Real-World Safety and Effectiveness of Dimethyl Fumarate in Black or African American Patients with Multiple Sclerosis: 3-Year Results from ESTEEM

Autor:	Becky Parks, Darin T. Okuda, James B. Lewin, Jason P. Mendoza, Stanley Cohan, Lilyana Amezcua, Mitzi J. Williams, Ray Su, Cynthia C. Jones, Annette Okai
Rok vydání:	2020
Předmět:	medicine.medical_specialty Population Gastroenterology Dimethyl fumarate Multiple sclerosis 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine medicine 030212 general & internal medicine RC346-429 education Adverse effect Prospective cohort study Original Research education.field_of_study business.industry medicine.disease Interim analysis Discontinuation Clinical trial Safety and effectiveness Neurology chemistry Neurology. Diseases of the nervous system Neurology (clinical) business 030217 neurology & neurosurgery
Zdroj:	Neurology and Therapy, Vol 9, Iss 2, Pp 483-493 (2020) Neurology and Therapy
ISSN:	2193-6536 2193-8253
DOI:	10.1007/s40120-020-00193-5
Popis:	Introduction Black or African American (black/AA) patients with multiple sclerosis (MS) are reported to exhibit greater disease severity compared with non-black or non-AA patients. Whether differences exist in response to MS disease-modifying therapies remains uncertain, as MS clinical trials have included low numbers of non-white patients. We evaluated real-world safety and effectiveness of dimethyl fumarate (DMF) on MS disease activity in black/AA patients. Methods ESTEEM is an ongoing, 5-year, multinational, prospective study evaluating long-term safety and effectiveness of DMF in patients with MS. This interim analysis included patients newly prescribed DMF in routine practice at 394 sites globally. Results Overall, 4897 non-black/non-AA and 187 black/AA patients were analyzed; median (range) follow-up 18 (2–37) months. Unadjusted annualized relapse rates (ARRs) for 12 months before DMF initiation versus 36 months post DMF initiation, respectively, were: non-black/non-AA patients, 0.83 (95% CI 0.80–0.85) versus 0.10 (95% CI 0.09–0.10), 88% lower ARR (P
Databáze:	OpenAIRE
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