Five-year outcome in the copaxone observatory: a nationwide cohort of patients with multiple sclerosis starting treatment with glatiramer acetate in France

Abstract

The benefits provided by disease-modifying treatments in multiple sclerosis have been demonstrated in clinical trials, but the extent to which they can be extrapolated to everyday care is less clear, as are the long-term benefits of treatment. The objective of this prospective observational cohort study performed in France was to evaluate the effectiveness and safety of glatiramer acetate in patients with relapsing-remitting multiple sclerosis over a 5-year period. All neurologists in France were invited to participate and enroll adult patients starting a first treatment with brand glatiramer acetate 20 mg. Given the observational nature of the study, no fixed study visits were imposed; consultations took place according to the investigator's normal practice. Occurrence of disease exacerbations and adverse events was documented and neurological disability evaluated with the EDSS at each consultation. Overall, 852 patients were analysable and 269 took glatiramer acetate continuously for 5 years. Median treatment duration was 3.4 years. Principal reasons for discontinuation were inadequate efficacy (38.9%), local tolerability (22.6%) and personal convenience (21.3%). Age, employment status, baseline EDSS score and number of previous exacerbations were variables associated with treatment persistence. The annualised exacerbation rate (5 years) was 0.41 [95% CI 0.39-0.44]; 316 patients (37.2%) remained exacerbation-free throughout. The risk of confirmed disability worsening (5 years) was 43.8% [95% CI 39.9-47.9%]. The most frequent adverse drug reactions were local injection site reactions (584 patients; 68.5%) and systemic immediate post-injection reactions (168 patients; 19.7%). Overall, these findings are consistent with those of previous clinical trials.

Keywords: Disease-modifying treatment; France; Glatiramer acetate; Observational study; Relapsing–remitting multiple sclerosis.

Fig. 1

Patient distribution. GA glatiramer acetate, FU follow-up

Fig. 2

Probability of persistence with AG treatment over the 5-year study period. Data are presented as a Kaplan–Meier survival curve

Fig. 3

Patient variables independently associated with treatment persistence (a; N = 715) and with clinical response (b; N = 661) in patients treated with glatiramer acetate. Data are presented as hazard ratios or odds ratios with their 95% confidence intervals

Fig. 4

Annualised exacerbation rate over the course of the study

Fig. 5

Time to confirmed worsening of disability: Kaplan–Meier survival analysis

Fig. 6

Non-serious adverse drug reactions documented during the study