Biogen Idec presented the five-year results from its ENDORSE phase 3 extension study of Tecfidera (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’s ACTRIMS-ECTRIMS summit.
Not only did the safety profile of Tecfidera in the ENDORSE study remain consistent with no new or worsening safety signals, but also newly diagnosed patients with multiple sclerosis (MS) revealed robust long-term effects on MS relapse rates, disability progression, and MRI measures in these patients, as they were treated with Tecfidera during the parent studies DEFINE and CONFIRM.
“TECFIDERA 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,” stated the group senior vice president and chief medical officer at Biogen Idec, Alfred Sandrock, M.D., Ph.D. “These 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.”
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 that 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 noted 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, and defined as those diagnosed within one year prior to enrolling in DEFINE or CONFIRM and either disease modifying treatment-naïve or previously treated with corticosteroids alone.
“As 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,” explained Ralf Gold, M.D., professor and chair of the Department of Neurology at St. Josef-Hospital, Ruhr-University in Bochum, Germany. “The 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.”
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 were 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 of 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 UK’s National Institute for Health and Care Excellence (NICE) gave a positive final appraisal determination to the use of the Tecfidera in adults, having turned back on their preliminary negative recommendation. The 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.