Data: Ocrevus treatment reduced MS disability progression

September 18, 2019
Longer-term data from the Phase III studies of OPERA I, OPERA II and ORATORIO showed patients treated with Ocrevus® (ocrelizumab) continuously for six years or more had reduced risk of disability progression in relapsing MS and primary progressive MS. Results suggest earlier treatment with Ocrevus reduced the risk of disability progression and this effect was sustained over time. Additionally, new safety data remain consistent with the medicine’s favorable benefit-risk profile. 

In the OPERA open-label extension, the proportion of relapsing patients with 24-week confirmed disability progression was lower for those treated with continuous Ocrevus (total of six years on Ocrevus) compared with patients who switched to Ocrevus after two years of interferon beta-1a treatment in the double-blind period (total of four years on Ocrevus).

In the ORATORIO open-label extension, the proportion of progressive patients with 24-week confirmed disability progression was lower for those treated with continuous Ocrevus over six-and-a-half years compared with patients who switched to Ocrevus from placebo after the double-blind period. Upper limb disability progression was significantly reduced in patients who were continuously treated with Ocrevus compared with those who switched from placebo. Data also showed earlier intervention with Ocrevus resulted in a 42 percent reduction in the risk of progressive patients needing a wheelchair over 6.5 years compared with patients who started Ocrevus treatment after the double-blind period.

Additionally, data from the open-label Phase IIIb CASTING study evaluating Ocrevus in patients with relapsing MS who had a suboptimal response to at least six months of treatment with one or two other disease-modifying treatments were presented. An interim analysis showed 87 percent of patients who switched to Ocrevus had no evidence of disease activity after 48 weeks of treatment.

Furthermore, results from two Phase IIIb studies, the CHORDS substudy in relapsing MS and the SaROD study in progressive and relapsing MS, demonstrate patients treated with Ocrevus at a reduced infusion time showed no increased risk of serious, severe or life-threatening infusion-related reactions. The current infusion time is approximately 3.5 hours and a majority of the patients in these studies completed infusions within 2.5 hours. Frequency of administration is highly important to patients and their healthcare providers and potentially shorter Ocrevus infusion times once every six months may improve the overall treatment experience.

In addition to consistent overall safety outcomes, new data on 267 pregnancies in MS patients from Ocrevus clinical trials and real-world use were also in line with previous reports, and the reviewed cases to date do not suggest an increased risk of adverse pregnancy outcomes in case of accidental exposure within a year of conception or during pregnancy.

Findings were presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Stockholm.

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