30.09.2019

Pressemeddelelse: Roche presents new 6-year OCREVUS (ocrelizumab) data

Roche presents new 6-year OCREVUS (ocrelizumab) data which showed that earlier initiation and continuation of treatment reduced disability progression in multiple sclerosis

  • Post-hoc analysis from a Phase III open-label extension study showed a 42 percent reduction in the risk of PPMS patients needing a wheelchair after 6.5 years of OCREVUS treatment compared with patients who started OCREVUS after the double-blind period
  • Interim analysis of Phase IIIb study shows 87 percent of patients with suboptimal response to previous treatment had no evidence of disease activity one year after switching to OCREVUS
  • Separate analysis from same study showed greater patient satisfaction with OCREVUS after one year on treatment
  • More than 120,000 people have been treated with OCREVUS globally, in clinical trial and real-world settings; data continue to show a consistent and favourable benefit-risk profile

 

Basel, 13 September 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced longer-term data from the Phase III open-label extension studies of OPERA I, OPERA II and ORATORIO showed that patients who were treated with OCREVUS® (ocrelizumab) continuously for six years or more had reduced risk of disability progression in relapsing MS (RMS) and primary progressive MS (PPMS). These results suggest earlier treatment with OCREVUS reduced the risk of disability progression and this effect was sustained over time. Additionally, new safety data as of January 2019 were announced, representing 4,611 patients with RMS and PPMS and 14,329 patient years of exposure to OCREVUS, across all OCREVUS clinical trials, and remain consistent with the medicine’s favourable benefit-risk profile. Findings were presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm, Sweden.

“The effect of MS therapies on progression – not just relapses – is very important to help reduce the impact of the disease on the daily lives of people with MS and their families,” said Professor Gavin Giovannoni, Consultant Neurologist at Barts and the London School of Medicine and Dentistry. “The OCREVUS data at ECTRIMS highlight that the benefit of delaying, and possibly preventing, disability progression is greater when the treatment is used earlier in the disease course for both relapsing and primary progressive forms of MS. These data support the aphorism, ‘time really is brain and spinal cord in multiple sclerosis.'” 

In the OPERA OLE, the proportion of RMS patients with 24-week confirmed disability progression (CDP) 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) (19 percent vs. 24 percent; p<0.05).

In the ORATORIO OLE, the proportion of PPMS patients with 24-week CDP 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 (52 percent vs. 65 percent; p=0.002). Upper limb disability progression, measured by the nine-hole peg test (9-HPT), was significantly reduced in patients who were continuously treated with OCREVUS compared with those who switched from placebo (31 percent vs. 43 percent; p=0.004). Data also showed earlier intervention with OCREVUS resulted in a 42 percent reduction in the risk of PPMS patients needing a wheelchair (EDSS≥7) over 6.5 years compared with patients who started OCREVUS treatment after the double-blind period (p=0.0112).

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

A new, separate analysis from the same study showed that patients who switched from another DMT to OCREVUS reported greater satisfaction with OCREVUS after one year of treatment. Patients reported satisfaction with its effectiveness, side effects, convenience and overall satisfaction, as measured by the self‐reported Treatment Satisfaction Questionnaire for Medication vII (TSQM vII).

Furthermore, results from two Phase IIIb studies, the CHORDS substudy in RRMS and the SaROD study in PPMS and RMS, 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.

OCREVUS is the first and only therapy approved for both RMS (including relapsing-remitting MS (RRMS) and active, or relapsing, secondary progressive MS, in addition to clinically isolated syndrome in the U.S.) and PPMS. OCREVUS is dosed every six months, with rapidly increasing real-world experience and more than 120,000 people with MS treated globally. OCREVUS is now approved in 89 countries across North America, South America, the Middle East, and Eastern Europe, as well as in Australia, Switzerland and the European Union.

Full session details and data presentation listings for ECTRIMS can be found at the congress website: https://www.ectrims-congress.eu/2019.html

Follow Roche on Twitter via @Roche and keep up to date with ECTRIMS news and updates by using the hashtag #ECTRIMS2019.

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