Chinea Angel, Amezcua Lilyana, Vargas Wendy, Okai Annette, Williams Mitzi J, Su Ray, Parks Becky, Mendoza Jason P, Lewin James B, Jones Cynthia C
From the San Juan Multiple Sclerosis Center, Guaynabo, Puerto Rico.
Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Neurol Ther. 2020 Dec;9(2):495-504. doi: 10.1007/s40120-020-00192-6. Epub 2020 May 29.
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.
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.
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.
Relapse rates remained low in Hispanic/Latino patients, consistent with non-Hispanic/non-Latino patients. The safety profile of DMF in Hispanic/Latino patients was consistent with safety findings from the non-Hispanic/non-Latino ESTEEM population, demonstrating the real-world treatment benefit of DMF in the Hispanic/Latino patient cohort.
据报道，与非西班牙裔/非拉丁裔人群相比，患有多发性硬化症（MS）的西班牙裔/拉丁裔患者疾病严重程度更高。地理位置和基因在西班牙裔/拉丁裔亚人群体中观察到的差异中起作用。我们评估了富马酸二甲酯（DMF）对西班牙裔/拉丁裔MS患者疾病活动的实际安全性和有效性。
ESTEEM是一项正在进行的为期5年的多国前瞻性研究，评估DMF对MS患者的长期安全性和有效性。这项中期分析纳入了全球394个地点在常规实践中新开具DMF处方的患者。
总体上，分析了4986名非西班牙裔/非拉丁裔患者和98名西班牙裔/拉丁裔患者；中位（范围）随访时间为18（2 - 37）个月。DMF起始前12个月与起始后36个月的未调整年化复发率（ARR）分别为：非西班牙裔/非拉丁裔患者，0.82（95%CI 0.80 - 0.84）对0.10（95%CI 0.09 - 0.10），ARR降低88%（P < 0.0001）；西班牙裔/拉丁裔患者，0.80（95%CI 0.65 - 1.00）对0.09（95%CI 0.06 - 0.14），ARR降低89%（P < 0.0001）。共有28名（29%）西班牙裔/拉丁裔患者报告了导致治疗中断的不良事件；胃肠道（GI）疾病（n = 10，10%）最为常见，与非西班牙裔/非拉丁裔人群一致（8%）。大多数患者第一年淋巴细胞计数中位数下降约24%（非西班牙裔/非拉丁裔患者下降36%），然后保持稳定且高于正常下限。
西班牙裔/拉丁裔患者的复发率仍然较低，与非西班牙裔/非拉丁裔患者一致。DMF在西班牙裔/拉丁裔患者中的安全性与非西班牙裔/非拉丁裔ESTEEM人群的安全性发现一致，证明了DMF在西班牙裔/拉丁裔患者队列中的实际治疗益处。
