Abstract

Objective: To evaluate patient-centric outcomes among individuals with relapsing-remitting multiple sclerosis (RRMS) treated with subcutaneous injections of Copaxone 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 Copaxone 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[percnt] 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:
[percnt] of GA20 completers and 100[percnt] 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.

Labels: Study