Biogen Reports TECFIDERA Data Confirms Strong, Sustained Efficacy in Newly-Diagnosed MS Patients

Biogen

unveiled new TECFIDERA® (dimethyl fumarate) research that reinforces its strong and sustained efficacy in newly diagnosed relapsing-remitting multiple sclerosis (RRMS) patients and further supports its long-term, well-characterized safety profile. These data were presented today at the 68th annual meeting of the American Academy of Neurology (AAN) in Vancouver, Canada. Data from a post-hoc analysis show that more than half of newly diagnosed patients treated with TECFIDERA were free from relapses and disability progression for six years, reinforcing that early, effective treatment with TECFIDERA improves long-term clinical outcomes. Additional real-world data from a claims database indicate that TECFIDERA is associated with significantly lower annualized relapse rates (ARR) relative to multiple disease modifying therapies (DMTs), including glatiramer acetate, interferon β and teriflunomide. These rates were similar between TECFIDERA and fingolimod. "The MS treatment landscape has expanded rapidly in recent years, giving physicians and patients options for various stages of disease. Beyond clinical findings, real-world data provide important insights into patients' experiences outside of clinical trials," said Kate Dawson, M.D., vice president, U.S. Medical. "These data show TECFIDERA consistently delivers strong and sustained efficacy in newly diagnosed patients both in a real-world and clinical setting, further supporting the value it offers patients and affirming the advantages of early treatment with TECFIDERA in decreasing clinical disease activity." Efficacy in Newly Diagnosed MS Patients New analyses from the Phase 3 DEFINE, CONFIRM and ENDORSE studies demonstrate long-term treatment with TECFIDERA continued to deliver strong and sustained benefits on relapse and disability measures in newly diagnosed patients (defined as those patients diagnosed with MS within one year prior to enrolling in DEFINE or CONFIRM and either treatment-naïve or previously treated with corticosteroids alone). Results show more than half of these patients remained free from relapses and disability progression over six years of study. Furthermore, a greater proportion of patients who initiated TECFIDERA treatment at the beginning of DEFINE and CONFIRM maintained these effects on relapses and disability progression compared to those who switched to TECFIDERA treatment in ENDORSE after taking placebo for two years in the parent studies (56.3% versus 50.6%). These data further support the benefits of early treatment with TECFIDERA to help slow the progression of MS. Understanding Therapeutic Effectiveness in Real-World Setting Additional data evaluate TECFIDERA relative to glatiramer acetate, interferon β, teriflunomide and fingolimod using U.S. health claims data, to provide a comprehensive understanding of therapeutic effectiveness in a real-world setting. In both newly diagnosed patients and those with previous DMT experience, TECFIDERA was associated with significantly lower ARR of MS relapse relative to glatiramer acetate, interferon β and teriflunomide. On the same measures, TECFIDERA and fingolimod were similar. After one year of follow-up, the differences in the unadjusted ARR rate from baseline across the DMT therapies were: TECFIDERA (-0.14; p<0.0001); interferon β (-0.03); glatiramer acetate (+0.03); teriflunomide (-0.04); fingolimod (-0.12; p=0.0016). Using TECFIDERA as the reference, after one year the adjusted incidence rate ratios of MS relapse were: 1.25 (95% confidence interval [CI]: 1.08-1.45) for interferon β; 1.28 (1.10-1.48) for glatiramer acetate; 1.28 (1.08-1.53) for teriflunomide; and 1.12 (0.94-1.33) for fingolimod. Additional Data Support Long-Term Well-Characterized Safety Profile In an effort to better understand the overall safety profile of TECFIDERA, data presented at AAN explore the treatment's effects on lymphocyte profiles. The data reinforce the importance of absolute lymphocyte counts (ALC) monitoring, in line with the guidance provided in the current U.S. label, and support the known, well-characterized long-term safety profile of TECFIDERA. Biogen is committed to patient safety and continues to further study these effects in an effort to optimize patient care. Data presentation details: Longer-Term Follow-Up of the Efficacy of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: Integrated Analysis of DEFINE, CONFIRM, and ENDORSE – Poster P3.033 – Monday, April 18, 8:30 a.m.-7 p.m. PT Comparative Effectiveness Research of Disease Modifying Therapies in Multiple Sclerosis – Findings from a Large Health Insurance Claims Database – Poster P3.116 – Monday, April 18, 8:30 a.m.-7 p.m. PT Characterization of Absolute Lymphocyte Count Profiles in MS Patients Treated with Delayed-Release Dimethyl Fumarate: Considerations for Patient Management – Poster P2.099 – Sunday, April 17, 8:30 a.m.-5:30 p.m. PT Lymphopenia in Patients with Multiple Sclerosis Treated with Delayed-release Dimethyl Fumarate: Analysis of Two United States Electronic Health Record Databases – Poster P2.098 – Sunday, April 17, 8:30 a.m.-5:30 p.m. PT