Natalizumab (Tysabri) didn't slow disability progression in patients with secondary progressive multiple sclerosis (SPMS), researchers reported here.
The ASCEND trial missed its primary endpoint of reducing progression as measured by a composite endpoint assessing disability unrelated to relapses, Deborah Steiner, MD, of Biogen, reported during the emerging science session at the American Academy of Neurology meeting here.
But Steiner noted that there was a significant benefit on upper extremity function.
"There's a striking contrast between the lack of effect on ambulatory function as measured by the timed 25-foot walk test, and the effects on upper extremity function as measured by the 9-hole peg test," she said.
There are currently no approved therapies for primary progressive or secondary progressive MS -- although data reported here on ocrelizumab, an investigational B-cell targeting therapy by Roche/Genentech, suggested the drug has some efficacy in primary progressive disease.
A total of 887 patients randomized to placebo or 300 mg natalizumab infusion every 4 weeks for 96 weeks. Most of the patients had advanced disability at baseline, with 63% having an EDSS score in the range of 6.0 to 6.5, and scores on the 9HPT suggested more lower-limb impairment than upper-limb.
Overall, the trial did not meet its primary endpoint, although a slightly smaller proportion of patients on natalizumab were progressors than those on placebo (44% versus 48%), she reported.
The drug did, however, show a statistically significant treatment effect on reducing upper-limb disability progression unrelated to relapse as measured by the 9HPT, with fewer progressors (15% versus 23%, OR 0.56, P=0.0012).
Natalizumab was generally well tolerated, she added, with adverse events that were consistent with its known safety profile.
http://www.medpagetoday.com/MeetingCoverage/AAN/57482
The ASCEND trial missed its primary endpoint of reducing progression as measured by a composite endpoint assessing disability unrelated to relapses, Deborah Steiner, MD, of Biogen, reported during the emerging science session at the American Academy of Neurology meeting here.
But Steiner noted that there was a significant benefit on upper extremity function.
"There's a striking contrast between the lack of effect on ambulatory function as measured by the timed 25-foot walk test, and the effects on upper extremity function as measured by the 9-hole peg test," she said.
There are currently no approved therapies for primary progressive or secondary progressive MS -- although data reported here on ocrelizumab, an investigational B-cell targeting therapy by Roche/Genentech, suggested the drug has some efficacy in primary progressive disease.
A total of 887 patients randomized to placebo or 300 mg natalizumab infusion every 4 weeks for 96 weeks. Most of the patients had advanced disability at baseline, with 63% having an EDSS score in the range of 6.0 to 6.5, and scores on the 9HPT suggested more lower-limb impairment than upper-limb.
Overall, the trial did not meet its primary endpoint, although a slightly smaller proportion of patients on natalizumab were progressors than those on placebo (44% versus 48%), she reported.
The drug did, however, show a statistically significant treatment effect on reducing upper-limb disability progression unrelated to relapse as measured by the 9HPT, with fewer progressors (15% versus 23%, OR 0.56, P=0.0012).
Natalizumab was generally well tolerated, she added, with adverse events that were consistent with its known safety profile.
http://www.medpagetoday.com/MeetingCoverage/AAN/57482
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