Centers in New Orleans, and covered 96 weeks of the 144-week extension study.
In the Phase 3 OPERA I and OPERA II clinical trials, ocrelizumab slowed progression of MS, according to Multiple Sclerosis News Today. Of these study participants, many opted to take part in the OLE extension trial.
The primary objective of the OPERA studies was to determine whether ocrelizumab could lower the annual relapse rate in relapsing MS patients. The participants received either 600 mg of ocrelizumab intravenously every 24 weeks of 44 μg of injection interferon beta-1a (Rebif) 3 times per week for 96 weeks, the report noted.
For the extension study, both researchers and participants were aware of who received ocrelizumab. The primary objective will be the annual relapse rate at 144 weeks among patients with relapsing MS who received ocrelizumab or interferon beta-1a in the OPERA trials, followed by ocrelizumab in the OLE trial, according to Multiple Sclerosis News Today.
At 96 weeks, the preliminary results showed that patients who switched from interferon beta-1a to ocrelizumab had a lower annual relapse rate.
Relapse rates dropped from 0.245 relapses per year among OPERA I participants who received interferon beta-1a to 0.092 per year in the extension study. The rate among OPERA II participants who received interferon beta-1a fell from 0.254 to 0.115, according to Multiple Sclerosis News Today.
In both the OPERA and extension trials, patients who received ocrelizumab experienced lower annual relapse rates. The rate dropped from 0.136 in the OPERA I trial to 0.118 in the extension trial, and from 0.138 in the OPERA II trial to 0.100 in the extension study according to Multiple Sclerosis News Today.
“Patients who originally received ocrelizumab in the OPERA studies continued to have favorable unadjusted annualized relapse rate outcomes in the OLE,” the authors wrote, as reported by Multiple Sclerosis News Today. “Patients who switched from interferon beta-1a to ocrelizumab in the OLE rapidly experienced unadjusted annualized relapse rate outcomes consistent with those of patients who received continuous ocrelizumab.”