Sabet Haneen, Zanaty Mohamed Ahmed, Arafa Abdelfattah, El-Moslemani Mohamed, Olama Shereen Mohamed, Saleh Mahmoud G A, Abbas Abdallah, Obeidat Ahmed Z
Faculty of Medicine, South Valley University, Qena, Egypt.
Faculty of Medicine, Al-Azhar University, Damietta, Egypt.
Neurol Sci. 2025 Apr 14. doi: 10.1007/s10072-025-08140-8.
To evaluate the safety and efficacy of Diroximel Fumarate (DRF) in patients with different relapsing forms of MS (RMS) through systematic review and meta-analysis.
A systematic review and meta-analysis adhering to PRISMA guidelines was conducted. Scopus, PubMed, and Cochrane CENTRAL databases were searched until December 6, 2024, for clinical trials and observational studies on DRF in RMS. Eligibility criteria included studies evaluating DRF's safety or efficacy, excluding case reports and non-clinical outcomes. The risk of bias was assessed using the Newcastle-Ottawa Scale and ROBINS-I tools. Statistical analyses were performed using OpenMetaAnalyst, focusing on pooled mean differences and incidence rates with 95% confidence intervals.
Seven studies with 3,075 participants were included. The overall persistence rate was 75.6% (95% CI: 63.5%, 87.7%). The discontinuation rate due to safety concerns was 6.1% (95% CI: 4.1%, 8.1%). Lymphocyte count decreased significantly by -355.02 cells/µL (95% CI: -636.71, -73.32). Mild adverse events (AEs) occurred in 33% (95% CI: 18.6%, 47.4%), moderate in 30% (95% CI: -9.9%, 69.9%), and severe in 5% (95% CI: -3.8%, 13.7%). Gastrointestinal (GI) AEs were observed in 17.4% (95% CI: 6%, 28.8%), flushing in 18.5% (95% CI: 5.7%, 31.3%), and lymphopenia in 24.3% (95% CI: 10.2%, 38.4%). The relapse rate was 7.1% (95% CI: -4.8%, 19%).
DRF demonstrates efficacy in reducing relapse rates and offers an improved safety profile compared to its predecessor, Dimethyl Fumarate (DMF), particularly in GI tolerability. However, lymphopenia requires monitoring. Further research is recommended to evaluate long-term safety and efficacy in diverse populations.
通过系统评价和荟萃分析，评估富马酸二罗昔麦尔（DRF）在不同复发形式的多发性硬化症（RMS）患者中的安全性和有效性。
进行了一项遵循PRISMA指南的系统评价和荟萃分析。检索了Scopus、PubMed和Cochrane CENTRAL数据库，直至2024年12月6日，以查找关于RMS中DRF的临床试验和观察性研究。纳入标准包括评估DRF安全性或有效性的研究，排除病例报告和非临床结果。使用纽卡斯尔-渥太华量表和ROBINS-I工具评估偏倚风险。使用OpenMetaAnalyst进行统计分析，重点关注合并平均差异和发病率以及95%置信区间。
纳入了7项研究，共3075名参与者。总体持续率为75.6%（95%置信区间：63.5%，87.7%）。因安全问题导致的停药率为6.1%（95%置信区间：4.1%，8.1%）。淋巴细胞计数显著下降-355.02个细胞/微升（95%置信区间：-636.71，-73.32）。轻度不良事件（AE）发生率为33%（95%置信区间：18.6%，47.4%），中度为30%（95%置信区间：-9.9%，69.9%），重度为5%（95%置信区间：-3.8%，13.7%）。观察到胃肠道（GI）AE的发生率为17.4%（95%置信区间：6%，28.8%），潮红为18.5%（95%置信区间：5.7%，31.3%），淋巴细胞减少为24.3%（95%置信区间：10.2%，38.4%）。复发率为7.1%（95%置信区间：-4.8%，19%）。
与前身富马酸二甲酯（DMF）相比，DRF在降低复发率方面显示出疗效，并且安全性有所改善，尤其是在胃肠道耐受性方面。然而，淋巴细胞减少需要监测。建议进一步研究以评估不同人群中的长期安全性和有效性。
