Batista S, Nunes C C, Cerqueira J J, Martins Silva Ana, Correia de Sá J, Ferreira J, Mendonça M T, Pinheiro J, Salgado V, Correia A S, Sequeira J, Costa A, Sousa L
Centro Hospitalar e Universitário de Coimbra, Praceta Prof. Mota Pinto, 3000-075, Coimbra, Portugal.
Hospital de Braga, Braga, Portugal.
Neurol Sci. 2021 May;42(5):1995-2003. doi: 10.1007/s10072-020-04726-6. Epub 2020 Sep 30.
Fingolimod, an oral sphingosine 1-phosphate receptor modulator, is approved by EMA for relapsing-remitting multiple sclerosis (RRMS).
To assess the effectiveness and safety of fingolimod in patients with RRMS in real-world clinical practice in Portugal.
Retrospective, multicentre, non-interventional study, reporting 3 years follow-up of data collected from October 2015 to July 2016. Sociodemographic data and previous treatments at baseline and data regarding disease evolution, including number of relapses, annualised relapse rates (ARR) and Expanded Disability Status Scale (EDSS), were collected.
Two-hundred and seventy-five participants were enrolled in the REALMS study. Results showed that the main reason to switch to fingolimod was failure of previous treatment (56.7%) and only 3.6% were naïve patients. In the total population, there was a significant decrease in ARR of 64.6% in the first year of treatment, 79.7% in the second year and 82.3% in the third year, compared with baseline. More than 67.0% of patients had no relapses during the 3 years after switching to fingolimod. EDSS remained stable throughout the study.
Therapy with fingolimod showed a sustained effectiveness and safety over the 3 years, particularly on patients switched from first-line drugs (BRACE). No new safety issues were reported.
芬戈莫德是一种口服的1-磷酸鞘氨醇受体调节剂，已获欧洲药品管理局（EMA）批准用于复发缓解型多发性硬化症（RRMS）。
评估芬戈莫德在葡萄牙真实临床实践中治疗RRMS患者的有效性和安全性。
一项回顾性、多中心、非干预性研究，报告了2015年10月至2016年7月收集的数据的3年随访情况。收集了社会人口统计学数据、基线时的既往治疗情况以及疾病进展数据，包括复发次数、年化复发率（ARR）和扩展残疾状态量表（EDSS）。
275名参与者纳入了REALMS研究。结果显示，改用芬戈莫德的主要原因是既往治疗失败（56.7%），仅有3.6%为初治患者。在总体人群中，与基线相比，治疗第一年ARR显著下降64.6%，第二年下降79.7%，第三年下降82.3%。超过67.0%的患者在改用芬戈莫德后的3年内无复发。在整个研究过程中，EDSS保持稳定。
芬戈莫德治疗在3年期间显示出持续的有效性和安全性，尤其是对从一线药物转换过来的患者（BRACE）。未报告新的安全问题。
