Long-term effects of delayed-release dimethyl fumarate in multiple sclerosis: Interim analysis of ENDORSE, a randomized extension study
| العنوان: | Long-term effects of delayed-release dimethyl fumarate in multiple sclerosis: Interim analysis of ENDORSE, a randomized extension study |
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| المؤلفون: | Robert J. Fox, Michael Hutchinson, Carlo Pozzilli, Eva Havrdova, K. Selmaj, Ralf Gold, David G. MacManus, Theodore Phillips, James Potts, Minhua Yang, Tarek A. Yousry, Mark Novas, Douglas L. Arnold, Nuwan Kurukulasuriya, Marianne T. Sweetser, Ludwig Kappos, Ray Zhang, Amit Bar-Or, David Miller |
| المصدر: | Multiple Sclerosis (Houndmills, Basingstoke, England) |
| بيانات النشر: | SAGE Publications, 2016. |
| سنة النشر: | 2016 |
| مصطلحات موضوعية: | Oncology, Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Time Factors, Dimethyl Fumarate, Treatment outcome, DEFINE, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, medicine, Humans, 030212 general & internal medicine, ENDORSE, Glatiramer acetate, Expanded Disability Status Scale, Dimethyl fumarate, business.industry, Relapsing–remitting multiple sclerosis, Extension study, Multiple sclerosis, Glatiramer Acetate, medicine.disease, Interim analysis, Magnetic Resonance Imaging, Surgery, delayed-release dimethyl fumarate (DMF), Relapsing-remitting multiple sclerosis, Neurology, Neurology (clinical), Treatment Outcome, chemistry, Delayed-release dimethyl fumarate (DMF), Female, business, Original Research Papers, 030217 neurology & neurosurgery, Immunosuppressive Agents, medicine.drug |
| الوصف: | Background: Delayed-release dimethyl fumarate (DMF) demonstrated strong efficacy and a favorable benefit–risk profile for patients with relapsing–remitting multiple sclerosis (RRMS) in phase 3 DEFINE/CONFIRM studies. ENDORSE is an ongoing long-term extension of DEFINE/CONFIRM. Objective: We report efficacy and safety results of a 5-year interim analysis of ENDORSE (2 years DEFINE/CONFIRM; minimum 3 years ENDORSE). Methods: In ENDORSE, patients randomized to DMF 240 mg twice (BID) or thrice daily (TID) in DEFINE/CONFIRM continued this dosage, and those initially randomized to placebo (PBO) or glatiramer acetate (GA) were re-randomized to DMF 240 mg BID or TID. Results: For patients continuing DMF BID (BID/BID), annualized relapse rates were 0.202, 0.163, 0.139, 0.143, and 0.138 (years 1–5, respectively) and 63%, 73%, and 88% were free of new or enlarging T2 hyperintense lesions, new T1 hypointense lesions, and gadolinium-enhanced lesions, respectively, at year 5. Adverse events (AEs; serious adverse events (SAEs)) were reported in 91% (22%; BID/BID), 95% (24%; PBO/BID), and 88% (16%; GA/BID) of the patients. One case of progressive multifocal leukoencephalopathy was reported in the setting of severe, prolonged lymphopenia. Conclusion: Treatment with DMF was associated with continuously low clinical and magnetic resonance imaging (MRI) disease activity in patients with RRMS. These interim data demonstrate a sustained treatment benefit and an acceptable safety profile with DMF. |
| اللغة: | English |
| تدمد: | 1477-0970 1352-4585 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c1f78ef34d45e60a75761dd3357f9937Test http://europepmc.org/articles/PMC5418934Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....c1f78ef34d45e60a75761dd3357f9937 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14770970 13524585 |
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