DX64
Confirmed Disability Improvement in Patients with Relapsing Multiple Sclerosis in the Open-Label Extension Period of the Pooled Opera Trials
The efficacy and safety of ocrelizumab (OCR) in relapsing multiple sclerosis (RMS) were demonstrated in the 96-week double-blind control period of OPERA I and II (NCT01247324; NCT01412333). Upon completion of the controlled treatment period, all patients were eligible to enter an OCR open-label extension (OLE) phase.
Objectives:
To assess the efficacy of switching to or maintaining OCR therapy on the proportion of patients experiencing disability improvement in the OLE period of Phase III trials in RMS.
Methods:
During the controlled treatment period, patients received intravenous OCR 600 mg every 24 weeks or subcutaneous interferon beta-1a (IFN β-1a) 44 μg three times weekly for 96 weeks. At the start of the OLE period, patients continued (OCR-OCR) or were switched from IFN β-1a to OCR (IFN-OCR). Compared with baseline, disability improvement was defined as a reduction in Expanded Disability Status Scale (EDSS) score ≥1.0 point (baseline EDSS score of ≥2.0 and ≤5.5) or ≥0.5 points (baseline EDSS score of >5.5). Time to onset of 24-week confirmed disability improvement (CDI) was analyzed in patients with a baseline EDSS score of ≥2.0.
Results:
More than 89% of patients who entered the OLE period completed OLE Year 2. OCR-OCR continuers versus IFN-OCR switchers had higher proportions of patients with 24-week CDI in the year pre-switch (OCR-OCR n=454, 16.8%; IFN-OCR n=419, 13.3%; p=0.099), and Year 1 (OCR-OCR n=399, 20.6%; IFN-OCR n=366, 16.6%; p=0.089) and Year 2 (OCR-OCR n=363, 23.7%; IFN-OCR n=339, 18.9%; p=0.057) of the OLE period.
Conclusions:
The benefits of ocrelizumab on 24-week CDI as seen in the 2-year double-blind controlled period were maintained after 2 years in the OLE period.