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Öğe A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients FINE Trial(Aves, 2019) Akman Demir, Gulsen; Turkoglu, Recai; Saip, Sabahattin; Yuceyar, Nur; Efendi, Husnu; Turan, Omer Faruk; Kocer, BelginIntroduction: To assess satisfaction and quality of life in patients with relapsing-remitting multiple sclerosis (RRMS) who were receiving fingolimod (0.5 mg/day) for 12 months as a second-line treatment after switching from injectable agents. Methods: Patients aged 18-65 years with RRMS who fulfilled the eligibility criteria were enrolled from 16 centers throughout Turkey. Treatment Satisfaction Questionnaire for Medication and 36-item Short-Form Health Survey were completed at baseline and four visits to assess patient satisfaction and quality of life. Results: Forty-two patients (62% male; mean age: 35.7 +/- 9.4 years) were eligible for inclusion. Patient satisfaction scores at the end of the study 44.7 +/- 9.9) were significantly higher than those at baseline [32.0 +/- 9.9; (p<0.001)]. The only significant increase in the quality of life survey was in the emotional aspect (p=0.019). There were 124 adverse events and none of the five serious adverse events noted was considered drugrelated. Conclusion: Large-scale comparative studies performed with disease specific quality of life instruments will allow more information on this issue.Öğe Comparative analysis of fingolimod versus teriflunomide in relapsing-remitting multiple sclerosis(Elsevier Sci Ltd, 2019) Boz, Cavit; Terzi, Murat; Ozer, Bilge; Turkoglu, Recai; Karabudak, Rana; Efendi, Husnu; Ozakbas, SerkanBackground: Fingolimod and teriflunomide are commonly used in the treatment of relapsing-remitting multiple sclerosis (RRMS). These have not been compared in controlled trials, but only in observational studies, with inconclusive results. Comparison of their effect on relapse and disability in a real-world setting is therefore needed. Objectives: the objective of this study was to compare the efficacy of fingolimod and teriflunomide in reducing disease activity in RRMS. Methods: This multicenter, retrospective observational study was carried out with prospectively collected data from 15 centers. All consecutive RRMS patients treated with teriflunomide or fingolimod were included. Data for relapses, Expanded Disability Status Scale (EDSS) scores and brain magnetic resonance imaging (MRI) scans were collected. Patients were matched using propensity scores. Annualized relapse rates (ARR), disability accumulation, percentage of patients with active MRI and treatment discontinuation over a median 2.5-year follow-up period were compared. Results: Propensity score matching retained 349 out of 1388 patients in the fingolimod group and 349 out 678 in the teriflunomide group for final analyses. Mean ARR decreased markedly from baseline after 1 and 2 years of treatment in both the fingolimod (0.58-0.17 after 1 year and 0.11 after 2 years, p < 0.001) and teriflunomide (0.56-0.29 after 1 year and 0.31 after 2 years, p < 0.001) groups. Mean ARR was lower in fingolimod-treated patients than in those treated with teriflunomide at years 1 (p = 0.02) and 2 (p = 0.004). Compared to teriflunomide, the fingolimod group exhibited a higher percentage of relapse-free patients and a lower percentage of MRI-active patients after 2.5-year follow-up. Disability worsening was similar between the two groups. Patients were less likely to discontinue fingolimod than teriflunomide (p < 0.001). Conclusion: Fingolimod was associated with a better relapse control and lower discontinuation rate than teriflunomide. the two oral therapies exhibited similar effects on disability outcomes.Öğe The comparative effectiveness of fingolimod, natalizumab, and ocrelizumab in relapsing-remitting multiple sclerosis(Springer-Verlag Italia Srl, 2023) Boz, Cavit; Ozakbas, Serkan; Terzi, Murat; Karabudak, Rana; Sevim, Serhan; Turkoglu, Recai; Soysal, AysunBackgroundFingolimod, natalizumab, and ocrelizumab are commonly used in the second-line treatment of relapsing-remitting multiple sclerosis (RRMS). However, these have only been compared in observational studies, not in controlled trials, with limited and inconclusive results being reported. A comparison of their effect on relapse and disability in a real-world setting is therefore needed.ObjectivesThe objective of this study was to compare the efficacy of fingolimod, natalizumab, and ocrelizumab in reducing disease activity in RRMS.MethodsThis multicenter, retrospective observational study was carried out with prospectively collected data from 16 centers. All consecutive RRMS patients treated with fingolimod, natalizumab, and ocrelizumab were included. Data for relapses, Expanded Disability Status Scale (EDSS) scores, and brain magnetic resonance imaging (MRI) scans were collected. Patients were matched using propensity scores. Annualized relapse rates (ARR), time to first relapse, and disability accumulation were compared.ResultsPropensity score matching retained 736 patients in the fingolimod versus 370 in the natalizumab groups, 762 in the fingolimod versus 434 in the ocrelizumab groups, and 310 in the natalizumab versus 310 in the ocrelizumab groups for final analyses. Mean ARR decreased markedly from baseline after treatment in all three treatment groups. Mean on-treatment ARR was lower in natalizumab-treated patients (0.09, 95% confidence interval (CI), 0.07-0.12) than in those treated with fingolimod (0.17, 0.15-0.19, p<0.001), ocrelizumab (0.08, 0.06-0.11), and fingolimod (0.14, 0.12-0.16, p=0.001). No significant difference was observed in mean on-treatment ARR between patients treated with natalizumab (0.08, 0.06-0.11) and ocrelizumab (0.09, 0.07-0.12, p=0.54). Compared to fingolimod, the natalizumab and ocrelizumab groups exhibited a higher percentage of relapse-free patients and a lower percentage of MRI-active patients at year 1. No significance differences in disability accumulation were determined between the therapies.ConclusionNatalizumab and ocrelizumab exhibited similar effects on relapse control, and both were associated with better relapse control than fingolimod. The effects of the three therapies on disability outcomes were similar.