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      Tolerability, adverse events and compliance to glatiramer acetate in 28 patients with multiple sclerosis using the drug continuously for at least six months Translated title: Tolerabilidade, eventos adversos e aderência ao acetato de glatiramer em 28 pacientes com esclerose múltipla usando a droga continuamente por pelo menos seis meses

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          Abstract

          AIM: To assess tolerability, adverse events and compliance to treatment with glatiramer acetate in multiple sclerosis. METHOD: Review of patient records and individual interviews. RESULTS: 30 individuals residing in the coastal region of the State of São Paulo who had been in use of glatiramer acetate for at least 6 months were identified. From this group, 28 individuals came to regular consultations and were individually assessed, their complaints being noted down in confidential records. Ten patients reported systemic reactions to the drug. Four of them stopped the medication due to such reactions. Eight patients reported local reactions to the injections. Compliance with injections was achieved, although three patients reported forgetting the injection on a few days. CONCLUSION: We noticed a higher level of systemic adverse events in our patients than in reports in the literature.

          Translated abstract

          OBJETIVO: Avaliar tolerância, eventos adversos e aderência ao tratamento com acetato de glatiramer em esclerose múltipla. MÉTODO:Revisão de prontuários de pacientes e entrevistas individuais. RESULTADOS: 30 indivíduos residentes na região do litoral do Estado de São Paulo, que fizeram tratamento com acetato de glatirâmer por pelo menos 6 meses foram identificados. Deste grupo, 28 indivíduos compareceram a consultas regulares e foram avaliados individualmente, sendo suas queixas anotadas em prontuário confidencial. Dez pacientes relataram reações sistêmicas à droga. Quatro deles suspenderam o tratamento devido às reações. Oito pacientes relataram reação local às injeções. Aderência às injeções foi obtida, embora três pacientes admitam ter esquecido a injeção alguns poucos dias. CONCLUSÃO: Observamos um índice maior de reações sistêmicas em nossos pacientes do que o relatado na literatura.

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          Glatiramer acetate (Copaxone) therapy for multiple sclerosis.

          Glatiramer acetate (GA) (Copaxone(R)) is a worldwide-approved drug for the treatment of relapsing multiple sclerosis (MS), an autoimmune disease of the CNS. The drug is a synthetic copolymer with an amino acid composition based on the structure of myelin basic protein, one of the autoantigens implicated in the pathogenesis of MS and experimental autoimmune encephalomyelitis (EAE). Developed initially as a "tool" to study EAE, the drug unexpectedly inhibited disease and was subsequently developed for the treatment of MS. The drug has been shown in controlled clinical trials to significantly reduce relapse rate and progression of disability in MS with long-term efficacy, remarkable safety, and tolerability. Efficacy as measured by magnetic resonance imaging parallels its clinical benefits as manifested by a reduction in gadolinium-enhancing lesions and brain atrophy. The mechanism of action of the drug in humans is believed to involve the induction of glatiramer-reactive regulatory cells, including CD4+ and CD8+ T-cells. Glatiramer-reactive Th2 cells are believed to enter the brain and, through cross-reactivity with myelin antigens, produce bystander suppression, antiinflammatory effects, and neuroprotection.
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            Lipoatrophy in patients with multiple sclerosis on glatiramer acetate.

            Patients with relapsing remitting multiple sclerosis on the disease modifying therapy of glatiramer acetate may be experiencing an adverse reaction of lipoatrophy at the sites of their subcutaneous injections. The purpose of this study was to complete a full examination of the injection site areas for users of glatiramer acetate, and to examine the relationship between lipoatrophy and patient characteristics. Glatiramer acetate users were identified by means of chart review. Over six months, during regular clinic appointments, assessment included a full examination of injection site areas including visual inspection and manual palpation. Additional patient and clinical characteristics were obtained by means of chart review and patient questioning. Seventy-six patients had been or were current users of glatiramer acetate. Of these, 34 (45%) had evidence of lipoatrophy in at least one injection site area. All were female, and five had severe, nine had moderate and 20 had mild lipoatrophy. In some cases, lipoatrophy occurred within months of therapy initiation. Case reviews are included for five of the 34 patients, along with photographs of the lipoatrophy, a magnetic resonance image and comments on skin biopsies. Prevalence of lipoatrophy was much higher than expected. Possible reasons for this adverse reaction are explored and suggested treatment recommendations are reviewed. Lipoatrophy can be very disfiguring and is thought to be permanent, and the psychological impact can be significant. It is, therefore, important that patients be aware of the possibility of lipoatrophy, be able to identify it and discontinue injecting in areas where it is identified.
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              Glatiramer acetate for the treatment of multiple sclerosis.

              Glatiramer acetate (Copaxone, Teva Pharmaceuticals Ltd) is a collection of immunomodulatory, synthetic polypeptides indicated for the treatment of relapsing-remitting multiple sclerosis (RR MS). Preclinical and clinical studies provide an evolving understanding of the mechanisms by which glatiramer acetate exerts both immunological and potential neuroprotective effects that account for its clinical efficacy. The results of pivotal controlled clinical trials and long-term data, derived from organised extension studies, are evaluated in detail and supportive data from open-label comparison, combination treatment and therapeutic switch studies are considered in order to determine the place of glatiramer acetate among other approved therapies for RR MS. The efficacy of glatiramer acetate is stable or may increase over time and the drug has a favourable side effect profile. Glatiramer acetate is an appropriate first-line immunomodulatory therapy for RR MS.
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Journal
                anp
                Arquivos de Neuro-Psiquiatria
                Arq. Neuro-Psiquiatr.
                Academia Brasileira de Neurologia - ABNEURO (São Paulo )
                1678-4227
                September 2005
                : 63
                : 3b
                : 738-740
                Affiliations
                [1 ] CEREM Litoral Paulista
                [2 ] UNIMES Brazil
                [3 ] UNIMES
                Article
                S0004-282X2005000500002
                10.1590/S0004-282X2005000500002
                16258646
                875fc1d6-223c-4621-a251-9bc109514a08

                http://creativecommons.org/licenses/by/4.0/

                History
                Product

                SciELO Brazil

                Self URI (journal page): http://www.scielo.br/scielo.php?script=sci_serial&pid=0004-282X&lng=en
                Categories
                NEUROSCIENCES
                PSYCHIATRY

                Neurosciences,Clinical Psychology & Psychiatry
                multiple sclerosis,glatiramer acetate,copaxone,esclerose múltipla,acetato de glatiramer

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