Article Text
Abstract
Background No Evidence of Disease Activity (NEDA) measures the absence of detectable clinical and magnetic resonance imaging (MRI) disease activity in relapsing multiple sclerosis. NEDA analyses using re-baselining may better reflect the effects of disease-modifying treatments.
Objective To assess the effect of ocrelizumab on NEDA by epoch in the pooled OPERA I/II (NCT01247324/NCT01412333) studies.
Methods Patients received ocrelizumab 600 mg every 24 weeks or subcutaneous interferon beta-1a (IFNβ−1a) 44 µg three-times weekly for 96 weeks. Brain MRI was undertaken at baseline and Weeks 24, 48, and 96. NEDA (i.e., the absence of protocol-defined relapses, 12 week confirmed disability progression, new/enlarging T2 lesions and T1 gadolinium-enhancing lesions) was assessed from baseline-Week 96, baseline-Week 48, Week 48 Week 96, baseline-Week 24 and Week 24 Week 96.
Results Over 96 weeks, ocrelizumab was associated with a 75% increase in the proportion of patients with NEDA versus IFNβ−1a (p<0.0001). Compared with IFNβ−1a, ocrelizumab increased the proportion of patients with NEDA from baseline-Week 48 (56%), Week 48 Week 96 (43%), baseline-Week 24 (33%) and Week 24 Week 96 (72%; all epochs p<0.0001).
Conclusions A higher proportion of patients reached NEDA at first MRI (Week 24) with ocrelizumab versus IFNβ−1a; after re-baselining from Week 24–96, the proportion reaching NEDA increased further.