
浏览全部资源
扫码关注微信
重庆医科大学附属第一医院神经内科,重庆 400016
杨小林,Email:1245624162@qq.com,研究方向:神经免疫性疾病。
秦新月,Email:qinxinyuecy@sina.com。
收稿:2024-10-23,
修回:2025-01-02,
录用:2025-01-19,
纸质出版:2025-06-28
移动端阅览
杨小林,冯金洲,秦新月.多发性硬化疾病修正治疗初治模式探索的真实世界研究[J].重庆医科大学学报,2025,50(6):791-798.
Yang Xiaolin,Feng Jinzhou,Qin Xinyue.Exploration of the initial patterns of disease-modifying treatment in patients with multiple sclerosis:a real-world study[J].Journal of Chongqing Medical University,2025,50(6):791-798.
杨小林,冯金洲,秦新月.多发性硬化疾病修正治疗初治模式探索的真实世界研究[J].重庆医科大学学报,2025,50(6):791-798. DOI: 10.13406/j.cnki.cyxb.003807.
Yang Xiaolin,Feng Jinzhou,Qin Xinyue.Exploration of the initial patterns of disease-modifying treatment in patients with multiple sclerosis:a real-world study[J].Journal of Chongqing Medical University,2025,50(6):791-798. DOI: 10.13406/j.cnki.cyxb.003807.
目的
2
探索中国重庆地区部分多发性硬化(multiple sclerosis,MS)患者的疾病修正治疗(disease-modifying treatment,DMT)初治模式。
方法
2
收集2018年11月至2024年1月在重庆医科大学附属第一医院就诊且首次启动DMT(特立氟胺、富马酸二甲酯、鞘氨醇-1磷酸受体调节剂、奥法妥木单抗)的复发缓解型MS(relapsing-remitting MS,RRMS)患者的临床资料和影像学数据,分析患者的DMT初治处方分布、持续使用率、安全性、治疗后疾病活动情况及影响疾病活动的危险因素。
结果
2
共纳入RRMS患者138例,以特立氟胺、富马酸二甲酯、鞘氨醇-1-磷酸(Sphingosine-1-Phosphate,S1P)受体调节剂、奥法妥木单抗作为初治处方的比例分别为46.4%、20.3%、21.7%和11.6%。在随访期内,72.5%的患者坚持初治处方,23.2%的患者转换处方,主要升级为奥法妥木单抗。4类DMT使用期间均未发生药物相关的死亡事件、住院事件,但S1P受体调节剂的任何不良事件发生率最高,可达43.3%。对115例患者治疗后的疾病活动性分析提示,47.0%的患者存在疾病活动。首次起病后未完全恢复(
OR
=3.645,95%CI=1.321~10.060,
P
=0.013)、吸烟(
OR
=10.052,95%CI=1.025~98.556,
P
=0.048)是RRMS患者疾病活动的独立危险因素。
结论
2
中国重庆地区RRMS患者的初治DMT处方在过去5年内以低中效药物为主,仍有较大比例患者在启动DMT后存在疾病活动,转向早期高效的DMT初治模式或许能更有效降低MS患者的疾病活动,延缓残疾进展。
Objective
2
To explore the initiation patterns of disease-modifying treatment(DMT) in patients with multiple sclerosis (MS) in Chongqing,China.
Methods
2
The clinical and imaging data of patients with relapsing-remitting MS(RRMS) who commenced DMT(teriflunomide,dimethyl fumarate,sphingosine-1-phosphate receptor modulators,or ofatumumab) for the first time at the Department of Neurology,The First Affiliated Hospital of Chongqing Medical University from November 2018 to January 2024 were obtained. The analysis focused on the distribution,persistence rate,and safety of initial DMT prescriptions,post-treatment disease activity,and risk factors affecting disease activity.
Results
2
A total of 138 patients with RRMS were included. The distribution of initial DMT prescriptions was as follows:teriflunomide(46.4%),dimethyl fumarate(20.3%),sphingosine-1-phosphate receptor modulators(21.7%),and ofatumumab(11.6%). Throughout the follow-up period,72.5% of patients complied with their initial prescription,whereas 23.2% of patients altered their treatments,predominantly transitioning to ofatumumab. No drug-related death or hospitalization was documented during the use of the four DMT prescriptions. However,sphingosine-1-phosphate receptor modulators exhibited the highest incidence of adverse events(43.3%). An analysis of post-treatment disease activity in 115 patients indicated that 47.0% of patients displayed disease activity. Independent risk factors for disease activity comprised incomplete recovery after the initial onset of MS (odds ratio[
OR
]=3.645,95%CI=1.321-10.06,
P
=0.013) and smoking(
OR
=10.052,95%CI=1.025-98.556,
P
=0.048).
Conclusion
2
In the last five years,the majority of initial DMT prescriptions for patients with RRMS in Chongqing,China,were low- to moderate-efficacy drugs. A considerable percentage of patients exhibited disease activity despite commencing DMT. Prompt commencement of high-efficacy DMT may be more effective in diminishing disease activity and postponing disability progression in patients with MS.
Jakimovski D , Bittner S , Zivadinov R , et al . Multiple sclerosis [J ] . Lancet , 2024 , 403 ( 10422 ): 183 - 202 .
Vasileiou ES , Fitzgerald KC . Multiple sclerosis pathogenesis and updates in targeted therapeutic approaches [J ] . Curr Allergy Asthma Rep , 2023 , 23 ( 9 ): 481 - 496 .
Tian DC , Zhang C , Yuan M , et al . Incidence of multiple sclerosis in China:a nationwide hospital-based study [J ] . Lancet Reg Health West Pac , 2020 , 1 : 100010 .
Kuhlmann T , Moccia M , Coetzee T , et al . Multiple sclerosis progression:time for a new mechanism-driven framework [J ] . Lancet Neurol , 2023 , 22 ( 1 ): 78 - 88 .
The Lancet Neurology . Multiple sclerosis under the spotlight [J ] . Lancet Neurol , 2021 , 20 ( 7 ): 497 .
Gold R , Arnold DL , Bar-Or A , et al . Long-term safety and efficacy of dimethyl fumarate for up to 13 years in patients with relapsing-remitting multiple sclerosis:Final ENDORSE study results [J ] . Mult Scler , 2022 , 28 ( 5 ): 801 - 816 .
Hauser SL , Zielman R , Das Gupta A , et al . Efficacy and safety of four-year ofatumumab treatment in relapsing multiple sclerosis:The ALITHIOS open-label extension [J ] . Mult Scler , 2023 , 29 ( 11/12 ): 1452 - 1464 .
Selmaj K , Cree BAC , Barnett M , et al . Multiple sclerosis:time for early treatment with high-efficacy drugs [J ] . J Neurol , 2024 , 271 ( 1 ): 105 - 115 .
Konen FF , Möhn N , Witte T , et al . Treatment of autoimmunity:The impact of disease-modifying therapies in multiple sclerosis and comorbid autoimmune disorders [J ] . Autoimmun Rev , 2023 , 22 ( 5 ): 103312 .
O'Connor P , Comi G , Freedman MS , et al . Long-term safety and efficacy of teriflunomide:Nine-year follow-up of the randomized TEMSO study [J ] . Neurology , 2016 , 86 ( 10 ): 920 - 930 .
McGinley MP , Cohen JA . Sphingosine 1-phosphate receptor modulators in multiple sclerosis and other conditions [J ] . Lancet , 2021 , 398 ( 10306 ): 1184 - 1194 .
Montes Diaz G , Hupperts R , Fraussen J , et al . Dimethyl fumarate treatment in multiple sclerosis:Recent advances in clinical and immunological studies [J ] . Autoimmun Rev , 2018 , 17 ( 12 ): 1240 - 1250 .
Kang C , Blair HA . Ofatumumab:a review in relapsing forms of multiple sclerosis [J ] . Drugs , 2022 , 82 ( 1 ): 55 - 62 .
Ontaneda D , Tallantyre E , Kalincik T , et al . Early highly effective versus escalation treatment approaches in relapsing multiple sclerosis [J ] . Lancet Neurol , 2019 , 18 ( 10 ): 973 - 980 .
Stahmann A , Craig E , Ellenberger D , et al . Disease-modifying therapy initiation patterns in multiple sclerosis in three large MS populations [J ] . Ther Adv Neurol Disord , 2024 , 17 : 17562864241233044 .
Foong YC , Merlo D , Gresle M , et al . Comparing ocrelizumab to interferon/glatiramer acetate in people with multiple sclerosis over age 60 [J ] . J Neurol Neurosurg Psychiatry , 2024 , 95 ( 8 ): 767 - 774 .
Oreja-Guevara C , Martínez-Yélamos S , Eichau S , et al . Beyond lines of treatment:embracing early high-efficacy disease-modifying treatments for multiple sclerosis management [J ] . Ther Adv Neurol Disord , 2024 , 17 : 17562864241284372 .
Thompson AJ , Banwell BL , Barkhof F , et al . Diagnosis of multiple sclerosis:2017 revisions of the McDonald criteria [J ] . Lancet Neurol , 2018 , 17 ( 2 ): 162 - 173 .
谭红梅 , 全超 . “ 基于中国已获批疾病修正治疗,探索复发型多发性硬化的治疗策略”解读 [J ] . 中国临床神经科学 , 2024 , 32 ( 5 ): 545 - 550 .
Tan HM , Quan C . Interpretation of “Treatment Algorithms of Relapsing Multiple Sclerosis:An Exploration Based on the Available Disease-modifying Therapies in China ”[J ] . Chin J Clin Neurosci , 2024 , 32 ( 5 ): 545 - 550 .
Prosperini L , Annovazzi P , Boffa L , et al . No evidence of disease activity(NEDA-3) and disability improvement after alemtuzumab treatment for multiple sclerosis:a 36-month real-world study [J ] . J Neurol , 2018 , 265 ( 12 ): 2851 - 2860 .
Olsson T , Barcellos LF , Alfredsson L . Interactions between genetic,lifestyle and environmental risk factors for multiple sclerosis [J ] . Nat Rev Neurol , 2017 , 13 ( 1 ): 25 - 36 .
Rosso M , Chitnis T . Association between cigarette smoking and multiple sclerosis:a review [J ] . JAMA Neurol , 2020 , 77 ( 2 ): 245 - 253 .
Van Wijmeersch B , Hartung HP , Vermersch P , et al . Using personalized prognosis in the treatment of relapsing multiple sclerosis [J ] . Front Immunol , 2022 , 13 : 991291 .
Guo J , Wu J , Wang L , et al . Treatment algorithms of relapsing multiple sclerosis:an exploration based on the available disease-modifying therapies in China [J ] . Ther Adv Neurol Disord , 2024 , 17 : 17562864241239117 .
中华医学会神经病学分会神经免疫学组 . 多发性硬化诊断和治疗中国指南(2023版) [J ] . 中华神经科杂志 , 2024 , 57 ( 1 ): 10 - 23 .
Chinese Society of Neurology , Neuroimmunology Group . Chinese guidelines for diagnosis and treatment of multiple sclerosis(2023) [J ] . Chinese Journal of Neurology , 2024 , 57 ( 1 ): 10 - 23 .
谭红梅 , 全 超 . 多发性硬化疾病修正治疗进展 [J ] . 重庆医科大学学报 , 2024 , 49 ( 5 ): 588 - 592 .
Tan HM , Quan C . Advances in disease-modifying therapy for multiple sclerosis [J ] . J Chongqing Med Univ , 2024 , 49 ( 5 ): 588 - 592 .
Papukchieva S , Stratil AS , Kahn M , et al . Shifting from the treat-to-target to the early highly effective treatment approach in patients with multiple sclerosis-real-world evidence from Germany [J ] . Ther Adv Neurol Disord , 2024 , 17 : 17562864241237857 .
Papukchieva S , Kim HD , Stratil AS , et al . Real-world evidence from Germany and the United States:Treatment initiation on low-efficacy versus high-efficacy therapies in patients with multiple sclerosis [J ] . Mult Scler Relat Disord , 2024 , 88 : 105751 .
Spelman T , Magyari M , Piehl F , et al . Treatment escalation vs immediate initiation of highly effective treatment for patients with relapsing-remitting multiple sclerosis [J ] . JAMA Neurol , 2021 , 78 ( 10 ): 1197 - 1204 .
Kappos L , Bar-Or A , Cree BAC , et al . Siponimod versus placebo in secondary progressive multiple sclerosis(EXPAND):a double-blind,randomised,phase 3 study [J ] . Lancet , 2018 , 391 ( 10127 ): 1263 - 1273 .
Chitnis T , Arnold DL , Banwell B , et al . Trial of fingolimod versus interferon beta-1a in pediatric multiple sclerosis [J ] . N Engl J Med , 2018 , 379 ( 11 ): 1017 - 1027 .
Comi G , Kappos L , Selmaj KW , et al . Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis(SUNBEAM):a multicentre,randomised,minimum 12-month,phase 3 trial [J ] . Lancet Neurol , 2019 , 18 ( 11 ): 1009 - 1020 .
Berger T , Brochet B , Brambilla L , et al . Effectiveness of delayed-release dimethyl fumarate on patient-reported outcomes and clinical measures in patients with relapsing-remitting multiple sclerosis in a real-world clinical setting:PROTEC [J ] . Mult Scler J Exp Transl Clin , 2019 , 5 ( 4 ): 2055217319887191 .
Paolicelli D , Manni A , Iaffaldano A , et al . Efficacy and safety of oral therapies for relapsing-remitting multiple sclerosis [J ] . CNS Drugs , 2020 , 34 ( 1 ): 65 - 92 .
Yang J , Hamade M , Wu Q , et al . Current and future biomarkers in multiple sclerosis [J ] . Int J Mol Sci , 2022 , 23 ( 11 ): 5877 .
Calabrese M , Preziosa P , Scalfari A , et al . Determinants and biomarkers of progression independent of relapses in multiple sclerosis [J ] . Ann Neurol , 2024 , 96 ( 1 ): 1 - 20 .
Wattjes MP , Ciccarelli O , Reich DS , et al . 2021 MAGNIMS-CMSC-NAIMS consensus recommendations on the use of MRI in patients with multiple sclerosis [J ] . Lancet Neurol , 2021 , 20 ( 8 ): 653 - 670 .
Gavoille A , Rollot F , Casey R , et al . Acute clinical events identified as relapses with stable magnetic resonance imaging in multiple sclerosis [J ] . JAMA Neurol , 2024 , 81 ( 8 ): 814 - 823 .
Bsteh G , Aicher ML , Walde JF , et al . Association of disease-modifying treatment with outcome in patients with relapsing multiple sclerosis and isolated MRI activity [J ] . Neurology , 2024 , 103 ( 6 ): e209752 .
Lublin FD , Häring DA , Ganjgahi H , et al . How patients with multiple sclerosis acquire disability [J ] . Brain , 2022 , 145 ( 9 ): 3147 - 3161 .
Wu J , Olsson T , Hillert J , et al . Influence of oral tobacco versus smoking on multiple sclerosis disease activity and progression [J ] . J Neurol Neurosurg Psychiatry , 2023 , 94 ( 8 ): 589 - 596 .
Lebrun-Frenay C , Kantarci O , Siva A , et al . Radiologically isolated syndrome:10-Year risk estimate of a clinical event [J ] . Ann Neurol , 2020 , 88 ( 2 ): 407 - 417 .
0
浏览量
11
下载量
0
CSCD
关联资源
相关文章
相关作者
相关机构
京公网安备11010802024621