#ACTRIMS2017 – No Evidence of Progression More Likely Among PPMS Patients on Ocrevus

#ACTRIMS2017 – No Evidence of Progression More Likely Among PPMS Patients on Ocrevus

Genentech’s Ocrevus (ocrelizumab) increased the proportion of patients with no evidence of progression (NEP) in the recently concluded ORATORIO Phase 3 clinical trial in patients with primary progressive multiple sclerosis (PPMS).

The evaluation of NEP — a combined measure of three disability assessments — was a secondary exploratory endpoint of the clinical trial. Researchers presented the results of their analysis today at ACTRIMS 2017 Forum, taking place Feb. 23-25 in Orlando, Florida.

The presentation, “Evaluation of no evidence of progression (NEP) in patients with primary progressive multiple sclerosis in the ORATORIO trial,” was part of the Poster Session 1 and Opening Networking Event on the meeting’s first day.

In the ORATORIO trial (NCT01194570), a total of 230 placebo and 461 Ocrevus-treated PPMS patients were evaluated every 12 weeks for up to 120 weeks. Participants received Ocrevus 600 mg or placebo every 24 weeks. During the study period, non-placebo patients received at least five 600 mg Ocrevus doses.

NEP was defined as having no disability progression as measured by the Expanded Disability Status Scale (EDSS) at 12 weeks, and no confirmed progression of 20 percent or more on the timed 25-foot walk test and on the 9-hole peg test. These tests cover the patient’s overall disability, including both arm function and ambulation. Patients continued evaluations until the end of the study or until researchers recorded a pre-specified number of progressions.

At 120 weeks, 42.7 percent of Ocrevus-treated patients reached NEP, compared to only 29.1 percent among those receiving placebo. The difference represents a 47 percent relative increase in the Ocrevus group.

Researchers also assessed the components of NEP in a pairwise manner. They found that more patients treated with Ocrevus did not experience progression on EDSS in combination with the 25-foot walk test (44.7 percent versus 31.3 percent in the placebo group).

Combining the 25-foot walk test and the 9-hole peg test also revealed a greater proportion in the Ocrevus group (48.4 percent) than in the placebo group (36.1 percent). The smallest change was seen when researchers analyzed EDSS and the 9-hole peg test together; for these parameters, there was only a 15 percent relative increase among Ocrevus-treated (61.4 percent) compared to those receiving placebo (53.5 percent).

The U.S. Food and Drug Administration (FDA) is currently reviewing the Biologics License Approval for Ocrevus in the United States and will likely make its verdict public March 28.

 

Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

4 comments

  1. Thomas W. Leatherbee says:

    This article was very interesting and enlightening, while at the same time, disturbing. My disease, leaves me very confused, unable to concentrate or sleep, very forgetful and thoughtless towards my wife. This is the woman, that has stood by me for 38+ years, without a complaint and I treat her terribly. I can’t seem to concentrate enough to put two thoughts together, remembering what I was even thinking about…I guess that I am in a little trouble, at the moment.
    If you people can help, I would really appreciate it.
    Thank You,
    Thomas W. Leatherbee
    Phone #- 1-(508)-441-7194
    E-Mail- [email protected]

    • Heidi says:

      How are you feeling Thomas? I pray your doing better. I have found myself becoming more irritable and less patient . Very sad. I was diagnosed with ms 20 yrs ago and am not looking forward to starting my new treatment. I always feel like a human Guinea pig

  2. Mark Hill says:

    Thanks for the article. Ocrevus.. don’t know why anyone, let alone any responsible health authority, would even consider this drug. It’s results are pathetic. Worse still, the long term effects of knocking out B cells may well result in cancer. Sadly, more wrongfully raised hopes in the PPMS community. Ocrevus, like all the powerful immune system suppressors of this type, will one day be viewed as a very expensive, box-headed blunder. It’s time the permeability of the bloodbrain barrier was fixed (which would end MS). Fortunately, there are some sensible researchers beginning to succeed in this area. But, the sooner the Ocrevus hype bubble is burst, the better; the results and prospects of this drug are so poor. It’s just drug industry hype which is grossly unfair on desperate patients.

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