Author Topic: Ozanimod from Celgene may be added to the MS drugs  (Read 161 times)

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Offline agate

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From MedPage Today, April 27, 2017:

Ozanimod Keeps on Working in MS Extension Trial

Placebo patients switched to the investigative agent catch up in lowering relapse rate

by Florenz Turkel
Contributing Writer, MedPage Today

When patients diagnosed with multiple sclerosis are switched from placebo in clinical trials to the investigative agent ozanimod, the annualized relapse rate falls to levels similar to those achieved by patients who have been on the new drug throughout the trial, researchers reported.

In the core RADIANCE (part 1) trial, patients assigned to placebo experienced a 0.57 rate of relapses in the first 24 weeks, but once they were switched to ozanimod that rate fell to 0.31 on the 0.5 mg dose of ozanimod and to a rate of 0.27 if they were treated with the 1 mg dose of ozanimod, reported Jeffrey Cohen, MD, director of experimental neurotherapeutics at the Mellon Center for MS Treatment and Research at the Cleveland Clinic in Ohio.

That compared with a rate of 0.25 for patients who were originally assigned to ozanimod 0.5 mg at the start of the study and to a rate of 0.15 relapses a year among the patients who were started on ozanimod 1 mg at the beginning of the trial. The original trial and its extension are double-blinded.

After 2 years on the drug, there were little differences in relapse rates among those who started on ozanimod 0.5 mg and the original placebo patients switched to the lower dose a rate of 0.35 for the patients switched to ozanimod and a rate of 0.38 for those who had been on ozanimod for the 24-week treatment part of the trial, Cohen reported at the annual meeting of the American Academy of Neurology.

The story was the same for patients treated with 1 mg of ozanimod those who were switched from placebo had an annualized relapse rate of 0.12 compared with an annualized relapse rate of 0.15 for the patients who were on ozanimod from the get-go at the 2 year milestone.

"Both ozanimod 0.5 mg and 1 mg demonstrated continued efficacy on MRI and clinical measurements of multiple sclerosis disease activity over 2.5 years," Cohen said in his oral platform presentation.

The researchers included 82 patients in the extension trial who were originally on placebo. They were assigned to either the 0.5 mg or the 1 mg dose of ozanimod 41 patients in each group. They joined 84 patients who had been on ozanimod 0.5 mg at baseline and 81 patients who had been on ozanimod 1 mg from the start of the RADIANCE study.

Cohen said that the extension trial did not come with any surprises in the context of adverse events. "No new treatment-emergent adverse events associated with ozanimod over the 2 years or more treatment were observed," Cohen said. He said there were no new adverse effects seen by dose of the agent.

He did note that 5 patients who were found to have increased liver enzymes 5 times the upper limits of normal were taken off the drug. Ozanimod is a sphingosine-1-phosphate (S1P) receptor agonist. Phase III trials, including RADIANCE (part 2) are underway, Cohen said at the annual meeting of the American Academy of Neurology. Ozanimod specifically targets two of the five S1P sites, making it more selective that fingolimod (Gilenya).

The patients in the study were about 38 years old and 70% were women; more than 98% were white. They had been diagnosed with multiple sclerosis for about 3.8 years. The average number of relapses per year at baseline was 2. About 25% of the patients had previously been on prior medication for multiple sclerosis.

After a 30-day screening protocol, patients were given a 7-day period to escalate the oral dose to either 0.5 mg or 1 mg or placebo, and then took their assigned pills for 24 weeks. After that period, the patients on placebo were reassigned to either dose of the drug.

"The key as to where ozanimod will fit into clinical practice will depend on the safety profile," said Jennifer Graves, MD, assistant professor of neurology and ophthalmology at the University of California, San Francisco.

"The efficacy looks similar to other drugs in the field. So if there are fewer adverse events that could determine how the drug will fit in the marketplace," Graves, co-moderator of the session, told MedPage Today.

The trial was supported by Receptos, a subsidiary of Celgene, Inc.

Cohen disclosed relevant relationships with Merck, Novartis, and Receptos.

Graves disclosed relevant relationships with Genentech, Biogen, and S3 Group.
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SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.


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