Early initiation of and continuous treatment with ocrelizumab for up to 5 years was associated with a more sustained reduction of relapsing multiple sclerosis (RMS) progression compared with patients who switched to ocrelizumab after 2 years of interferon (IFN) β-1a therapy, according to study results published in Neurology.
Eligibility criteria for patients consisted of MS diagnosis, an age of 18 to 55 years, and screening Expanded Disability Status Scale (EDSS) score of 0 to 5.5. Patients with RMS who completed 2 years of treatment in the OPERA I and (Clinicaltrials.gov Identifier NCT01247324) and OPERA II (Clinicaltrials.gov Identifier NCT01412333) phase 3 trials continued to ocrelizumab infusions (600 mg every 24 weeks; n=623) or switched from IFN β-1a (44 μg 3 times per week) to ocrelizumab (n=551) as they entered an open-label extension phase. These patients completed a total of 5 years with treatment. Study outcomes included the adjusted annualized relapse rate, time to onset of 24-week confirmed disability progression/improvement, brain magnetic resonance imaging (MRI) activity (gadolinium-enhanced and new/enlarging T2 lesions), and percentage brain volume change.
The cumulative proportion of patients with a 24-week confirmed disability progression was significantly lower at year 5 among patients who started ocrelizumab earlier compared with those who initially received IFN β-1a (16.1% vs 21.3%, respectively; P =.014). Patients who continued ocrelizumab therapy maintained near complete and sustained suppression of new brain MRI lesion activity from years 3 to 5; those who switched to ocrelizumab from IFN β-1a attained this outcome within the same time frame. During the open-label extension phase, patients who continued ocrelizumab therapy had less whole brain volume loss from baseline during the double-blind study compared with patients who switched to ocrelizumab from IFN β-1a (-1.87% vs -2.15% at year 5; P <.01).
Limitations of this study included the lack of blinding during the open-label extension phase, consequent EDSS rater assessment bias, and the lack of a control group.
“These and other data support the early use of highly effective therapies that impact clinical and MRI measures of disease activity and progression in RMS to optimize short- and long-term patient outcomes,” the researchers concluded.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Hauser SL, Kappos L, Arnold DL, et al. Five-years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology. Published online July 20, 2020. doi: 10.1212/WNL.0000000000010376