Ocrelizumab Data Underlines Clinical Benefit in Relapsing, Primary Progressive MS


New data provides insight into the safety and efficacy of the FDA-approved multiple sclerosis drug.

Data from 4 studies of ocrelizumab (Ocrevus) presented at the American Academy of Neurology annual meeting further support ocrelizumab as a treatment option for patients with relapsing or primary progressive forms of multiple sclerosis (MS).

The presentations will highlight new safety and efficacy data from the phase 2 and 3 trials of ocrelizumab, according to a press release.

In a pooled exploratory analysis of the phase 3 OPERA I and OPERA II studies, patients with relapsing MS administered ocrelizumab experienced a 55% reduction in relapse rate within the first 8 weeks of treatment compared with interferon beta-1a (Rebif).

A separate phase 2 study in patients with relapsing-remitting MS (RRMS) found that ocrelizumab demonstrated rapid and near-complete suppression of brain MRI activity at 8 weeks. This included T1 gadolinium-enhancing legions and hyperintense T2 lesions compared with placebo.

Regarding the efficacy of ocrelizumab, additional analyses of the phase 2 OPERA 1 and OPERA II showed that the ocrelizumab suppressed more than 90% of active MRI lesions over 2 years compared with interferon beta-1a in patients with early RRMS.

Additionally, ocrelizumab increased the proportion of patients who achieved No Evidence of Diseases Activity (NEDA) by 76% compared with interferon beta-1a over 2 years. The data were consistent with results in the overall ocrelizumab treated population.

“The rapid effect seen with Ocrevus in clinical trials provides insight into how this newly FDA-approved therapy could change the way MS is treated,” Stephen Hauser, MD, chair of the Scientific Steering Committee of the OPERA studies, said in the release. “Following the FDA approval of Ocrevus for relapsing or primary progressive forms of MS, it is encouraging to see the medicine’s favorable benefit-risk profile continue to play out in the data.”

A pooled data analysis for the phase 3 RRMS open-label extension studies found that patients who switched from interferon beta-1a to ocrelizumab experienced reductions in relapse rates and MRI brain lesions. Patients treated with ocrelizumab at the beginning of the study had a sustained benefit after 3 years.

Patients with PPMS with confirmed disability progression had a greater increase in fatigue in the ORATORIO study, which highlights the importance of preventing disease progression in patients with this form of MS. Patients who did not experience disability progression experienced a significant reduction in fatigue with ocrelizumab compared with the placebo.

In open-label extension studies that included more than 2200 patients with RRMS and PPMS, the investigators found that the safety of ocrelizumab was consistent with controlled treatment periods, according to the release.

The most common treatment-induced adverse events in all the phase 3 studies were infusion site reactions and upper respiratory tract infections.

Ocrelizumab is a humanized monoclonal antibody designed to target CD20-positive B cells. It is administered by intravenous infusion every 6 months, with the initial dose administered as two 300-mg infusions 2 weeks apart. Subsequent doses are administered as single 600-mg infusions.

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