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 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, 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.
Aim: Using matching-adjusted indirect comparison, we compared efficacy outcomes in patients with relapsing-remitting multiple sclerosis treated with delayed-release dimethyl fumarate (DMF) or glatiramer acetate (GA). Materials & methods: An indirect comparison of DMF (patient-level data) and GA (aggregate data) was conducted, with average baseline characteristics of DMF patients weighted to match those for GA patients. Direct comparison of DMF and GA was conducted in CONFIRM. Final results pooled the indirect and direct comparisons using meta-analysis. Results: After matching, baseline characteristics were balanced between DMF and GA patients. Compared with GA, efficacy was significantly in favor of DMF as measured by annualized relapse rate (rate ratio: 0.76; 95% CI: 0.57-1.00; p = 0.0474) and 12-week confirmed disability progression (risk ratio: 0.59; 95% CI: 0.46-0.76; p < 0.0001). Conclusion: DMF demonstrated superior clinical efficacy versus GA.
Introduction: Compared with the non-Hispanic/non-Latino population, Hispanic/Latino patients with multiple sclerosis (MS) are reported to exhibit greater disease severity. Geographical location and genetics play a role in differences observed across Hispanic/Latino subpopulations. We evaluated real-world safety and effectiveness of dimethyl fumarate (DMF) on MS disease activity in Hispanic/Latino 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, 4986 non-Hispanic/non-Latino and 98 Hispanic/Latino patients were analyzed; median (range) follow-up was 18 (2-37) months. Unadjusted annualized relapse rates (ARRs) for 12 months before DMF initiation versus 36 months post DMF initiation, respectively, were: non-Hispanic/non-Latino patients, 0.82 (95% CI 0.80-0.84) versus 0.10 (95% CI 0.09-0.10), 88% lower ARR (P \ 0.0001); Hispanic/Latino patients, 0.80 (95% CI 0.65-1.00) versus 0.09 (95% CI 0.06-0.14), 89% lower ARR (P \ 0.0001). In total, 28 (29%) Hispanic/Latino patients reported adverse events leading to treatment discontinuation; gastrointestinal (GI) disorders (n = 10, 10%) were the most common, consistent with the non-Hispanic/non-Latino population (8%). Median lymphocyte counts decreased by approximately 24% in the first year (vs 36% decrease in non-Hispanic/non-Latino patients) then remained stable and above the lower limit of normal in most patients. Digital features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12205952. B. Parks was an employee of Biogen at the time the research was conducted.
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