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       #Post#: 312--------------------------------------------------
       Study involving 24-week interruption of Tysabri
       By: agate Date: May 13, 2014, 2:23 pm
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       From the MS International Federation newsletter, MS Research
       News, May 13, 2014:
       [quote]The RESTORE trial: What did we learn about multiple
       sclerosis?
       RESTORE was a randomized, partially placebo-controlled
       exploratory study evaluating multiple sclerosis (MS) disease
       activity during a 24-week interruption of natalizumab.
       The objectives of RESTORE were to explore the course of MS
       disease activity and the effects on pharmacokinetic,
       pharmacodynamic, and immune parameters in patients undergoing an
       interruption of natalizumab therapy for up to 24 weeks as
       compared with those in patients remaining on natalizumab. It
       also assessed the effects of alternate therapies during
       natalizumab interruption and after restarting natalizumab.
       Patients with MS receiving natalizumab were randomized into
       three treatment arms in a 1:1:2 ratio:
       natalizumab:placebo:alternate immunomodulatory therapy
       (interferon b-1a, glatiramer acetate or methylprednisolone).
       A total of 175 patients were enrolled. At the baseline visit,
       all patients received a standard 300-mg natalizumab infusion.
       Starting at week 4, patients randomized to natalizumab or
       placebo received infusions every four weeks through to week 24
       in a double-blind fashion. Patients randomized to other
       therapies who chose interferon b-1-a (IM IFN-b-1a) or glatiramer
       acetate (GA) received their first injections on day 0. Patients
       randomized to other therapies who chose methylprednisolone (MP)
       received infusions every four weeks starting at week 12.
       Clinical, MRI, and laboratory evaluations were performed every
       four weeks during the randomized treatment period starting at
       week 0, at the time of suspected relapse, and at the final
       visit. At week 28, patients resumed open-label infusions of
       natalizumab and stopped placebo or other therapy. Participants
       were followed for an additional 24 weeks, concluding the study
       at week 52.
       Disease recurred in a large proportion of RESTORE patients who
       discontinued natalizumab treatment. The safety evaluations were
       generally consistent with the labeled risk profile for each of
       the respective marketed products, notably for natalizumab.
       Natalizumab treatment interruption resulted in occurrence of MRI
       disease activity as early as 12 weeks, and of clinical disease
       activity as early as 4–8 weeks, after the last natalizumab dose.
       Relapses occurring during the first one to three months have
       also been observed. In RESTORE, GA starting after the last dose
       of natalizumab and monthly MP starting 12 weeks after the last
       natalizumab dose did not appear to be effective in disease
       suppression, as compared with continued natalizumab treatment.
       Authors: Karceski S.
       Source: Neurology. 2014 Apr 29;82(17):e155-7. doi:
       10.1212/WNL.0000000000000423.[/quote]
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