Five-years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension

Objective To assess over 3 years of follow-up, the effects of maintaining
or switching to ocrelizumab (OCR) therapy on clinical and MRI outcomes and
safety measures in the open-label extension (OLE) phase of the pooled
OPERA studies in relapsing multiple sclerosis. Methods After 2 years of
double-blind, controlled treatment, patients continued OCR (600 mg
infusions every 24 weeks) or switched from interferon (IFN) β-1a (44 μg 3
times weekly) to OCR when entering the OLE phase (3 years). Adjusted
annualized relapse rate, time to onset of 24-week confirmed disability
progression/improvement (CDP/CDI), brain MRI activity (gadolinium-enhanced
and new/enlarging T2 lesions), and percentage brain volume change were
analyzed. Results Of patients entering the OLE phase, 88.6% completed Year
5. The cumulative proportion with 24-week CDP was lower in patients who
initiated OCR earlier, vs patients initially receiving IFN β-1a (16.1% vs
21.3% at Year 5; p=0.014). Patients continuing OCR maintained, and those
switching from IFN β-1a to OCR attained near complete and sustained
suppression of new brain MRI lesion activity from Year 3 to 5. Over the
OLE phase, patients continuing OCR exhibited less whole brain volume loss
from double-blind study baseline vs those switching from IFN β-1a (–1.87%
vs –2.15% at Year 5; p<0.01). Adverse events were consistent with
past reports and no new safety signals emerged with prolonged treatment.
Conclusion Compared with patients switching from IFN β-1a, earlier and
continuous OCR treatment up to 5 years provided sustained benefit on
clinical and MRI measures of disease progression.