DIR Return Create A Forum - Home
       ---------------------------------------------------------
       MS Speaks
  HTML https://msspeaks.createaforum.com
       ---------------------------------------------------------
       *****************************************************
   DIR Return to: TYSABRI (natalizumab)
       *****************************************************
       #Post#: 1186--------------------------------------------------
       Tysabri not helpful in reducing SPMS disability progression but 
       may benefit upper limb function
       By: agate Date: April 22, 2016, 9:14 pm
       ---------------------------------------------------------
       From MedPage Today, April 22, 2016:
       [quote]Tysabri No Help in SPMS
       Drug didn't reduce disability progression but may benefit upper
       limb function
       by Kristina Fiore
       Associate Editor, MedPage Today
       VANCOUVER -- 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.
       Still, there is little to offer patients with secondary
       progressive disease, Steiner said. Natalizumab is highly
       effective in relapsing MS, although it carries a higher risk of
       progressive multifocal leukoencephalopathy (PML) than many of
       the other relapsing MS therapies.
       To assess whether it may be able to slow disability progression
       unrelated to relapses in secondary progressive MS, the
       researchers conducted the ASCEND trial in patients who'd had
       SPMS for at least 2 years and who had disability progression
       unrelated to relapses in the prior year. None of them had been
       previously treated with natalizumab.
       The primary endpoint was a binary outcome of confirmed
       disability progressors or non-progressors on a composite
       endpoint of Expanded Disability Status Scale (EDSS), Timed
       25-Foot Walk Test (T25FW), and 9-Hole Peg Test (9HPT). This
       endpoint was designed to capture the treatment effects on key
       aspects of disability progression in SPMS, Steiner said.
       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.
       Steiner concluded that while natalizumab didn't delay the
       progression of ambulatory disability in SPMS, it was associated
       with significant slowing of upper-extremity disability
       progression and reduction of relapses and MRI activity.
       "The majority of patients had advanced disability, representing
       a global SPMS population for whom there is currently no
       effective therapy able to treat disability progression unrelated
       to relapses," she said.
       She added that the lack of treatment effects on ambulatory
       function underscores the importance of treating MS early with
       effective therapies like natalizumab.
       _______
       Steiner disclosed no financial relationships with industry.
       Co-authors reported financial relationships with several MS
       drugmakers.[/quote]
       *****************************************************