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Ocrelizumab Considered To Be a “Game Changer” in MS
A group of specialists contacted by MedPage Today are calling the experimental therapy ocrelizumab a “game changer” in the field of multiple sclerosis (MS) in 2015.
Although ocrelizumab, a second-generation monoclonal antibody targeting B-cells, is not yet approved for marketing, results of phase III trials reported in 2015 were impressive enough that those specialists picked it as the year's number-one advance in MS, MedPage Today reports.
The choice came from responses by 55 neurologists asked to pick the "game-changer" in their respective subspecialties. Here are their top selections by subspecialty:
- MS: Ocrelizumab results in ORATORIO and OPERA I and II
- Stroke: Publication of five trials confirming the efficacy of neurothrombectomy for acute ischemic stroke
- Parkinson's disease: New formulations delivering carbidopa/levodopa
- Sleep: SERVE-HF trial showing adaptive servoventilation increased mortality
- Alzheimer's disease: No clinical advance stood out, as new research during the year emphasized laying of groundwork for future trials
Three trials of ocrelizumab were presented in Barcelona at ECTRIMS in October. The OPERA I and II studies in relapsing-remitting MS (RRMS) found the anti-CD20 drug produced about a 50% reduction in annualized relapse rates compared with those taking interferon-beta 1a (Rebif) (P < 0.0001 for both studies). In ORATORIO the agent reduced the proportion of primary progressive MS (PPMS) patients who had 12-week confirmed disability progression by 24% compared with placebo (P = 0.0321).
While some experts in Barcelona suggested that the ORATORIO data in PPMS was less impressive than the OPERA results in RRMS, experts who responded to MedPage Today highlighted the importance of both trials.
Referring to the ORATORIO results, Dennis Bourdette, MD , chair of neurology at OHSU Healthcare in Portland, Oregon, said, "This is the first drug to be shown to be effective in this form of MS despite previous trials of other agents." Bruce A. Cohen, MD, of Northwestern University's Feinberg School of Medicine in Chicago, added that the results "are addressing to some degree our most pressing clinical need of effective treatment for progressive MS.".
OPERA 1 and 2 in RRMS "revealed outstanding efficacy and safety, with infrequent use that will be very attractive to patients. And it trounced one of the standard interferon therapies," according to John R. Corboy, MD, co-director of the Rocky Mountain MS Center, Anschutz Medical Campus, University of Colorado Denver. Corboy added that he hoped the results "will finally push more practitioners to utilize highly efficacious therapy as soon as people are diagnosed, as the natural history data suggests we should be doing already."
Several experts said they expect rapid approval of ocrelizumab as a first-line agent.
Source: MedPage Today, December 23, 2015.