Official websites use. Share sensitive information only on official, secure websites. 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. Occurrence of disease exacerbations and adverse events was documented and neurological disability evaluated with the EDSS at each consultation.
Overall, patients were analysable and took glatiramer acetate continuously for 5 years. Median treatment duration was 3. Principal reasons for discontinuation were inadequate efficacy 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. The risk of confirmed disability worsening 5 years was The most frequent adverse drug reactions were local injection site reactions patients; Overall, these findings are consistent with those of previous clinical trials.
The online version of this article Keywords: Relapsing—remitting multiple sclerosis, Disease-modifying treatment, Glatiramer acetate, France, Observational study. Multiple sclerosis is a progressive disabling neurological disease, which affects around people in France [ 1 ].
It is associated with considerable burden of disease [ 2 ] and is the principal cause of non-traumatic irreversible disability in young adults. Over the past 2 decades, a number of disease-modifying treatments DMTs for MS have been introduced, which provide a reduction in exacerbation rates and disease activity measured by MRI, together with a possible reduction of disability progression in the medium-term.
