The data was presented in a poster session Feb. 28, at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2019. The poster was titled “Real-World Experience with Ocrelizumab.”
Ocrevus, marketed by Genentech, was the first therapy approved by the U.S. Food and Drug Administration (FDA) to treat both relapsing multiple sclerosis and primary progressive multiple sclerosis (PPMS).
The effectiveness and safety of Ocrevus in relapsing MS and PPMS patients were demonstrated in three Phase 3 trials: two with relapsing MS patients — the OPERA I and OPERA II studies (NCT01247324 and NCT01412333), and one in PPMS patients, named ORATORIO (NCT01194570). Based on data from these trials, the FDA approved Ocrevus on March 28, 2017.
However, the research does not stop there. With Ocrevus’ approval, it is necessary to monitor and scrutinize its effectiveness, safety, and tolerability as it begins to be used in clinical practice around the United States.
“People in clinical trials are highly selected for, and so they may not represent the full spectrum of disease that you see in the clinic. So we just want to make sure that what you see in the clinic replicates the findings that you had in clinical trials,” Moss said.
Thus, the Cleveland Clinic researchers decided to assess how Ocrevus was performing at their center, compared to results from the previous three Phase 3 trials.
They ran a prospective longitudinal study — the examination of a group of subjects by assessing treatment outcomes over a period of time — for the tolerability, safety, and effectiveness of Ocrevus in patients treated at the Cleveland Clinic.
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