TY - JOUR
T1 - Real-World Safety and Effectiveness of Dimethyl Fumarate in Black or African American Patients with Multiple Sclerosis
T2 - 3-Year Results from ESTEEM
AU - Williams, Mitzi J.
AU - Amezcua, Lilyana
AU - Okai, Annette
AU - Okuda, Darin T.
AU - Cohan, Stanley
AU - Su, Ray
AU - Parks, Becky
AU - Mendoza, Jason P.
AU - Lewin, James B.
AU - Jones, Cynthia C.
N1 - Funding Information:
This study was sponsored by Biogen (Cambridge, MA, USA). Including the Rapid Service Fee.
Publisher Copyright:
© 2020, The Author(s).
PY - 2020/12/1
Y1 - 2020/12/1
N2 - 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 < 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, although lymphocyte decrease was less pronounced in black/AA patients.
AB - 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 < 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, although lymphocyte decrease was less pronounced in black/AA patients.
KW - Dimethyl fumarate
KW - Multiple sclerosis
KW - Safety and effectiveness
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U2 - 10.1007/s40120-020-00193-5
DO - 10.1007/s40120-020-00193-5
M3 - Article
C2 - 32472386
AN - SCOPUS:85085709902
SN - 2193-8253
VL - 9
SP - 483
EP - 493
JO - Neurology and Therapy
JF - Neurology and Therapy
IS - 2
ER -