A 2-year observational study of patients with relapsing-remitting multiple sclerosis converting to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial

Abstract

Studies suggest that patients with relapsing-remitting multiple sclerosis (RRMS) who do not benefit from other disease-modifying treatments (DMTs) may benefit from converting to glatiramer acetate (GA). COPTIMIZE was a 24-month observational study designed to assess the disease course of patients converting to GA 20 mg daily from another DMT. Eligible patients had converted to GA and had received prior DMT for 3–6 months, depending on the reasons for conversion. Patients were assessed at baseline and at 6, 12, 18, and 24 months. In total, 672 patients from 148 centers worldwide were included in the analysis. Change of therapy to GA was prompted primarily by lack of efficacy (53.6 %) or intolerable adverse events (AEs; 44.8 %). Over a 24-month period, 72.7 % of patients were relapse free. Mean annual relapse rate decreased from 0.86 [95 % confidence interval (CI) 0.81–0.91] before the change to 0.32 (95 % CI 0.26–0.40; p < 0.0001) at last observation, while the progression of disability was halted, as the Kurtzke Expanded Disability Status Scale (EDSS) scores remained stable. Patients improved significantly (p < 0.05) on measures of fatigue, quality of life, depression, and cognition; mobility scores remained stable. The results indicate that changing RRMS patients to GA is associated with positive treatment outcomes.

The heritage of glatiramer acetate and its use in multiple sclerosis

“…Switching to glatiramer acetate Several trials have evaluated switching to GA from other MS therapies for safety and efficacy reasons [81][82][83]. For patients not responding to first line therapies GA can be offered as an alternative to so-called second line medications if there are concerns of tolerability/adverse events with the latter therapies.…”

“…For patients not responding to first line therapies GA can be offered as an alternative to so-called second line medications if there are concerns of tolerability/adverse events with the latter therapies. Most studies describe switches from IFNβ-1a or -1b to GA, reporting reductions in mean ARR after switching [81][82][83]. However, in those situations when the shift is due to failure of the previous treatment, results should be interpreted with caution because the regression to the mean phenomenon is a major concern.…”

Fatigue Improvement after Switching Multiple Sclerosis Treatment from Interferon-β to Glatiramer Acetate in Clinical Practice

“…Our study provides further insight into the effect of glatiramer acetate after treatment switch, supporting the improvement in MSrelated fatigue from the 6th month on glatiramer acetate. In addition, a recently published study has shown greater fatigue reduction in patients switching their immunomodulatory therapy as a result of lack of efficacy compared to those who switched due to adverse events [18] . These findings warrant further research to maximize fatigue benefits and prolong them in the long term.…”

“…Fatigue decrease over this first year was even sustained after 2 years of glatiramer acetate and was predicted by fatigue improvements achieved 6 months after starting the treatment [17] . Although similar reductions seem to occur in patients previously treated with other immunomodulatory/immunosuppressive therapies [17,18] , the evidence available is still limited, less consistent [16,17] , and potentially affected by secondary causes of fatigue such as depressive symptoms [16][17][18] .…”

Immunomodulatory treatments and cognition in MS

“…These Also Natalizumab, the first monoclonal antibody to treat highly active multiple sclerosis, with studies demonstrating better efficacy on disease activity and disability progression compared to interferons (e.g., Ref. 37,38 ), demonstrated in a reanalysis of the SENTINEL 39 and AFFIRM 40 phase III studies that treatment with Natalizumab reduced the risk of confirmed progression of cognitive deficits by 43% in comparison with a placebo. 41 The same applies to the STRATA extension study, where cognitive impairments were assessed monthly using the SDMT and MSNQ until the end of the study after 48 weeks.…”