Objective. To seek evidence that Timexon (BCD-063, glatiramer acetate, Biocad, Russia) and Copaxone-Teva (Teva Pharmaceuticals Ltd., Israel) have similar efficacies in patients with remitting multiple sclerosis. Materials and methods. A multicenter, double-blind, placebo-controlled, comparative, randomized, phase III study included 158 patients with confirmed diagnoses of remitting multiple sclerosis. Patients were randomized to the BCD-063, Copaxone-Teva, and placebo groups at a ratio of 2:2:1. Results and conclusions. Efficacy analysis at 48 weeks of treatment demonstrated that there were no differences between the BCD-063 and Copaxone-Teva groups in terms of MRI parameters or exacerbation frequency. Assessment of the primary endpoint (number of MRI-confirmed exacerbations per patient per year) showed that the mean number of exacerbations was 0.098361 (0.351422) in the BCD-063 group, 0.098361 (0.351422) in the Copaxone-Teva group, and 0.178571 (0.390021) in the placebo group. Assessments on the EDSS and MSFC also demonstrated that there were no differences between the BCD-063 and Copaxone-Teva groups. Both BCD-063 and Copaxone-Teva had favorable safety profiles. These data provide evidence of the therapeutic equivalence of BCD-063 (Biocad, Russia) and Copaxone-Teva, which is an important aspect for further introduction of the reproduced glatiramer acetate formulation into the treatment of multiple sclerosis.
Functional MRI (fMRI) is a new method promoting the study of brain functions and relationships between physiological activity and anatomical location. At present cortical reorganization is regarded as one of possible factors of recovery or maintenance of function in the presence of irreversible brain damage in multiple sclerosis (MS). Functional cortical changes have been demonstrated in all MS phenotypes using different fMRI paradigms, but the majority of studies were focused on the motor system. It was shown variability of functional reorganization of the motorcortex in MS depending on the stage of the disease. Cortical reorganization plays a role in limiting the impact of structural damage in MS; conversely, failure of these plastic mechanisms may cause irreversible disability upon the disease progression. Future dynamic fMRI studies will allow to access changes of functional brain activity in different disease severity and different extent of regress of MS symptoms. The improvement of cortical adaptive plasticity represents a potentially significant direction of rehabilitation in MS patients.
Motor disorders are a frequent syndrome in multiple sclerosis(MS), leading to severe disability, possibly associated with inefficiencyof adaptive mechanisms, probably because of widespreadstructural changes. Hand palsy with fine motor skillsdamage influences greatly on quality of life, because handfunction plays an important role in everyday activities andworking practices. Thus the aim of the study was to investigatefunctional and structural features of hand palsy in homogenoussample of MS patients during the relapse and in three months.Data were acquired from 25 relapsing-remitting MS patientsduring relapse also characterized by unilateral light hand palsy,and in three months. 12 age-matched healthy controls enteredthe control group. All patients underwent neurologica examination,including nine-hole peg test and dynamometry, andmagnetic resonance imaging of cervical spine and brain,including functional MRI and diffusion tensor imaging (DTI)sequences. All patients had lesions in spinal cord on cervicalspine MRI. fMRI data analysis during relapse showed differentlydirected activation changes and allowed to divide allpatients in two subgroups. These subgroups differed from eachother and control group by deep sensitivity and DTI values. Inthree months patients in the first subgroup had less completefine motor skills recovery, which was accompanied also bypreservation of activation changes and deep sensitivity asymmetryin comparison with the second subgroup. Received dataallow us to assume that clinically similar palsy, caused by spinalcord lesion, could be characterized by greater or lesser sensationimpairment contribution. In three months heterogeneousstructural and functional changes were observed, depending,possibly, on initially different pathologic mechanisms.Revealed differences should be taken into consideration whilerehabilitation planning.
In the paper, the results of 1-year treatment with avonex, a newimmunomodulator from the group of interferons b, in 34patients with relapsing remitting multiple sclerosis have beenreported. In the treated patients it was shown significantdecrease of the activity of the pathological process, which wasevidenced by reduction of the severity of exacerbations and therelapse rate. The decrease of disability of patients with multiplesclerosis (by EDSS score) was revealed. In general, one cannotice good tolerability of avonex.
Results of the two-year treatment with avonex of 34 patients withrelapsing remitting multiple sclerosis are summarized. This studyprovides evidence for the significant decrease in activity of thepathological process in patients treated with avonex, which is confirmedby the reduction of the relapse rate and the increase of the proportion of patients remaining exacerbation-free. The decreaseof the EDSS score has also been shown. In general, avonex was toleratedwell in patients under study.
UNLABELLED:Spinal cord involvement is frequent in multiple sclerosis (MS) but the correlation between spinal cord damage on conventional MRI and clinical symptoms is not always obvious. Diffusion tensor imaging (DTI) is a sensitive technique for revealing tissue damage.OBJECTIVE:to investigate spinal cord DTI changes in MS patients during the relapse and in the follow-up.MATERIAL AND METHODS:Data were acquired from 25 patients with relapsing-remitting MS during the relapse characterized by unilateral light hand palsy, in three and twelve months after it. All patients underwent full neurological examination and MRI including conventional head and neck MRI and DTI of the brain and upper spinal cord in the sagittal plane. Twelve healthy subjects entered the control group.RESULTS AND CONCLUSION:Spinal cord sagittal DTI provides a reliable information about significant changes in MS patients compared tothe control group both inside demyelinating lesions and in the normal appearing spinal cord. These differences are preserved both in 3 and 12 months after the relapse and together with clinical recovery create evidence of functional compensatory mechanisms development. A tendency towards DTI parameters normalization together with faster fine motor skills recovery in patients without the asymmetrical decrease in vibration sense shows an important role that afferentation plays in recovery after the relapse.
Poster: "ECR 2014 / B-1015 / Longitudinal DTI changes in multiple sclerosis patients with different cortical reorganization patterns" by: "S. Morozova, A. Peresedova, V. Bryukhov, O. Trifonova, M. Krotenkova, I. Zavalishin; Moscow/RU"
Movement disorders are frequent syndrome in multiple sclerosis /INS;(MS), leading to severe disability. Early predictors of clinical outcome are important for optimization of rehabilitation therapy. Thus the aim of the study was to investigate cortical reorganization pattern during relapse and in follow-up as a predictor of clinical outcome.