The primary objective of the study is to determine which baseline and yearly response factors (clinical and para clinical) predict overall disease-free status at Month 12 and Month 24, and clinical disease-free status in subsequent Months 36 and 48. The secondary objectives are: To identify prognostic factors at Baseline that predict overall disease-free status at Month 12, and to assess if yearly overall disease-free response factors predict overall disease-free status at Month 24; To evaluate clinical disease-free status (relapse, Expanded Disability Status Scale [EDSS]) at each analysis time point of Months 12, 24, 36, and 48; To identify prognostic factors at Baseline that predict clinical disease-free status at Month 12, and to assess yearly clinical disease-free response factors that predict clinical disease-free status (relapse, EDSS) in subsequent years at Months 24, 36, and 48; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: ...
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Objective: To determine whether high-dose immunosuppressive therapy followed by autologous hematopoietic stem cell transplantation (HDIT/AHSCT) induces sustained remissions and prevents loss of neurologic function in active relapsing-remitting multiple sclerosis (RRMS). Background: HDIT/AHSCT has been assessed as a possible new therapeutic strategy in severe forms of MS. Small uncontrolled studies showed that about 60% to 70% of treated patients do not worsen in the follow-up period of at least 3 years. Responses were best in those with earlier disease stages. Since degenerative changes may contribute to loss of neurologic function in progressive MS, HDIT/AHSCT is being studied in RRMS. Methods: HALT-MS is an ongoing phase 2 clinical trial of HDIT/AHSCT with high-dose chemotherapy (BEAM) and antithymocyte globulin (ATG) in active RRMS (EDSS score, 3.0-5.5; =2 relapses on treatment and EDSS score worsening over past year). This is followed by transplantation with autologous CD34+-selected cells ...
Incomplete recovery from relapses in individuals with relapsing-remitting multiple sclerosis (RRMS) contributes to stepwise disability worsening, underscoring
Abstract Despite the existence of therapeutic guidelines, management of multiple sclerosis relapse remains heterogeneous. Optimisation of relapse outcome demands an improved understanding of the neurologists therapeutic attitude towards relapse management, which is the aim of this study. Neurologists from 13 multiple sclerosis centres completed a questionnaire every time they assessed multiple sclerosis relapses. The questionnaire requested a guided description of the relapses clinical characteristics and an indication of the prescribed therapy, supported with up to 3 out of 20 suggested reasons. Over 3 months, 368 questionnaires were collected. Median percentage (%) of 21 relapses resulting in a prescription was 88.9%. Corticosteroids represented the most frequent prescription. A short-course of high-dose intravenous methylprednisolone was the most used corticosteroid (73.7%). Treatment was administrated mainly in day case unit (80.0%) and at home (13.6%). A tapered therapy was prescribed to ...
of Myelin and Maintenance of Axonal Conduction in the MOG-induced EAE Mouse Model (Poster Session I -- P1.220; April 28; 3:00 p.m. EDT) -- Anti-murine CD52 Antibody Treatment Does Not Adversely Affect the Migratory Ability of Immune Cells (Poster Session I -- P1.222; April 28; 3:00 p.m. EDT) -- Successful Detection and Management of Immune Thrombocytopenia in Alemtuzumab-Treated Patients with Active Relapsing-Remitting Multiple Sclerosis (Poster Session II -- P2.198; April 29; 7:30 a.m. EDT) -- Thyroid Autoimmune Adverse Events in Patients Treated with Alemtuzumab for Relapsing-remitting Multiple Sclerosis: Four-year Follow-up of the CARE-MS Studies (Poster Session II -- P2.199; April 29; 7:30 a.m. EDT) -- Safety of Using Disease-modifying Therapy Post-alemtuzumab Treatment in Patients With Relapsing-remitting Multiple Sclerosis in the Core and Extension Phases of CAMMS223, CARE-MS I, and CARE-MS II Studies (Poster Session II -- P2.201; April 29; 7:30 a.m. EDT) -- Alemtuzumab Has Similar ...
The decision to start cladribine in MS depends on the degree of disease activity (as measured by number of relapses in the past year and T1 gadolinium-enhancing lesions on MRI), the failure of previous disease-modifying therapies, the potential risks and benefits and patient choice. In the UK, the National Institute for Clinical Excellence (NICE) recommends cladribine for treating highly active RRMS in adults if the persons has: rapidly evolving severe relapsing-remitting multiple sclerosis, that is, at least 2 relapses in the previous year and at least 1 T1 gadolinium-enhancing lesion at baseline MRI or relapsing-remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as 1 relapse in the previous year and MRI evidence of disease activity.[40] People with MS require counselling on the intended benefits of cladribine in reducing the risk of relapse and disease progression, versus the risk of adverse effects such as headaches, nausea and ...
There is a paucity of knowledge concerning erythrocytes in the aetiology of Multiple Sclerosis (MS) despite their potential to contribute to disease through impaired antioxidant capacity and altered haemorheological features. Several studies have identified an abundance of erythrocyte miRNAs and variable profiles associated with disease states, such as sickle cell disease and malaria. The aim of this study was to compare the erythrocyte miRNA profile of relapsing-remitting MS (RRMS) patients to healthy sex- and age-matched controls. Erythrocytes were purified by density-gradient centrifugation and RNA was extracted. Following library preparation, samples were run on a HiSeq4000 Illumina instrument (paired-end 100 bp sequencing). Sequenced erythrocyte miRNA profiles (9 patients and 9 controls) were analysed by DESeq2. Differentially expressed miRNAs were validated by RT-qPCR using miR-152-3p as an endogenous control and replicated in a larger cohort (20 patients and 18 controls). After logarithmic
BACKGROUND: The cerebellum is of potential interest for understanding adaptive responses in motor control in patients with multiple sclerosis because of the high intrinsic synaptic plasticity of this brain region. OBJECTIVE: To assess the relative roles of interactions between the neocortex and the cerebellum using measures of functional connectivity. METHODS: A role for altered neocortical-cerebellar functional connectivity in adaptive responses to injury from multiple sclerosis was tested using 1.5 T functional magnetic resonance imaging (fMRI) during figure writing with the dominant right hand in patients with predominantly early relapsing-remitting multiple sclerosis. RESULTS: Patients (n = 14) showed a more bihemispheric pattern of activation in motor cortex than healthy controls (n = 11). Correlations between task related signal changes in neocortical and cerebellar regions of interest were used as a measure of functional connectivity. Healthy controls showed strong functional connectivity between
Subcortical and Cortical Gray Matter Atrophy in a Large Sample of Patients with Clinically Isolated Syndrome and Early Relapsing-Remitting Multiple Sclerosis ...
Multiple sclerosis (MS) is a chronic inflammatory, demyelinating and neurodegenerative disorder. Since acetylcholine (ACh) is known to participate in the inflammatory response, we investigated the possible relationship between pro-inflammatory cytokines and acetylcholine levels in relapsing-remitting multiple sclerosis (RR-MS) patients. Levels of ACh and pro-inflammatory cytokines IL1-β and IL-17 were measured both in cerebrospinal fluid (CSF) and sera of 22 RR-MS patients in the relapsing phase and in 17 control subjects affected by other non-neurological diseases (OND). We observed higher levels of pro-inflammatory cytokines such as IL-1β and IL-17 in both CSF and serum of RR-MS patients compared to control subjects. Moreover, ACh levels were lower in CSF and serum of RR-MS patients compared to levels of control subjects. Although the relationship between high inflammatory cytokine levels and low ACh levels need to be further investigated in the future, our data suggest that IL-1β, and
To date, the only disease-modifying therapies shown to be effective in relapsing-remitting MS are the β-interferons (1, 2) and copolymer 1 (3). These therapies reduce relapse frequency by about one third and may slow disability progression. In this interesting Austrian study by Fazekas and colleagues, several comments are in order. Previous attempts at IVIg therapy in MS have yielded mixed results, and most studies have been uncontrolled or unblinded (4, 5). The primary end point in this study was the difference in the absolute change in EDSS score between groups rather than relapse frequency. These changes were very modest, although statistically significant. The authors chose to measure disability level at the end of the study rather than the more conservative sustained disability change, and this would tend to overstate the likelihood of progression in both treatment groups. Finally, magnetic resonance imaging was not done. Nonetheless, the findings from this work strongly suggest the need ...
Multiple sclerosis (MS) treatment in Latin America is a dynamic process due to the approval of new drugs worldwide, with particular emphasis on oral drugs at this moment. The introduction of these drugs in Latin American countries tends to be gradual, using data from local pharmacovigilance programs and often based on studies carried out in other continents. The potential patient population in the region presenting relapsing-remitting MS (RRMS) is estimated to be of the order of 50,000 people1, while its prevalence varies between 1.48 and 25 per 100, 000 inhabitants2-8. The main objectives of the present study were to update the therapeutic algorithm designed in 20109 and to assess the use of medications in several countries of the region. The present study focused on the first, second, and third-line therapeutic options, while a detailed and updated discussion on MS diagnosis can be found elsewhere10.. A literature search was carried out at PubMed database, using the key words multiple ...
Conclusion: SLCLA at 2.5% and 1.25% contrast levels correlates with retinal morphology and P100 latency and predicts some aspects of vision-related QoL in MS. More importantly, using a prospective cross-sectional approach we provide evidence that extending the MSFC by SLCLA as an additional visual component increases the performance of MSFC to capture MS-related disability. Longitudinal data on the relation between SLCLA, MSFC, and QoL will be available in the near future. (Source: BMC Neurology)
CONCLUSION: GA showed to be a cost-effective treatment option for the prevention of relapses in Spanish patients diagnosed with RRMS. When GA in monotherapy is compared with INF in monotherapy and IFN+GA combined, it may be concluded that the first is the dominant strategy. PMID: 24494728 [PubMed - as supplied by publisher] (Source: Methods of Information in Medicine)
Relapsing-remitting is the most common form of multiple sclerosis. Learn about symptoms, causes, diagnosis, long-term treatments, prognosis, and more.
Healthcare decision-making is complex and involves a wide range of factors. For the payer, Spanish NHS, it is very relevant to use a rational criterion when allocating resources, which is based on clinical evidence, efficiency and budget impact of the different therapeutic options available for the management of a given disease [14, 15]. In the case of MS, the availability of several drugs for its treatment, each with its particularities and specific profile, makes choosing the most appropriate treatment not easy for physicians, patients, or the payer.. In Spain, MS treatment drugs are dispensed at the hospital pharmacy. Pharmacological direct costs of management of this disabling disease accounts for 52% of all resources required for its management and directly impacts on the cost of each hospital [16]. The average budget impact for the cohort of patients with RRMS under treatment in Spain, considering all the options indicated for first-line treatment, represents an investment of €260 ...
Background Magnetic resonance imaging (MRI) is the best biomarker of inflammatory disease activity in relapsing remitting Multiple Sclerosis (RRMS) so far but the association with disability is weak. Appearance of new MRI-lesions is used to evaluate response to immunotherapies in individual patients as well as being the most common primary outcome in phase-2 trials. Measurements of brain atrophy show promising outcomes in natural cohort studies and some phase-2 trials. From a theoretical perspective they might represent irreversible neurodegeneration and be more closely associated with disability. However, these atrophy measurements are not yet established as prognostic factors in real-life clinical routine. High field MRI has improved image quality and resolution and new methods to measure atrophy dynamics have become available. Objective To investigate the predictive value of MRI classification criteria in to high/low atrophy and inflammation groups, and to explore predictive capacity of two
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Multiple sclerosis (MS) is an immune-mediated inflammatory demyelinating disease of the central nervous system (CNS) that is a leading cause of disability in young adults.The treatment of relapsing forms of MS is reviewed here, primarily focused on d
Evidence is accumulating on the involvement of B lymphocytes in the pathophysiology of MS. The contribution of B-cells and their secreted products to MS may relate to the abilities of B-cells to (1) differentiate into plasmocytes that produce antibodies; (2) function as antigen-presenting cells, contributing to T-cell activation; (3) produce effector cytokines that may modulate the local immune environment; (4) harbour the Epstein-Barr virus in a chronically activated state; and (5) play a role in the formation and maintenance of new lymphoid foci within the CNS (Waubant 2008). In people with RRMS, B-cells are critical for T-cell trafficking into the CNS and may alter the process by influencing chemokine production within the CNS (Piccio 2010). Interleukin-6 (IL-6) secretion is a major mechanism of B-cell driven pathogenesis in experimental autoimmune encephalomyelitis (EAE) and MS (Barr 2012). B-cell depletion affects antibody production, cytokine networks, and B-cell mediated antigen ...
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Changes of intestinal permeability (IP) have been extensively investigated in inflammatory bowel diseases (IBD) and celiac disease (CD), underpinned by a known unbalance between microbiota, IP and...
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LemtradaTM and AubagioTM are the proprietary names submitted to health authorities for the companys investigational multiple sclerosis agent alemtuzumab and teriflunomide respectively. About LemtradaTM (alemtuzumab) Lemtrada is a humanized monoclonal antibody being studied as a potential therapy for relapsing MS. Lemtrada targets the cell-surface glycoprotein CD52, which is highly expressed on T- and B-lymphocytes. Preliminary research suggests that Lemtrada initially depletes the T- and B-cells that may be responsible for the cellular damage in MS. This depletion of T- and B-cells is followed by a distinctive pattern of lymphocyte repopulation. Lemtrada appears to have little or no effect on other cells of the immune system. In addition to the completed CARE-MS I study, another Phase III trial, CARE-MS II, will evaluate Lemtrada against interferon beta-1a in relapsing-remitting multiple sclerosis patients who have relapsed while on therapy, with top-line results expected to be available in the ...
Category: Clinical-Studies, Movement-Disorders, Copaxone-Multiple-Sclerosis. Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Active Biotech (NASDAQ OMX NORDIC:ACTI) today announced new follow-up data evaluating the clinical safety of laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS) who were treated with laquinimod in Phase II, Phase III and open-label extension studies for two or more years. The pooled safety analysis of the Phase II LAQ/5063 and the Phase III ALLEGRO and BRAVO extension studies supports findings observed in the core studies where currently identified risks were observed within the first months of laquinimod treatment. These data will be presented as part of a platform presentation, September 12, 2014, at the MS Boston 2014: Joint ACTRIMS-ECTRIMS Meeting being held in Boston, Massachusetts. "These data may be important as they further support the clinical safety profile of laquinimod," said Michael Hayden, M.D., Ph.D., President of Global R&D and ...
This is an updated Cochrane review of the previous version published (Cochrane Database of Systematic Reviews 2004 , Issue 1 . Art. No.: CD004678. DOI: 10.1002/14651858.CD004678). Treatment with glatiramer acetate (Copaxone ®) of patients with Relapsing-Remitting (RRMS) and with Progressive Multiple Sclerosis (PMS) seems to have few beneficial effects in RRMS, while the drug is not effective in PMS patients. Previous studies indicate that glatiramer acetate, a synthetic drug, is effective in animal models of MS, and shows some benefits in MS patients. The objective of this review was to assess the efficacy of glatiramer acetate in RRMS and PMS patients.. Among the pertinent medical literature six studies met the criteria of the methodological quality necessary for their inclusion in this review. 540 RRMS patients and 1049 PMS patients contributed to this analysis. The data showed no beneficial effects on disease progression in both MS forms, a slight beneficial effect in the reduction of risk ...
Viele Studien über Multiple Sklerose (MS) haben bisher die Retina untersucht. Allerdings ist wenig über den Einfluss der MS auf die Cornea, welche durch den Nervus trigeminus innerviert wird, bekannt. Die Cornea ist diejenige Stelle im Körper, an welcher die neuronale Immunreaktion lokaler dendritischer Zellen auf Umwelteinflüsse stattfindet. Zielstellung Ziel dieser Studie ist es, die Wirkung der MS auf die kornealen Nervenfasern und die dendritischen Zellen des subbasalen Nervenplexus mittels in vivo Konfokalmikroskopie (IVCM) zu untersuchen. Methodika Mit dem Heidelberg Retina Tomographen® mit Rostock Cornea Modul wurden bei 26 MS-Patienten und dazu hinsichtlich Alter und Geschlecht gematchten gesunden Kontrollen die Dichte der kornealen Nervenfasern und die der dendritischen Zellen gemessen. Zusätzlich wurde die Schwere der MS-Erkrankung mit dem Multiple Sclerosis Functional Composite (MSFC) und der Expanded Disability Status Scale (EDSS) ermittelt. Des Weiteren wurde die Sehschärfe ...
Low-contrast letter acuity (LCLA) has emerged as the leading outcome measure to assess visual disability in multiple sclerosis (MS) research. As visual dysfunction is one of the most common manifestations of MS, sensitive visual outcome measures are important in examining the effect of treatment. Low-contrast acuity captures visual loss not seen in high-contrast visual acuity (HCVA) measurements. MS and disease-free controls have similar median HCVA, while MS patients have significantly lower LCLA. Deficits in LCLA and vision-specific quality of life are found many years after an episode of acute optic neuritis, even when HCVA has recovered. Studies reveal correlations between LCLA and the Expanded Disability Status Score (EDSS), Multiple Sclerosis Functional Composite (MSFC), retinal nerve fiber layer (RNFL) and ganglion cell layer plus inner plexiform layer (GCL + IPL) thickness on optical coherence tomography (OCT), brain magnetic resonance imaging (MRI), visual evoked potential (VEP), ...
Most drugs for the treatment of MS are for relapsing-remitting multiple sclerosis: this includes interferon beta-1a, interferon beta-1b, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, teriflunomide, and dimethyl fumarate. Interferon beta balances the pro and anti-inflammatory agents in the brain. It reduces the numbers of inflammatory cells that cross the blood brain barrier. Glatiramer acetate is similar to myelin basic protein and competes for presentation to T cells. Studies on interferon-beta-1b do not support that it slows progression but does reduce the number of relapses.. MS was originally considered an autoimmune disease triggered by exposure to environmental agents, such as viral infections and smoking habits. However, family and twin studies have clearly demonstrated that, like many other common neurological conditions, MS aggregates in families, highlighting a strong genetic component to disease that interacts with environmental factors. The index of heritability found in ...
This study explored the effect of glatiramer acetate (GA, 20 mg) on lesion activity using the 1.5 T standard MRI protocol (single dose gadolinium [Gd] and 5-min delay) or optimized 3 T protocol (triple dose of Gd, 20-min delay and application of an off-resonance saturated magnetization transfer pulse). A 15-month, phase IV, open-label, single-blinded, prospective, observational study included 12 patients with relapsing-remitting multiple sclerosis who underwent serial MRI scans (Days −45, −20, 0; the minus ign indicates the number of days before GA treatment; and on Days 30, 60, 90, 120, 150, 180, 270 and 360 during GA treatment) on 1.5 T and 3 T protocols. Cumulative number and volume of Gd enhancing (Gd-E) and T2 lesions were calculated. At Days −45 and 0, there were higher number (p | 0.01) and volume (p | 0.05) of Gd-E lesions on 3 T optimized compared to 1.5 T standard protocol. However, at 180 and 360 days of the study, no significant differences in total and cumulative number of new Gd-E
More than 85% of patients remained free from disability progression through years 1 to 9 of glatiramer acetate treatment, and 75.2% showed absence of disability progression for at least five consecutive years. Expanded Disability Status Scale (EDSS) scores were maintained, with most patients showing stable/improved EDSS and 92.6% sustaining EDSS ,6. Decreased annual relapse rates and increased proportion of relapse-free patients were maintained during the whole glatiramer acetate treatment compared to the year prior to its authorization (p,0.001). The number of gadolinium-enhanced T1-weighted lesions also decreased from pre-glatiramer-acetate assessment to last follow-up whilst on glatiramer acetate (p,0.05). ...
Background: Demyelinating events in relapsing-remitting multiple sclerosis (RRMS) can involve several locations in the central nervous system. We sought to determine if initial clinical demyelinating event (IDE) location predicts subsequent clinical relapse locations in early RRMS.. Methods: We identified all RRMS patients from two large MS clinics who were seen within 1 year of disease onset. Logistic regression was performed with the outcome defined as the second or third exacerbation location and the predictor defined as IDE±second event location.. Results: 195 patients with at least two clinical exacerbations were identified. There was an increased odds of a patients second relapse occurring in the spinal cord if the IDE was in the spinal cord (odds ratio (OR) = 3.79, 95% CI 2.06 to 7.00, p,0.001). There was more than a sixfold increase in the odds of a patients second relapse occurring in the optic nerve if the IDE was in the optic nerve (OR = 6.18, 95% CI 2.90 to 13.18, p,0.001). These ...
The phase III placebo-controlled BRAVO study assessed laquinimod effects in patients with relapsing-remitting MS (RRMS), and descriptively compared laquinimod with interferon beta (IFNβ)-1a (Avonex(®) reference arm). RRMS patients age 18-55 years with Expanded Disability Status Scale (EDSS) scores of 0-5.5 and documented pre-study relapse (≥ 1 in previous year, 2 in previous 2 years, or 1 in previous 1-2 years and ≥ 1 GdE lesion in the previous year) were randomized (1:1:1) to laquinimod 0.6 mg once-daily, matching oral placebo, or IFNβ-1a IM 30 μg once-weekly (rater-blinded design), for 24 months. The primary endpoint was annualized relapse rate (ARR); secondary endpoints included percent brain volume change (PBVC) and 3-month confirmed disability worsening. In all, 1,331 patients were randomized: laquinimod (n = 434), placebo (n = 450), and IFNβ-1a (n = 447). ARR was not significantly reduced with laquinimod [-18 %, risk ratio (RR) = 0.82, 95 % CI 0.66-1.02; p = 0.075] vs. placebo. ...
Interferon beta-1a (also interferon beta 1-alpha) is a cytokine in the interferon family used to treat multiple sclerosis (MS). It is produced by mammalian cells, while interferon beta-1b is produced in modified E. coli. Some claims have been made that Interferons produce about an 18-38% reduction in the rate of MS relapses. Interferon beta has not been shown to slow the advance of disability. Interferons are not a cure for MS (there is no known cure); the claim is that interferons may slow the progress of the disease if started early and continued for the duration of the disease. The earliest clinical presentation of relapsing-remitting multiple sclerosis is the clinically isolated syndrome (CIS), that is, a single attack of a single symptom. During a CIS, there is a subacute attack suggestive of demyelination which should be included in the spectrum of MS phenotypes. Treatment with interferons after an initial attack decreases the risk of developing clinical definite MS. Medications are ...
The association of white matter (WM) lesions and grey matter (GM) atrophy is a feature in relapsing-remitting multiple sclerosis (RRMS). The spatiotemporal distribution pattern of WM lesions, their relations to regional GM changes and the underlying dynamics are unclear. Here we combined parametric and non-parametric voxel-based morphometry (VBM) to clarify these issues. MRI data from RRMS patients with progressive (PLV, n = 45) and non-progressive WM lesion volumes (NPLV, n = 44) followed up for 12 months were analysed. Cross-sectionally, the spatial WM lesion distribution was compared using lesion probability maps (LPMs). Longitudinally, WM lesions and GM volumes were studied using FSL-VBM and SPM5-VBM, respectively. WM lesions clustered around the lateral ventricles and in the centrum semiovale with a more widespread pattern in the PLV than in the NPLV group. The maximum local probabilities were similar in both groups and higher for T2 lesions (PLV: 27%, NPLV: 25%) than for T1 lesions (PLV: 15%, NPLV
Biochemical changes associated with multiple sclerosis (MS), and its various clinical forms have not been characterized well. Therefore, we investigated the biochemistry of MS in relation to its natural history using targeted lipidomics platforms. Cross-sectional serum samples from 24 secondary progressive (SPMS), 100 relapsing remitting (RRMS), 19 primary progressive MS (PPMS), and 55 age-matched control subjects were analyzed by flow injection tandem mass spectrometry for very long chain fatty acid (VLCFA) containing phosphatidyl ethanolamines (PtdEtn), plasmalogen ethanolamines (PlsEtn) and for novel anti-inflammatory gastrointestinal tract acids (GTAs). Changes in analyte levels relative to healthy controls were correlated with the disease stage and disease duration. RRMS subjects having <13 years disease duration had elevated levels (p < 0.05) of anti-inflammatory metabolites (GTAs) and normal levels (p > 0.05) of mitochondrial stress biomarkers (VLCFA-PtdEtn), compared to controls. SPMS subjects
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This program will provide insights into multiple sclerosis and its symptoms, and discuss how to recognize them. Participants will also learn how to identify a relapse and discover some relapse treatment options that are available. ...
BACKGROUND Neutralizing antibodies (NAbs) to IFN-beta may have a detrimental effect on treatment response, but increasing IFN-beta dose could reduce their occurrence. The OPTimization of Interferon for MS (OPTIMS) study was a multicenter trial investigating clinical and MRI outcomes with the approved IFN-beta-1b dose (250 microg) and a higher dose (375 microg), s.c. every other day. OBJECTIVE To analyze the occurrence of NAbs and their effect on clinical and MRI response over a long-term (4-year) follow-up using cross-sectional and longitudinal statistical analysis. METHODS Relapses or disease progression was assessed open-label and MRI scans were performed serially during the first year of the study. Neutralizing antibodies were measured using the MxA protein production neutralization assay. RESULTS A total of 145 patients with relapsing-remitting multiple sclerosis from 14 centers participated in the study. Neutralizing antibody frequency was negatively associated with MRI treatment response,
In this trial, what I think was surprising was that the effect on disability is larger than the effect on relapses," said Dr. Giancarlo Comi, director of the Department of Neurology and Institute of Experimental Neurology at the Scientific Institute and University Vita-Salute San Raffaele in Milan. Severe relapses leading to hospitalization were reduced by 38%, he noted. "So you have to ask yourself, what is better at the end of 2 years - to have a better physical condition or an attack less?". The study authors note that 79% of the treated patients and 77% of the placebo patients completed follow up. The main reasons for discontinuation of the study were adverse events that included headache, abdominal pain, and back pain and transient elevations of liver enzymes.. Read: Scientists Block Multiple Sclerosis in Mice. The results from this study will be presented during the Clinical Trials Session at the American Academy of Neurology 63rd Annual Meeting in Honolulu.. Teva says that the company ...
OBJECTIVE: To examine alemtuzumab efficacy in treatment-naive patients with highly active relapsing-remitting MS (RRMS). BACKGROUND: In CARE-MS I (NCT00530348), alemtuzumab significantly reduced clinical and MRI disease activity versus SC IFNB-1a over 2 years in the highly active patient subgroup. Efficacy was durable through 4 years, despite most receiving no therapy since Month 12. DESIGN/METHODS: Patients received courses of alemtuzumab at baseline and Month 12 in the core study. Patients could enter the extension (NCT00930553), with as-needed retreatment for relapse or radiological activity, or another disease-modifying therapy (DMT) at the investigators discretion. Highly active disease was ≥2 relapses in year before randomization and ≥1 baseline gadolinium-enhancing lesion. No evidence of disease activity (NEDA) was absence of MRI (new gadolinium-enhancing and new/enlarging T2 lesions) and clinical (6-month confirmed disability progression or relapse) activity. Brain volume loss was ...
Previous work has demonstrated potentially adaptive cortical plasticity that increases with brain injury in patients with multiple sclerosis. However, animal studies showing use-dependent changes in motor cortex organization suggest that functional changes also may occur in response to disability. We therefore wished to test whether brain injury and disability lead to distinguishable patterns of activation with hand movement in patients with multiple sclerosis. By employing a passive as well as an active movement task, we also wished to test whether these changes were independent of voluntary recruitment and thus more likely to reflect true functional reorganization. Fourteen patients [Extended Disability Status Score (EDSS) 0-7.5] with relapsing-remitting multiple sclerosis were selected on the basis of pathology load and hand functional impairment for three study groups: group 1, low diffuse central brain injury (DCBI) as assessed from relative N-acetylaspartate concentration (a marker of axonal
2-year data positive in extension study, but no control group. An extension of the phase II BOLD study found sustained reductions in gadolinium-enhancing T1 and new or enlarging T2 lesions over 2 years with siponimod in patients with relapsing-remitting multiple sclerosis (RRMS), researchers reported.. The data also showed sustained reductions in combined unique active lesions (CUALs) when counting Gd-enhancing T1 lesions and new or enlarging T2 lesions together -- but only for two of the five doses used in the study, Ludwig Kappos, MD, of University Hospital in Basel, Switzerland, and colleagues reported online in JAMA Neurology.. The investigational treatment was well tolerated and there were no new safety signals, the researchers added.. Siponimod is an oral, once-daily selective sphingosine 1-phosphate receptor modulator, which is thought to be more selective than its cousin agent, fingolimod (Gilenya), which is approved to treat RRMS. Siponimod targets only the 1 and 5 receptor subtypes, ...
Patients with relapsing-remitting multiple sclerosis (RR-MS), the most common form of the disease, often have deficits in two neuropsychological functions, autobiographical memory (AM) and episodic future thinking (EFT), which impact quality of life. In a new study published in Restorative Neurology and Neuroscience, researchers report that training RR-MS patients in mental visual imagery can improve AM/EFT functioning.
Fingolimod is an effective treatment for active relapsing-remitting multiple sclerosis (MS). Discontinuation of therapy may be followed by recurrence of disease activity. Thus, female MS patients may be at risk of relapse during pregnancy after stopping fingolimod.. OBJECTIVES AND METHODS ...
Boys with onset of MS during puberty experienced an increased rate of relapse compared with boys with MS onset before or after puberty.
Teva Pharmaceuticals and Active Biotech announced results from the laquinimod Phase 3 ALLEGRO study in patients with relapsing-remitting multiple sclerosis (RRMS).