Sėdžius Paulius, Musneckienė Dalia
Department of Neurology, Lithuanian University of Health Sciences, A. Mickevičiaus Str. 9, LT-44307 Kaunas, Lithuania.
Medicina (Kaunas). 2025 Apr 21;61(4):762. doi: 10.3390/medicina61040762.
Selecting appropriate disease-modifying drugs (DMDs) is crucial for optimizing treatment and slowing disease progression in multiple sclerosis (MS). Real-world studies assess drug efficacy and usage in routine clinical practice. Therefore, the goal of this study was to determine the efficacy and safety of oral drug therapy in patients with relapsing-remitting multiple sclerosis and the particularities of adherence to the therapy. A retrospective and prospective study was conducted at the Neurology Clinic of the Kaunas Clinics of the Lithuanian University of Health Sciences. The medical records of patients with relapsing-remitting multiple sclerosis (RRMS) were reviewed. The retrospective study included 286 patients, and the prospective study included 175 patients. The study population included 131 patients on teriflunomide (TFN), 53 on dimethyl fumarate (DMF), 37 on fingolimod (FTY), and 65 on cladribine (CLAD). The overall absolute reduction in the ARR over 4 years of treatment was higher in the second-line (FTY and CLAD) group (-2.00) compared with the first-line (-0.99) group (TFN and DMF). The total EDSS scores of patients who received FTY and CLAD were higher in the second (3.09, = 0.024), third (3.94, = 0.015), and fourth (3.6, = 0.002) years of treatment, compared with the patients of first-line therapy. MRI revealed that the number of contrast-enhancing and new lesions was lower among patients taking second-line drugs in the second year (4.7% and 18.6%, respectively). The worst adherence to the drug therapy due to forgetfulness was observed in the DMF group (30.8%). Lymphopenia was less frequent in the TFN group (93.1%) and more frequent in the FTY group (86.5%) ( < 0.001). Over four years, second-line patients had greater ARR reduction, fewer MRI lesions, and higher EDSS from year two. DMF showed the lowest adherence, mainly due to patient forgetfulness, while lymphopenia occurred most frequently with FTY.
选择合适的疾病修正药物(DMDs)对于优化多发性硬化症(MS)的治疗和减缓疾病进展至关重要。真实世界研究评估药物在常规临床实践中的疗效和使用情况。因此,本研究的目的是确定口服药物治疗复发缓解型多发性硬化症患者的疗效和安全性以及坚持治疗的特殊性。在立陶宛卫生科学大学考纳斯诊所的神经科进行了一项回顾性和前瞻性研究。对复发缓解型多发性硬化症(RRMS)患者的病历进行了审查。回顾性研究包括286名患者,前瞻性研究包括175名患者。研究人群包括131名服用特立氟胺(TFN)的患者、53名服用富马酸二甲酯(DMF)的患者、37名服用芬戈莫德(FTY)的患者和65名服用克拉屈滨(CLAD)的患者。在4年的治疗中,二线治疗组(FTY和CLAD)的年复发率(ARR)总体绝对降低值(-2.00)高于一线治疗组(TFN和DMF)(-0.99)。接受FTY和CLAD治疗的患者在治疗的第二年(3.09,P = 0.024)、第三年(3.94,P = 0.015)和第四年(3.6,P = 0.002)的扩展残疾状态量表(EDSS)总分高于一线治疗的患者。磁共振成像(MRI)显示,服用二线药物的患者在第二年的强化病灶和新病灶数量较少(分别为4.7%和18.6%)。DMF组因遗忘导致的药物治疗依从性最差(30.8%)。TFN组淋巴细胞减少的发生率较低(93.1%),而FTY组较高(86.5%)(P < 0.001)。在四年时间里,二线治疗的患者ARR降低幅度更大,MRI病灶更少,从第二年起EDSS更高。DMF的依从性最低,主要是由于患者遗忘,而淋巴细胞减少在FTY治疗中最为常见。