Use of follow-on fingolimod for multiple sclerosis: Analysis of effectiveness and patient reported outcomes in a real-world clinical setting

• Published in: Multiple sclerosis and related disorders Vol. 77; p. 104880
• Main Authors: Altunan, Bengü, Ünal, Aysun, Efendi, Hüsnü, Köseoğlu, Mesrure, Terzi, Murat, Kotan, Dilcan, Tamam, Yusuf, Boz, Cavit, Güler, Sibel, Turan, Ömer Faruk, Altunrende, Burcu, Balcı, Fatma Belgin, Turgut, Nilda, Akçalı, Aylin, Yildirim, Kadriye Ağan, Günal, Dilek İnce, Sunter, Gulin, Bingöl, Ayhan
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.09.2023
• Subjects: Adherence; Efficacy; Follow-on drug; Generic fingolimod; Neurology; Real-world data; Safety; Satisfaction; Adherence; Generic fingolimod; Real-world data; Satisfaction; Efficacy; Safety; Follow-on drug
• ISSN: 2211-0348; 2211-0356; 2211-0356
• DOI: 10.1016/j.msard.2023.104880

•The cost of DMTs used in people with MS has steadily increased over the last few decades.•In order to reduce the cost, follow-on drugs have been put on the markets.•Phase III studies and in-laboratory quality assessments are the most reliable methods, but studies with real-life data are also valuable in the absence of adequate conditions.•This study evaluated the efficacy, safety and patient compliance of one of the follow-on fingolimods used in our country with real-life data.•Human health is always a priority. This study is a step to remove the doubts that exist in the literature and in real life about follow-on fingolimod risk management. Follow-on disease modifying therapies (FO-DMTs) do not always require Phase III studies. There are concerns that cheaper FO-DMTs are only used to reduce healthcare costs. However, the well-being of people with MS (pwMS) should be a priority. We aimed to evaluate the efficacy, safety and treatment satisfaction of one of the FO- Fingolimod (FTY) used in Turkey with the approval of Turkish Ministry of Health. PwMS under FTY were recruited from 13 centers and real-world data and answers of satisfaction and adherence statements of pwMS on FTY treatment were analyzed. Data of 239 pwMS were obtained. The duration of FTY treatment was 2.5 ± 0.8 (1–4) years in pwMS who were included in the study and whose treatment continued for at least one year. Significant decreases in annual relapse rate (p < 0.001), Expanded Disability Status Scale (p < 0.001) and neuroimaging findings (p < 0.001) were observed. While 64% of the patients were satisfied and 71.5% were found to adherent with this FO-FTY. This multicenter retrospective study found that the efficacy, safety and treatment adherence of a prescribed FO-FTY were consistent with the results of real-world studies. Studies including real-world data may provide guidance to address issues related to FO-FTY use.