Once‐daily glatiramer acetate decreases magnetic resonance imaging disease activity in Japanese patients with relapsing–remitting multiple sclerosis

Abstract

ObjectiveMultiple sclerosis (MS) prevalence, clinical patterns, and treatment responses vary between races and geographical latitudes. Glatiramer acetate (GA; Copaxone) has provided a safe, effective treatment option for relapsing–remitting MS patients in the USA, European nations, and other countries for decades. The objective of the present study was to assess the safety and efficacy of GA in reducing magnetic resonance imaging disease activity in Japanese patients with active relapsing–remitting MS.MethodsThis phase 2, multicenter, open‐label, single‐arm, 52‐week study measured the effect of GA 20 mg once‐daily on magnetic resonance imaging disease activity. GA efficacy was evaluated through week 36, and safety through week 52. The primary end‐point was change in the mean number of T1‐weighted gadolinium‐enhancing (GdE) lesions from pretreatment (weeks –8, –4 and baseline) to weeks 28, 32 and 36. Secondary end‐points included a change in mean number of new T2‐weighted lesions, GdE lesion and T2 lesion volumes, annualized relapse rate, and Expanded Disability Status Scale scores.ResultsGA therapy reduced the number of new GdE lesions by 65.66% (95% CI 33.19–82.35%). The number of new T2 lesions and GdE lesion volume were also reduced from pretreatment. The annualized relapse rate was reduced by 42% compared with the 1 year before treatment. Changes in T2 lesion volume and Expanded Disability Status Scale scores were favorable, but less pronounced. Most common adverse events were injection‐site reactions.ConclusionsThe present study confirmed the well‐established safety, tolerability and efficacy profile of GA in Japanese MS patients.

Long‐term, single‐arm, open‐label, multicenter phase 2/4 study of glatiramer acetate by subcutaneous injection in Japanese patients with relapsing–remitting multiple sclerosis

“…Patients had a disease duration of 84.8 months (SD 83.7 months), with an average of 2.0 (SD 2.2) relapses in the previous year. The mean EDSS was 2.5 (SD 1.2) …”

“…Key inclusion and exclusion criteria for the present study have previously been described . In brief, eligible patients were Japanese and had confirmed RRMS as per the Revised McDonald Criteria (2005); at least one MS recurrence in the previous year, but no relapse in the 30 days before screening; 1–15 GdE lesions on any three screening magnetic resonance imaging (MRI) scans; and Expanded Disability Status Scale (EDSS) of 0–5.0.…”

“…GdE and T2 lesions were evaluated using MRI scans, which were sent electronically to an MRI reading center for blinded, unbiased interpretation of the results. All assessments were carried out during screening to obtain baseline values, then at regular intervals up to week 52 . During the extension section after week 52, MRI assessments were undertaken at week 104, whereas EDSS scores were evaluated at week 78 and week 104, then every 26 weeks until study completion or study drug discontinuation.…”

“…Recently, we reported the results of a phase 2 study of GA 20 mg/mL QD in 17 Japanese patients with RRMS . In that study, GA was shown to significantly reduce the total number of T1 gadolinium‐enhancing (GdE) lesions from an adjusted mean of 5.66 lesions pre‐treatment to an adjusted mean of 1.94 during 36 weeks of treatment, a 65.66% reduction .…”

“…In that study, GA was shown to significantly reduce the total number of T1 gadolinium‐enhancing (GdE) lesions from an adjusted mean of 5.66 lesions pre‐treatment to an adjusted mean of 1.94 during 36 weeks of treatment, a 65.66% reduction . In addition, the point estimate of the total number of new T2 lesions decreased from an adjusted pre‐treatment mean of 3.28 to 1.49 post‐treatment . GA also showed an acceptable safety profile, with adverse events (AE) that were exclusively mild‐to‐moderate in severity in this patient population.…”