News Biogen Idec’s Study Reviews Positive Results Over Five Years of Tecfidera RRMS Treatment Biogen Idec’s Study Reviews Positive Results Over Five Years of Tecfidera RRMS Treatment by Patricia Silva, PhD | September 15, 2014 Share this article: Share article via email Copy article link Biogen Idec presented theĀ five-year results from its ENDORSE phase 3 extension study of TecfideraĀ (dimethyl fumarate), which revealed that the treatment is able to provide strong and sustained efficacy to patients with relapsing-remitting multiple sclerosis (RRMS), at last week’sĀ ACTRIMS-ECTRIMSĀ summit. Not only did the safety profile of Tecfidera in the ENDORSE study remain consistentĀ with no new or worsening safety signals, but also newly diagnosed patientsĀ with multiple sclerosis (MS) revealedĀ robust long-term effects on MS relapse rates, disability progression, and MRI measures in these patients, as they were treated with Tecfidera duringĀ the parent studies DEFINE and CONFIRM. āTECFIDERA continues to provide patients with effective oral treatment for MS that is supported by a growing body of data reinforcing its benefits and favorable safety profile,ā stated the group senior vice president and chief medical officer at Biogen Idec,Ā Alfred Sandrock, M.D., Ph.D. āThese new ENDORSE results provide further insight into the positive impact of using TECFIDERA early in the course of MS and for long-term treatment of this chronic disease.ā ENDORSE is described by the company as a dose-blind extension study with a global scope, which was designed to determine long-term measures of both safety and efficacy as an oral treatment for RRMS, which is given in doses of 240 mg two or three times daily. The 5-year results of the long-range study revealed thatĀ patients who continued to take TECFIDERA BID treatment for RRMS experienced a sustained clinical efficacy on minimizing relapse and disability progression, according to the data measured by annualized relapse rate (ARR) and 24-week Expanded Disability Status Scale (EDSS), similar to what was observed after two years in DEFINE and CONFIRM. Patients in study also notedĀ a low frequency of brain lesions over five years, which was measured by new or enlarging T2-hyperintense lesions, new non-enhancing T1-hypointense lesions and gadolinium-enhanced [Gd+] lesions. The long-term efficacy of Tecfidera in newly diagnosed patients was assessed on ENDORSE, andĀ defined as those diagnosed within one year prior to enrolling in DEFINE or CONFIRM and either disease modifying treatment-naĆÆve or previously treated with corticosteroids alone. [adrotate group=”4″] āAs shown in the ENDORSE study, Tecfidera provides consistent outcomes across a broad range of relapsing-remitting MS patients, including those who are newly diagnosed, highlighting its utility in the range of patients we see in practice,ā explained Ralf Gold, M.D., professor and chair of the Department of Neurology at St. Josef-Hospital, Ruhr-University in Bochum, Germany. āThe long-term efficacy of Tecfidera in reducing key measures of disease activity and its favorable safety profile help support its role as an important therapeutic option for people living with MS.ā Biogen Idec also analyzed long-term effects of Tecfidera on the emerging measure of No Evidence of Disease Activity (NEDA) over a five-year period. Patients were examined annually in order to evaluate if there wereĀ no relapses, no 24-week confirmed disability progression, no Gd+ lesions, and no new or enlarging T2-hyperintense lesions. The results revealed that the number ofĀ patients achieving NEDA annually was maintained in patients who continued Tecfidera treatment, and was improved in patients who switched from placebo to Tecfidera, in the ENDORSE study. Biogen Idec’s drug was introduced this year in Europe, after the UKāsĀ National Institute for Health and Care ExcellenceĀ (NICE) gave a positive final appraisal determination to the use of theĀ TecfideraĀ in adults, having turned back on their preliminary negative recommendation. TheĀ oral therapy, which was already approved in the United States, is now also an alternative for patients suffering from the disease in England and Wales. Print This Page About the Author Patricia Silva, PhD PatrĆcia holds a PhD in medical microbiology and infectious diseases from the Leiden University Medical Center, Netherlands, and completed a postdoctoral research fellowship at the Instituto de Medicina Molecular, Lisbon, Portugal. Her work in academia was mainly focused on molecular biology and the genetic traits of infectious agents such as viruses and parasites. PatrĆcia earned several travel awards to present her work at international scientific meetings. She is a published author of several peer-reviewed science articles. Tags 2014 ACTRIMS-ECTRIMS Meeting, Biogen Idec, RRMS, Tecfidera
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