08 Maj, 2019

Roche to present new OCREVUS (ocrelizumab) data analyses showing significant reduction of disability progression in relapsing and primary progressive multiple sclerosis at the AAN Annual Meeting

  • New analyses show the effect of OCREVUS on reducing the risk of disability progression is associated with exposure and lower B-cell levels
  • Long-term data in RMS and PPMS show that earlier treatment with OCREVUS significantly reduced the risk of permanent disability progression
  • Over 100,000 people have been treated with OCREVUS globally, in clinical trial and real-world settings; data presented at the AAN Annual Meeting highlights a consistent and favourable benefit-risk profile 

 

Basel, 8 May 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new OCREVUS® (ocrelizumab) data in relapsing and primary progressive multiple sclerosis (MS) were presented at the 71st American Academy of Neurology (AAN) Annual Meeting from 4-10 May in Philadelphia, Pennsylvania. New analyses on OCREVUS show its effect on reducing the risk of disability progression is associated with higher exposure to the medicine and lower B-cell levels, and show the positive impact of OCREVUS in significantly reducing disability progression.

With rapidly growing real-world experience and more than 100,000 patients treated globally, OCREVUS is the first and only therapy with six-month dosing approved for both relapsing MS (RMS), (including RRMS and active, or relapsing, secondary progressive MS) and primary progressive MS (PPMS). Additionally, new safety data presented at AAN representing 4,501 patients with RMS and PPMS and 12,559 patient years of exposure to OCREVUS, across all OCREVUS clinical trials, remain consistent with the medicine’s favourable benefit-risk profile.

“These are the first data to show that higher OCREVUS exposure is associated with greater control of disability progression without impacting safety,” said Stephen Hauser, MD, chair of the Scientific Steering Committee of the OPERA studies and director of the Weill Institute for Neurosciences at the University of California, San Francisco. “These analyses, along with long-term data that show OCREVUS reduced the risk of permanent disability progression, create a compelling case for initiating the therapy early in the disease course and provide important information that clinicians can use to inform treatment decisions.”


New data from pharmacokinetic, pharmacodynamic and exposure analyses – or how OCREVUS is processed in an individual’s body over time – show higher exposure to OCREVUS correlated with lower B-cell levels and lower rates of disability progression in patients. In patients with RMS, OCREVUS reduced the risk of 24-week confirmed disability progression (CDP) at all exposure levels compared with interferon beta-1a. There was lower risk of disability progression with higher exposure to OCREVUS.
 

A similar pattern was observed for patients with PPMS, in which OCREVUS reduced the risk of 24-week CDP at all exposure levels compared with placebo. OCREVUS reduced T1 gadolinium-enhancing and new/enlarging T2 MRI lesions to nearly undetectable levels in RMS and PPMS patients and reduced annualized relapse rates to low levels (0.13-0.18) in RMS patients across all exposure segments. Notably, safety findings remained consistent across all OCREVUS exposure levels, suggesting that higher exposure does not increase the likelihood of adverse events.

Long-term data, of over five years, from the Phase III OPERA and ORATORIO open-label extension (OLE) trials in RMS and PPMS, show that earlier treatment with OCREVUS significantly reduced the risk of permanent disability progression and this effect was sustained over time. In the OPERA OLE, the proportion of RMS patients with 48-week CDP was lower for those treated with continuous OCREVUS (total of five 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 three years on OCREVUS) (10.4% vs. 15.7%; p=0.004). In the ORATORIO OLE, the proportion of PPMS patients with 48-week CDP was lower in those treated with continuous OCREVUS over five and a half years compared with patients who switched to OCREVUS from placebo after the 120-week double-blind period (43.7% vs 53.1%; p=0.03).

Additionally, interim results of the Phase III Ocrelizumab Biomarker Outcome Evaluation (OBOE) study show that OCREVUS reduced the presence of a nerve cell damage and inflammation biomarker in serum and cerebrospinal fluid at 12, 24 and 52 weeks in patients with RMS. These one-year data add to the growing body of evidence to identify biomarkers of disease progression in MS and the benefit of OCREVUS on these markers. 

OCREVUS is now approved in 85 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union.

Full session details and data presentation listings for the 2019 AAN Annual Meeting can be found at the meeting website: https://www.aan.com/conferences-community/annual-meeting/.

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