ClinicSpeak: headline ocrelizumab results

The eagle has landed: ocrelizumab headline results. #ECTRIMS2015 #MSBlog #MSResearch #ClinicSpeak

"These are the results we have all been waiting and will almost certainly be what ECTRIMS 2015 is remembered for."

Data from the Phase III studies in patients with relapsing MS showed:

  1. A 46-percent and 47-percent reduction in the ARR compared with interferon beta-1a over the two-year period in OPERA I and OPERA II, respectively (p<0.0001 and p<0.0001).
  2. A 43-percent and 37-percent risk reduction in CDP sustained for 12 weeks compared with interferon beta-1a in OPERA I and OPERA II, respectively (p=0.0139 and p=0.0169).
  3. A 43-percent and 37-percent risk reduction in CDP sustained for 24 weeks compared with interferon beta-1a in OPERA I and OPERA II, respectively (p=0.0278 and p=0.0370).
  4. A 94-percent and 95-percent reduction in the total number of T1 gadolinium-enhancing lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p<0.0001 and p<0.0001).
  5. A 77-percent and 83-percent reduction in the total number of new and/or enlarging hyperintense T2 lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p<0.0001 and p<0.0001).

The ORATORIO or PPMS study met its primary endpoint, showing treatment with ocrelizumab significantly reduced the risk of progression of clinical disability sustained for at least 12 weeks by 24 percent compared with placebo, as measured by the EDSS (p=0.0321). Additionally, ocrelizumab was superior to placebo in significantly reducing the risk of progression of clinical disability for at least 24 weeks by 25 percent (p=0.0365) and the time required to walk 25 feet (Timed 25-Foot Walk, or T25-FW) over 120 weeks by 29 percent (p=0.0404). Ocrelizumab decreased the volume of hyperintense T2 lesions by 3.4 percent over 120 weeks, compared to placebo which increased T2 volume by 7.4 percent (p<0.0001). Ocrelizumab reduced the rate of whole brain volume loss over
120 weeks by 17.5 percent compared to placebo (p=0.0206).



Ocrelizumab ECTRIMS Press Release from Gavin Giovannoni

CoI: multiple

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