Diet help multiple sclerosis
(2016) Safety and efficacy of dimethyl fumarate in multiple sclerosis: a multi-center observational study. The incidence of serious infections was 2% in all the groups ( Table 3, and Table S7 in the Supplementary Appendix ). CrossRef 23 Danilo Di Bona, Marcello Albanesi, Lucia A. CrossRef 59 Hao Wu, Lili Kong, Yi Tan, Paul N. Suneetha, Rajeswari K. (2016) Fumaric Acid Esters Attenuate Secondary Degeneration Following Spinal Cord Injury. MRI End Points As compared with placebo, BG-12 reduced the number of new or enlarging hyperintense lesions on T 2 -weighted images at 2 years by 85% with the twice-daily regimen and by 74% with the thrice-daily regimen (P Table 2 ). (2016) Comparison of LC-UV and LC-MS methods for simultaneous determination of teriflunomide, dimethyl fumarate and fampridine in human plasma: application to rat pharmacokinetic study. CrossRef 7 Shin Ebihara, Hideaki Tajima, Masao Ono. (2016) Chemical proteomic map of dimethyl fumarate-sensitive cysteines in primary human T cells. (2016) Safety and Tolerability of Delayed-Release Dimethyl Fumarate Administered with Interferon Beta or Glatiramer Acetate in Relapsing-Remitting Multiple Sclerosis. M. (2016) Severe articular and musculoskeletal pain: An unexpected side effect of dimethyl-fumarate therapy for multiple sclerosis. Birgander, J. Hagemans, W. 0% of patients receiving placebo and 33. Teijaro, B. (2016) Identification of Potential Therapeutics to Conquer Drug Resistance in Salmonella typhimurium: Drug Repurposing Strategy. (2016) Activation of the Nrf2 signaling pathway in usnic acid-induced toxicity in HepG2 cells. Journal of Enzyme Inhibition and Medicinal Chemistry, 1-11. Key exclusion criteria were progressive forms of multiple sclerosis, 9 another major disease that would preclude participation in a clinical trial, abnormal results on prespecified laboratory tests, or recent exposure to contraindicated medications (Table S1 in the Supplementary Appendix ). Frau, G. Lally. (2015) Dimethyl fumarate treatment alters circulating T helper cell subsets in multiple sclerosis. All the authors participated in writing subsequent drafts of the manuscript and made the decision to submit it for publication. Burman, C. CrossRef 10 Yang Yao, Weimin Miao, Zhijia Liu, Wei Han, Kaibin Shi, Yi Shen, Handong Li, Qiang Liu, Ying Fu, DeRen Huang, Fu-Dong Shi. Bramer, H. Hafler. (2016) Neurotherapeutic Strategies for Multiple Sclerosis. Zamvil. Abualmelh, S. (2016) Nuclear factor erythroid 2-related factor 2 is a critical target for the treatment of glucocorticoid-resistant lupus nephritis. Using a chi-square test with a two-sided alpha level of 0. 62% in the placebo group) (Table S4 in the Supplementary Appendix ). A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. 12 Declaration of Helsinki — ethical principles for medical research involving human subjects. A total of 952 patients (77%) completed the study (78% in the placebo group and 77% in each of the BG-12 groups) (Fig. Klotz. Clinical Research in Neurology. Coghe, L. CrossRef 9 Ruihe Lin, Jingli Cai, Eric W. Data were collected by the investigators and were analyzed by the sponsor. The investigators and sponsor agreed to maintain data confidentiality during the study. The incidence of serious adverse events was similar across the study groups, with relapse of multiple sclerosis the most frequently reported event ( Table 3, and Table S6 in the Supplementary Appendix ). Disability progression was defined as at least a 1. (2016) Transient hair loss during treatment with dimethyl-fumarate for multiple sclerosis. Bennett, Gary Cutter, Kaylan Fenton, Fred Lublin, Dorothy Northrop, David Rintell, Bryan D. Mao, Y. The adverse events that occurred most frequently in patients who received BG-12 were flushing and gastrointestinal events, with the highest incidence of these events in the first month. (2016) Management of multiple sclerosis in daily practice for general neurologist and healthcare professionals. Tolleson, Lei Guo. (2016) Comparative efficacy of disease-modifying therapies for patients with relapsing remitting multiple sclerosis: Systematic review and network meta-analysis. The estimated proportion of patients with progression of disability was 27% with placebo, 16% with twice-daily BG-12, and 18% with thrice-daily BG-12. (2016) The IBD Disability Index should become a Major Secondary Endpoint in Clinical Practice and in Clinical Trials. 0 or higher or at least a 1. CrossRef 63 David E. The incidences of infections and serious infections were similar across all groups. CrossRef 95 Emma D. (2016) Comparing outcomes from clinical studies of oral disease-modifying therapies (dimethyl fumarate, fingolimod, and teriflunomide) in relapsing MS: Assessing absolute differences using a number needed to treat analysis. CrossRef 73 Francesco Antonio Losavio, Matteo Lucchini, Chiara De Fino, Massimiliano Mirabella, Viviana Nociti. F. Al-Hashel, R. (2016) Efficacy, effectiveness and safety of fumaric acid esters in the treatment of psoriasis: a systematic review of randomized and observational studies. A. Cabras, J. Xie, B. CrossRef 15 Balasundaram Preethi, Veerappapillai Shanthi, Karuppasamy Ramanathan. The baseline demographic and disease characteristics of patients in the MRI cohort were similar to those of patients who were not in the MRI cohort and to those of the overall study population (Table S2 in the Supplementary Appendix ). The annualized relapse rate at 2 years was 0. Constantinescu, Radu Tanasescu. Taitano, G. CrossRef 104 Jens Ingwersen, Orhan Aktas, Hans-Peter Hartung. The incidences of flushing and gastrointestinal events were highest in the first month of the study and decreased thereafter (Fig. Deeks. Defining the clinical course of multiple sclerosis: results of an international survey. CrossRef 6 Keren Regev, Howard L. For the analyses of MRI end points in these patients, the data before the switch were used and then data after the rescue therapy was initiated were imputed with the use of a constant rate assumption. CrossRef 51 Pierre Abramowski, Susanne Krasemann, Thomas Ernst, Claudia Lange, Harald Ittrich, Michaela Schweizer, Axel R. 0-point increase on the EDSS in patients with a baseline score of 1. , Raja Rajeswari K. Martino Neumann, Robert Zietse, Hok Bing Thio. 1,5 It is difficult to determine whether the therapeutic effect of BG-12 stems predominantly from immunomodulatory mechanisms or from neuroprotective mechanisms. All statistical tests were two-sided, with an overall type I error rate of 0. Download or order the MS-UK newly diagnosed booklet today. All the authors had early access to the data, participated in person in the data analysis and interpretation, and vouch for the accuracy and completeness of the data and the statistical analysis and for the fidelity of the study to the protocol. Source Information From the Department of Neurology, St. 16 PRISMS Study Group. (2016) Advances in and Algorithms for the Treatment of Relapsing-Remitting Multiple Sclerosis. We are closed between December 23 and January 03. CrossRef 44 Siobhan Leary, Gavin Giovannoni, Robin Howard, David Miller, Alan Thompson. Vucic,. 6% of patients receiving BG-12 would have at least one relapse during the study. Because our trial was not a head-to-head study comparing BG-12 with an approved multiple sclerosis therapy, a comparison of the efficacy and safety of BG-12 with those of other therapies is not within the scope of this article. The most common infections were nasopharyngitis, upper respiratory tract infection, urinary tract infection, and influenza. K. 05. 46% with placebo, P 2 -weighted hyperintense lesions (P Full Text of Results. G. Dupuy, Shahamat Tauhid, Shelley Hurwitz, Renxin Chu, Fawad Yousuf, Rohit Bakshi. Holian, A. Newsome. R. Walker, Megan Weigel, Kathleen Zackowski, David E. Kobayashi, Masayuki Yamamoto. CrossRef 50 Marta Simone, Tanuja Chitnis. Menzies, N. Forslin, T. (2016) The cost-effectiveness of delayed-release dimethyl fumarate for the treatment of relapsing-remitting multiple sclerosis in Canada. W. F. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee (see the Study Oversight section in the Supplementary Appendix ), whose members reviewed a standardized set of blinded clinical records (which did not include MRI data) from the treating and examining neurologists. CrossRef 116 C. Sormani, A. Scannevin. Lorefice, G. (2016) The Effect of Dimethyl Fumarate on Cerebral Gray Matter Atrophy in Multiple Sclerosis. Adverse events that occurred more frequently in patients receiving BG-12 than in patients receiving placebo included flushing, gastrointestinal events (e. Sharfuddin, S. Leist. Overall, the incidence of renal adverse events was balanced across the study groups (21% in the placebo group, 22% in the twice-daily BG-12 group, and 25% in the thrice-daily BG-12 group). CrossRef 42 Claire McCarthy, John Thorpe. Statistical Analysis All efficacy analyses were performed on data from the intention-to-treat population, which included all patients who underwent randomization and who received at least one dose of the study drug. 2016. Members of the advisory committee and the data and safety monitoring committee (see the Study Oversight section in the Supplementary Appendix, available with the full text of this article at NEJM. (2016) The cost-effectiveness of disease-modifying therapies for the treatment of relapsing-remitting multiple sclerosis. (2016) Nrf2 suppresses macrophage inflammatory response by blocking proinflammatory cytokine transcription. To maintain concealment of the study-group assignments, each study center used separate examining and treating neurologists (all of whom remained unaware of the assignments throughout the trial). CrossRef 110 Saneea Almas, Jesse Vance, Teresa Baker, Thomas Hale. Multiple Sclerosis and Demyelinating Diseases. Vercellotti. The baseline demographic and disease characteristics were generally well balanced across the study groups ( Table 1 Table 1 Baseline Characteristics of the Intention-to-Treat Population. CrossRef 118 Nele Dammeier, Victoria Schubert, Till-Karsten Hauser, Antje Bornemann, Felix Bischof. The primary end point was analyzed with the use of a Cox proportional-hazards model, adjusted for baseline EDSS score, age, region, and number of relapses in the year before study entry. Randomization was performed centrally and was stratified according to site. There were decreases in lymphocyte counts and elevations in liver aminotransferase levels in the patients who received BG-12. Edwards, Jing L. Soelberg Sorensen. CrossRef 93 Kazumasa Yokoyama, Nobutaka Hattori. Leussink, H. A sensitivity analysis of all protocol-defined relapses, rather than only relapses confirmed by an independent neurologic evaluation committee, showed results that were consistent with those of the main analysis. The first draft of the manuscript was written by the first author and the senior author representing the sponsor, with support from medical writers from Infusion Communications, who were funded by the sponsor. (2016) Consensus recommendations for the diagnosis and treatment of multiple sclerosis in Kuwait. Reference Module in Chemistry, Molecular Sciences and Chemical Engineering. A sequential (closed) testing procedure was used to control the overall type I error rate due to multiple comparisons. Balak, S. (2016) Dimethyl fumarate treatment induces adaptive and innate immune modulation independent of Nrf2. Reisinger, Hans-Peter Hartung, Uwe K. (2016) Role of dimethyl fumarate in oxidative stress of multiple sclerosis: A review. (2016) Paediatric Multiple Sclerosis: Update on Diagnostic Criteria, Imaging, Histopathology and Treatment Choices. Cocco. Our Helpline is open from 9am - 5pm, Monday to Friday. M. (2016) Persistency, medication prescribing patterns, and medical resource use associated with multiple sclerosis patients receiving oral disease-modifying therapies: a retrospective medical record review. (2016) Desensitization for immediate hypersensitivity to oral dimethyl fumarate (Tecfidera). Nicholas Brenton, Brenda L. 5-point increase in patients with a baseline score of 0, with the increased score sustained for at least 12 weeks. Results Patients A total of 1237 patients underwent randomization, of whom 1234 received at least one dose of the study drug (intention-to-treat population). ). 19 in the thrice-daily BG-12 group, as compared with 0. (2016) The challenge of comorbidity in clinical trials for multiple sclerosis. Kobayashi, Takafumi Suzuki, Ryo Funayama, Takeshi Nagashima, Makiko Hayashi, Hiroki Sekine, Nobuyuki Tanaka, Takashi Moriguchi, Hozumi Motohashi, Keiko Nakayama, Masayuki Yamamoto. (2016) Fumaric acid esters promote neuronal survival upon ischemic stress through activation of the Nrf2 but not HIF-1 signaling pathway. On the basis of data from another clinical trial in which an active drug was compared with placebo in patients with multiple sclerosis, 13 we estimated that 48. Cananau, Y. Table 1 Baseline Characteristics of the Intention-to-Treat Population. Kirby, J. Posevitz-Fejfar, H. You can contact our MS advisors between 9am and 5pm. Call for free on 0800 783 0518 or use our live web chat service. (2016) Dimethyl Fumarate and Monomethyl Fumarate Promote Post-Ischemic Recovery in Mice. Downer. Miller, Catherine Dive-Pouletty, Steven Hass, Karthinathan Thangavelu, Thomas P. CrossRef 67 Jiemeng Lin-Holderer, Lexiao Li, Daniel Gruneberg, Hugo H. (2016) Drug-induced Fanconi syndrome associated with fumaric acid esters treatment for psoriasis: a case series. (2016) The Use of Oral Disease-Modifying Therapies in Multiple Sclerosis. (2016) Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. BG-12 also significantly reduced disease activity as assessed by means of MRI findings. CrossRef 78 Ulf Schulze-Topphoff, Michel Varrin-Doyer, Kara Pekarek, Collin M. (2016) Utilization of Dimethyl Fumarate and Related Molecules for Treatment of Multiple Sclerosis, Cancer, and Other Diseases. (2016) Salidroside Suppresses HUVECs Cell Injury Induced by Oxidative Stress through Activating the Nrf2 Signaling Pathway. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. CrossRef 37 M. Lundy, Q. (2016) Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis. Fenu, F. (2016) Therapeutic Approach to the Management of Pediatric Demyelinating Disease: Multiple Sclerosis and Acute Disseminated Encephalomyelitis. The analytic models included adjustments for region and baseline characteristics, including EDSS score, age, relapse rate, and number or volume of baseline lesions, as appropriate. Sensitivity analyses were performed on the primary end point. The observed reductions in the number of brain MRI lesions, the rate of relapse, and the rate of disability progression with BG-12 are consistent with its beneficial effects on the inflammatory damage associated with multiple sclerosis. A. (2016) Synthesis of Keap1-phosphorylated p62 and Keap1-Nrf2 protein-protein interaction inhibitors and their inhibitory activity. CrossRef 68 Pierre-Paul Axisa, David A. Therapies for multiple sclerosis. D. (2016) Safety concerns and risk management of multiple sclerosis therapies. A. Unscheduled visits were conducted as needed to evaluate suspected relapses. Other end points included the annualized relapse rate, the time to confirmed progression of disability, and findings on MRI. In addition, the safety profile of BG-12 in the DEFINE study was similar to that observed in the CONFIRM study. Fox, Andrew Chan, Annie Zhang, James Xiao, Dane Levison, James B. Hoepner. Zettl. CrossRef 61 Si Chen, Zhuhong Zhang, Tao Qing, Zhen Ren, Dianke Yu, Letha Couch, Baitang Ning, Nan Mei, Leming Shi, William H. (2016) Immunological treatment of multiple sclerosis. To ensure that the study-group assignments would not be revealed, patients were instructed to take the assigned study drug at least 4 hours before study visits, in case patients in the BG-12 groups had a side effect of flushing. The absence of the pro-antioxidant transcription factor Nrf2 exacerbated experimental autoimmune encephalomyelitis. (2016) Multiple sclerosis. org) collaborated with the sponsor, Biogen Idec, to develop the protocol and monitor the ongoing study. (2016) Predictors of Response to Multiple Sclerosis Therapeutics in Individual Patients. CrossRef 77 Jonathan Calkwood, Timothy Vollmer, Robert J. The Journal of Allergy and Clinical Immunology: In Practice.
CrossRef 86 Martin Diebold, Tobias Derfuss. Larger percentages of patients in the BG-12 groups than in the placebo group were free from gadolinium-enhancing lesions on MRI at 2 years (93% in the twice-daily BG-12 group and 86% in the thrice-daily BG-12 group vs. Thio, H. Fumaric acid esters exert neuroprotective effects in neuroinflammation via activation of the Nrf2 antioxidant pathway. (2016) Current multiple sclerosis treatments have improved our understanding of MS autoimmune pathogenesis. I. CrossRef 19 Marika Cordaro, Giovanna Casili, irene paterniti, salvatore cuzzocrea, Emanuela Esposito. Neumann. The primary end point was the proportion of patients who had a relapse by 2 years. Gold, R. Among patients who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis of the clinical end points. B. Vembu, K. Proceedings of the National Academy of Sciences 113:17, 4777-4782. (2016) C66 ameliorates diabetic nephropathy in mice by both upregulating NRF2 function via increase in miR-200a and inhibiting miR-21. Ismail, A. CrossRef 56 Wenqing Su, Anuraag Kansal, Colin Vicente, Baris Deniz, Sujata Sarda. Giacomini, Virender Bhan, Marika Hohol, Robyn Schecter. Laboratory Assessments and Other Monitoring In the BG-12 groups, as compared with the placebo group, the mean white-cell count and lymphocyte count decreased over the first year and then plateaued, with mean values remaining within normal limits (Fig. Bernat. C. Registered Company Name: Multiple Sclerosis-UK Limited, trading as MS-UK Company Number: 2842023 Registered Charity Number: 1033731. Fitzpatrick, Eric J. Alanine aminotransferase levels that were three or more times the upper limit of the normal range were seen in 3% of the patients in the placebo group and in 6% of the patients in each BG-12 group, with the difference driven mainly by differences at week 4. CrossRef 97 Rebecca Straus Farber, Asaff Harel, Fred Lublin. (2016) An unusual infection in MS patient treated with dimethyl fumarate: A case report of omphalitis. Wiendl, L. Backus, A. 2015. CrossRef 39 Meng-Chen Lu, Jian-Ai Ji, Zheng-Yu Jiang, Qi-Dong You. Ostrow, S. Safety analyses were summarized with the use of descriptive statistics for all patients who received at least one dose of the study drug. 17 in the twice-daily BG-12 group and 0. (2016) Comparative efficacy and discontinuation of dimethyl fumarate and fingolimod in clinical practice at 12-month follow-up. Fallah Arani, E. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. A placebo-controlled and active comparator phase III trial (BRAVO) for relapsing-remitting multiple sclerosis. CrossRef 20 Duygu Bozkaya, Terrie Livingston, Kristen Migliaccio-Walle, Tanner Odom. Altman, J. Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Marrosu, E. Loi, M. CrossRef 70 Maria Rasenack, Tobias Derfuss. CrossRef 52 D. (2016) The future of multiple sclerosis treatments. Hajdarbegovic, C. CrossRef 29 Zheng-Yu Jiang, Meng-Chen Lu, Qi-Dong You. The examining neurologists conducted neurologic assessments, including assessment of the EDSS score, whereas the treating neurologists were responsible for all aspects of patient care, including the treatment of relapses and other disease symptoms. g. CrossRef 58 I-Jun Chou, Huei-Shyong Wang, William P. 2017. (2016) Identification of an adaptor protein that facilitates Nrf2-Keap1 complex formation and modulates antioxidant response. M. (2016) Dimethyl fumarate alters microglia phenotype and protects neurons against proinflammatory toxic microenvironments. Gross, A. P. CrossRef 14 Daisuke Yasuda, Mao Nakajima, Akihiro Yuasa, Rika Obata, Kyoko Takahashi, Tomoyuki Ohe, Yoshinobu Ichimura, Masaaki Komatsu, Masayuki Yamamoto, Riyo Imamura, Hirotatsu Kojima, Takayoshi Okabe, Tetsuo Nagano, Tadahiko Mashino. Reingold, J. P. (2016) Discovery and Development of Kelch-like ECH-Associated Protein 1. Raja. 2016. Spelman, L. Park. CrossRef 81 Benedikt Kretzschmar, Hannah Pellkofer, Martin S. Miclea, V. (2016) Disease-modifying therapies and infectious risks in multiple sclerosis. The role of oxidative stress in the pathogenesis of multiple sclerosis: the need for effective antioxidant therapy. Scannevin, Scott S. (2016) Cost-effectiveness of delayed-release dimethyl fumarate for the treatment of relapsing forms of multiple sclerosis in the United States. CrossRef 38 Emer Fogarty, Susanne Schmitz, Niall Tubridy, Cathal Walsh, Michael Barry. Ma, L. (2016) A review of the ethics of the use of placebo in clinical trials for relapsing-remitting multiple sclerosis therapeutics. Rating neurologic impairment in multiple sclerosis: an Expanded Disability Status Scale (EDSS). Fumarates promote cytoprotection of central nervous system cells against oxidative stress via the Nrf2 pathway. CrossRef 114 Nele Claes, Judith Fraussen, Piet Stinissen, Raymond Hupperts, Veerle Somers. CrossRef 47 A. Mekhael, T. , diarrhea, nausea, upper abdominal pain, abdominal pain, and vomiting), proteinuria, and pruritus ( Table 3 ). Cohen, Daniel Ontaneda. J. Banwell. Kildebeck, Ram Narayan, Katherine Treadaway, Elliot M. (2016) A Framework of Care in Multiple Sclerosis, Part 1. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. Burke, H. W. (2016) Management of Multiple Sclerosis in the Breastfeeding Mother. CrossRef 49 Yuxue Zhang, Yongfan Hou, Chunchun Liu, Yinlong Li, Weiwei Guo, Jiu-Lin Wu, Daqian Xu, Xue You, Yi Pan, Yan Chen. Similarly, in the CONFIRM trial, there were fewer multiple sclerosis lesions on MRI scans in patients who received BG-12 than in those who received placebo. Abdalla, P. 36 in the placebo group, representing relative reductions with BG-12 of 53% and 48%, respectively (P Supplementary Appendix ). Patients were randomly assigned to receive oral BG-12 at a dose of 240 mg twice daily, BG-12 at a dose of 240 mg three times daily, or placebo. Constantinescu. Further exploration of the mechanism of action of BG-12 may help to guide future clinical studies. The percentage of patients who switched to an approved therapy for multiple sclerosis was low (13% in the placebo group, 6% in the twice-daily BG-12 group, and 5% in the thrice-daily BG-12 group). Cohen,. (2015) B Cells Are Multifunctional Players in Multiple Sclerosis Pathogenesis: Insights from Therapeutic Interventions. Frohman. CrossRef 33 Haiyan Peng, Huo Li, Adam Sheehy, Patrick Cullen, Norm Allaire, Robert H. (2015) The budget impact of introducing delayed-release dimethyl fumarate for treatment of relapse-remitting multiple sclerosis in Canada. Kotra, J. B. 2016. CrossRef 79 R. Al-Shammri. Fumarates improve psoriasis and multiple sclerosis by inducing type II dendritic cells. Wingerchuk. Efficacy Relapses The proportion of patients who had at least one relapse of multiple sclerosis by 2 years was significantly reduced with each BG-12 regimen as compared with placebo. M. (2016) Disseminated zoster with paresis in a multiple sclerosis patient treated with dimethyl fumarate. Zaro, K. (2016) Early Relapsing Multiple Sclerosis. CrossRef 82 T. Thussu, K. Wu, Q. All scans were evaluated in a blinded manner at a central reading facility (NeuroRx Research). CrossRef 88 Naila Makhani, Teri Schreiner. Pucci, S. (2016) Balancing Early Aggression Against Risk of Progression in Multiple Sclerosis. Epstein, Jun Zeng, Junlian Gu, Guang Liang, Maiying Kong, Xiangmei Chen, Lining Miao, Lu Cai. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. A. Mao-Draayer. Patients were 18 to 56 years of age and had received a diagnosis of multiple sclerosis between 0 and 32 years before study entry. Schulte-Mecklenbeck, S. Evaluation of serial electrocardiograms showed no clinically relevant changes in the corrected QT interval or any other electrocardiographic variable. 9 weeks and was similar among the three groups. CrossRef 32 Harald Hegen, Michael Auer, Florian Deisenhammer. Khan, A. 05, and assuming an estimated dropout rate of 23%, we estimated that we would need to enroll 337 patients in each group for the study to have 90% power to detect the 30% reduction in the percentage of patients with a relapse in each BG-12 group as compared with the placebo group. Blewett, J. Alexander, P. CrossRef 85 Suneetha A. C. Article Activity 379 articles have cited this article Article Oral BG-12 (dimethyl fumarate) is being investigated for the treatment of multiple sclerosis. The effects of BG-12 were apparent at 12 weeks and were sustained for the duration of the study. Marantz. The overall incidence of malignant neoplasms was less than 1% in all the groups ( Table 3, and Table S8 in the Supplementary Appendix ). M. (2016) Disease activity return after natalizumab cessation in multiple sclerosis. Wang, C. Butzkueven, S. Chronicity of Immune Abnormality in Atopic Dermatitis: Interacting Surface Between Environment and Immune System. CrossRef 90 B. A. Kansal, Sujata Sarda. (2016) Some recent advances in multiple sclerosis. Collins, B. Jones. The primary end point was the proportion of patients who had a relapse by 2 years. CrossRef 80 Josephine Mauskopf, Monica Fay, Ravi Iyer, Sujata Sarda, Terrie Livingston. PRISMS-4: long-term efficacy of interferon-beta-1a in relapsing MS. (2016) Renal dysfunction in patients taking fumaric acid esters - a retrospective cross-sectional study. (2016) Control of Oxidative Stress and Inflammation in Sickle Cell Disease with the Nrf2 Activator Dimethyl Fumarate. CrossRef 48 Yao Zhu, Ya-Jie Zhang, Wei-Wei Liu, Ai-Wu Shi, Ning Gu. No such elevations of aminotransferase levels were concurrent with increases in bilirubin that were more than two times the upper limit of the normal range. The State of the Art of Redox Therapeutic Actions in Neurodegenerative Diseases. Granella, E. P. CrossRef 12 Laurent Peyrin-Biroulet, Corinne Gower-Rousseau. Ko, Peri Barr, Rahul Sasane. These data are also consistent with results from preclinical studies, in which BG-12 has been shown to have beneficial effects in animal models through direct neuroprotective and immunomodulatory mechanisms. Cravatt. We observed an increased incidence of elevations in liver aminotransferase levels, primarily between months 1 and 6. Solomon, James L. (2017) Sodium butyrate activates NRF2 to ameliorate diabetic nephropathy possibly via inhibition of HDAC. The mean duration of participation in the study was 83. (2016) The Keap1-Nrf2-ARE Pathway As a Potential Preventive and Therapeutic Target: An Update. Jones. CrossRef 40 Roland Martin, Mireia Sospedra, Maria Rosito, Britta Engelhardt. (2016) Use of Disease-Modifying Therapies in Pediatric MS. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. Sheikh, Vissia Viglietta. Hartung, R. (2016) Novel Agents for Relapsing Forms of Multiple Sclerosis. The rate of discontinuation of the study drug was similar in the three groups (35% in the placebo group and 31% in each of the BG-12 groups), as was the rate of withdrawal from the study (22% in the placebo group and 23% in each of the BG-12 groups) (Table S3 and Fig. Skoko, Nobunao Wakabayashi, Susan Aja, Masayuki Yamamoto, Thomas W. Marrie, A. W. Journal of the European Academy of Dermatology and Venereology. (2016) Dimethyl fumarate treatment of relapsing-remitting multiple sclerosis influences B-cell subsets. There remains a considerable unmet need for safe treatment options that are more effective than current first-line agents and are appropriate for a wide spectrum of patients with multiple sclerosis. (2016) Oral Dimethyl Fumarate in Children With Multiple Sclerosis: A Dual-Center Study. Miller, M. Weber. Results The estimated proportion of patients who had a relapse was significantly lower in the two BG-12 groups than in the placebo group (27% with BG-12 twice daily and 26% with BG-12 thrice daily vs. Dowling, S. CrossRef 31 Lucia Romano Bernardini, Chiara Zecca, Valentina Torri Clerici, Claudio Gobbi, Renato Mantegazza, Silvia Rossi. Geneva: ICH, June 10, 1996 ( ). (2016) Dimethyl Fumarate: A Review in Relapsing-Remitting MS. Press release of Biogen Idec, Weston, MA, October 26, 2011 ( ). CrossRef 54 Zaidoon Al-Jaderi, Azzam A. (2017) Toll-like receptor signalling as a cannabinoid target in Multiple Sclerosis. A total of 540 patients were included in the subgroup of patients who underwent MRI. Weiner. There were no cases of renal failure classified by the investigator as serious adverse events. CrossRef 5 Wenpeng Dong, Ye Jia, Xiuxia Liu, Huan Zhang, Tie Li, Wenlin Huang, Xudong Chen, Fuchun Wang, Weixia Sun, Hao Wu. CrossRef 115 Greg Thaera, Dean M. ICH harmonized tripartite guideline — guideline for good clinical practice: E6(R1). CrossRef 22 S. (2016) Currently approved and emerging oral therapies in multiple sclerosis: An update for the ophthalmologist. H. CrossRef 92 S. Among patients who switched to alternative medications, data collected after the switch were excluded from the safety analyses. CrossRef 113 L. CrossRef 91 Alexander Winkelmann, Micha Loebermann, Emil C. Giliberti, Andrea Nico, Maria Pia Rossi, Maria Filomena Caiaffa, Luigi Macchia. Marti, Reiner Kunze. Maghazachi. Therapeutic Approaches to MS and Other Neurodegenerative Diseases. Gastroenteritis and gastritis (both of which occurred in The incidence of infections was similar across the study groups (65% in the placebo group, 64% in the twice-daily BG-12 group, and 68% in the thrice-daily BG-12 group). Tariq Bhatti.
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