DrBen puts pen to paper and says ocrelizumab works for everybody with relapsing MS


Ocrelizumab efficacy in subgroups of patients with relapsing multiple sclerosis.Turner B, Cree BAC, Kappos L, Montalban X, Papeix C, Wolinsky JS, Buffels R, Fiore D, Garren H, Han J, Hauser SL.J Neurol. 2019 Feb 28. doi: 10.1007/s00415-019-09248-6. [Epub ahead of print]

OBJECTIVE: The efficacy and safety of ocrelizumab, versus interferon (IFN) β-1a, for the treatment of relapsing multiple sclerosis(RMS) from the identically designed OPERA I (NCT01247324) and OPERA II (NCT01412333) phase III studies has been reported; here we present subgroup analyses of efficacy endpoints from the pooled OPERA I and OPERA II populations.

METHODS:Patients with RMS were randomized to either ocrelizumab 600 mg administered by intravenous infusion every 24 weeks or subcutaneous IFN β-1a 44 µg three times per week throughout the 96-week treatment period. Relapse, disability, and MRI outcomes were analyzed for predefined and post hoc subgroups based on demographic and disease characteristics along with prior treatment using appropriate statistical tests to determine the treatment effect in subgroups and treatment-by-subgroup interactions

RESULTS:The significant treatment benefit of ocrelizumab, versus IFN β-1a, observed in the overall OPERA I and OPERA II pooled populations was maintained across most subgroup strata for all endpoints, including annualized relapse rate, disability progression, and MRI outputs.

CONCLUSIONS:The treatment effect of ocrelizumab versus IFN β-1a, measured by clinical and MRI outcomes, was maintained across most of the subgroups and strata of interest, and the pattern of treatment benefit across all subgroups was consistent with that from the pooled OPERA studies.

I didn’t know that DrBen could write…but he says that if you have relapsing MS, then this is the main thing that determines if you are going to respond to ocrelizumab.

There will of course be people with genetic variants that make this difficult

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  • We use ocelizumab as a second line treatment for RRMS, and can be first choice on primary and secondary progressive patients. How is your experience and preference for ocrelizumab, do you prefer as first line treatment for easy going relapsing remitting patients without progression?

  • Can you explain why they keep conparing to interferons? What is the number of people these days on interferons? Waste of time in my eyes. As i said where are the numbers?

    • Exactly my response Maria… it’s like comparing modern day IT to that from the 1950’s! What’s the point when it’s bound to provide evidence to favour the newer DMT.

    • Pharma likes trials that they know will be positive. They would go for comparison with placebo, if it wasn’t considered unethical now. That is why I don’t hold my breath for head-2-head studies between high efficacy DMTs.. at least not those that still have some patent live left 😉
      But we do need to be fair in assessing these trials and look at the dates when they started:
      OPERAI and OPERA II started in 2010 and 2011, but were probably designed at least one to two years earlier… that’s 10 years ago.

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