Ocrevus (ocrelizumab), an investigational monoclonal antibody, significantly decreases disease activity in patients with multiple sclerosis (MS), and is associated with a higher proportion of patients reaching no evidence of disease activity (NEDA), according to a new analysis.
The study, “NEDA analysis by epoch in patients with relapsing multiple sclerosis treated with ocrelizumab: results from the OPERA I and OPERA II phase III studies,” was recently presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2017 Forum, Feb. 23-25 in Orlando, Florida.
NEDA is a parameter that measures the absence of disease activity (in clinical settings and in magnetic resonance imaging) in MS patients. This parameter is increasingly recognized for its utility in clinical trials and is a potential goal for MS therapeutics.
Ocrevus is a humanized antibody previously tested in two clinical trials, the OPERA I (NCT01247324) and OPERA II (NCT01412333), and showed promising and robust results in halting MRI disease activity in patients with relapsing MS. The OPERA studies investigated the effect of Ocrevus vs. Rebif (interferon beta 1-a), a standard therapy for relapsing MS.
Researchers re-analyzed the results of the OPERA studies to assess the effect of Ocrevus on NEDA.
The team found that a higher proportion of patients treated with Ocrevus achieved NEDA during weeks 0 to 24, when compared to patients receiving Rebif in the same period. The positive effects of Ocrevus continued after week 24, with patients exhibiting NEDA during weeks 24 to 96. This, researchers found, represented a 72% increase in NEDA relative to patients treated with Rebif.
Patients who still exhibited early evidence of disease activity in weeks 0–24 or weeks 0-48, and were treated with Ocrevus eventually also reached NEDA in weeks 24–96 or weeks 48–96, respectively. NEDA was always detected in higher proportions in patients treated with Ocrevus relative to those receiving Rebif. Specifically, a 177% and 81% increase in NEDA relative to Rebif at weeks 24–96 and weeks 48–96, respectively.
Overall, “ocrelizumab [Ocrevus] consistently resulted in a profound reduction of clinical and subclinical disease activity versus Rebif, as measured by NEDA across various epochs,” researchers concluded. “In contrast with IFNβ-1a, the majority of patients who had evidence of disease activity early in the study subsequently achieved NEDA with ocrelizumab.”
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