Real-World Safety and Effectiveness of Dimethyl Fumarate in Black or African American Patients with Multiple Sclerosis:
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ORIGINAL RESEARCH
Real-World Safety and Effectiveness of Dimethyl Fumarate in Black or African American Patients with Multiple Sclerosis: 3-Year Results from ESTEEM Mitzi J. Williams . Lilyana Amezcua . Annette Okai . Darin T. Okuda . Stanley Cohan . Ray Su . Becky Parks . Jason P. Mendoza . James B. Lewin . Cynthia C. Jones
Received: April 2, 2020 Ó The Author(s) 2020
ABSTRACT 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 diseasemodifying therapies remains uncertain, as MS Digital features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12205916. B. Parks was an employee of Biogen at the time the research was conducted. M. J. Williams Joi Life Wellness MS Center, Atlanta, GA, USA L. Amezcua Keck School of Medicine, University of Southern California, Los Angeles, CA, USA A. Okai Multiple Sclerosis Treatment Center of Dallas, Dallas, TX, USA D. T. Okuda Neuroinnovation Program, UT Southwestern Medical Center, Dallas, TX, USA S. Cohan Providence Multiple Sclerosis Center, Providence Brain and Spine Institute, Portland, OR, USA R. Su B. Parks J. P. Mendoza J. B. Lewin C. C. Jones (&) Biogen, Cambridge, MA, USA e-mail: [email protected]
clinical trials have included low numbers of nonwhite 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 \ 0.0001); black/AA patients, 0.68 (95% CI 0.58–0.80) versus 0.07 (95% CI 0.05–0.10), 90% lower ARR (P \ 0.0001). In total, 35 (19%) black/AA patients reported adverse events leading to treatment discontinuation; gastrointestinal disorders were most common (7%), consistent with non-black/non-AA patients (8%). Median lymphocyte counts decreased by 22% in the first year (vs 36% in non-black/non-AA patients), then remained stable and above lower limit of normal in most patients. Conclusions: Relapse rates remained low in black/AA patients, consistent with non-black/ non-AA patients. The safety profile of DMF in black/AA patients was consistent with that in the non-black/non-AA ESTEEM population,
Neurol Ther
although lymphocyte decrease was less pronounced in black/AA patients. Keywords: Dimethyl fumarate; sclerosis; Safety and effectiveness
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