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   DIR Return to: COPAXONE, GLATOPA (glatiramer acetate)
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       #Post#: 769--------------------------------------------------
       (AAN) Patient experience w/40mg Copaxone 3x/week--GLACIER
       extension study
   DIR By: agate
       Date: May 4, 2015, 3:59 pm
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       Presented at the recent annual AAN conference in Washington, DC:
       --- Quote ---
       > [P7.218] Patient experience with glatiramer acetate 40 mg/1 mL
       three-times weekly treatment for relapsing-remitting multiple
       sclerosis: Results from the GLACIER extension study
       >
       > Daniel Wynn,1Scott Kolodny,2Svetlana Rubinchick,3Joshua R.
       Steinerman,4Volker Knappertz,4,5Jerry Wolinsky,6on behalf of the
       GLACIER study group
       >
       > 1Northbrook, IL, USA, 2Cleveland, OH, USA, 3Netanya, Israel,
       4Frazer, PA, USA, 5Düsseldorf, Germany, 6Houston, TX, USA.
       >
       > OBJECTIVE:
       >
       > To evaluate patient-centric outcomes among individuals with
       relapsing-remitting multiple sclerosis (RRMS) treated with
       subcutaneous injections of glatiramer acetate 40 mg/mL
       three-times weekly (GA40) during the extension phase of the
       GLACIER study.
       >
       > BACKGROUND:
       >
       > The randomized, open-label GLACIER study evaluated safety,
       tolerability, and patient experience in RRMS patients converting
       to GA40 from glatiramer acetate 20 mg/mL once-daily (GA20). In
       the extension phase, GA20 completers were invited to convert to
       GA40, and GA40 completers continued on GA40.
       >
       > In the 4-month core study patients converting to GA40 had a
       50% lower rate of injection-related adverse events (IRAEs) than
       those randomized to continue GA20. Patient expectations that
       GA40 would be more convenient than GA20 were confirmed after
       conversion.
       >
       > METHODS:
       >
       > Patients converting from GA20 to GA40 for the extension phase
       (converters, n=97) and those continuing GA40 treatment
       (non-converters, n=101) were evaluated. Assessment of IRAEs was
       performed based on patient diary recordings of IRAE occurrence
       and severity. The Treatment Satisfaction Questionnaire for
       Medication-9 (TSQM-9) items 4-6 assessed patient-reported
       perceptions of convenience, with higher scores representing more
       positive perceptions.
       >
       > RESULTS:
       >
       > 99% of GA20 completers and 100% of GA40 completers consented
       to participate in the extension phase. Converters and
       non-converters had the same mean duration of drug exposure (126
       days) and similar annualized IRAE rates on GA40 during the
       extension phase (23.1 vs 28.0 events/year). During the core
       phase, the annualized IRAE rate for GA20 was 90.2 events/year.
       Converters demonstrated an improvement in mean convenience
       score, from 78.0 following GA20 treatment to 82.2 at last
       observation following conversion to GA40. Those continuing on
       GA40 maintained convenience scores of 85.1 at the beginning of
       the extension phase and 84.9 at last observation.
       >
       > CONCLUSIONS:
       >
       > The extension phase of the GLACIER study demonstrates that
       patients converting from GA20 to GA40 perceive a convenience
       benefit and report fewer IRAEs.
       >
       > __________________
       > Category - MS and CNS Inflammatory Disease: Clinical Science
       >
       > Session: P7: Poster Session VII: MS and CNS Inflammatory
       Diseases: Clinical Trials (2:00 PM-6:30 PM)
       > Date/Time: Thursday, April 23, 2015 - 2:00 pm
       >
       --- End Quote ---
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