A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial

Yıl: 2019 Cilt: 56 Sayı: 4 Sayfa Aralığı: 253 - 257 Metin Dili: İngilizce DOI: 10.5152/npa.2017.20515 İndeks Tarihi: 03-09-2020

A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial

Öz:
Introduction: To assess satisfaction and quality of life in patients with relapsing–remittingmultiplesclerosis(RRMS)whowerereceivingfingolimod (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 drug-related.Conclusion: Large-scale comparative studies performed with disease specific quality of life instruments will allow more information on this issue
Anahtar Kelime:

Fingolimod Tedavisinin Yineleyici MS Hastalarındaki Etkilerini Değerlendiren Açık Etiketli, 12 Ay Süreli Pilot Çalışma - Fine Çalışma Grubu

Öz:
Amaç: Prospektif, çok merkezli bu çalışmanın amacı, enjekte edilebilir ajanlardan sonra ikinci basamak ilaç olarak 12 ay süreyle 0,5 mg/gün dozunda fingolimod kullanan yineleyici multipl skleroz hastalarının memnuniyetlerinin ve yaşam kalitelerinin değerlendirilmesidir.Yöntem: Çalışmaya Türkiye genelinde 16 merkezden, 18-65 yaş arasında, dahiletmekriterlerinikarşılayanyineleyicimultiplsklerozhastalarıkatılmışlardır.Hastalara;memnuniyetlerininveyaşamkalitelerinindeğerlendirmesi amacı ile başlangıç ve takip eden diğer dört vizitte İlaç Memnuniyet Anketi ve Kısa Form-36 Sağlık Durumu Anketi uygulanmıştır.Bulgular: Yaş ortalamaları 35,7±9,4 olan ve %62’sini erkek hastaların oluşturduğu toplamda 42 hasta çalışmaya dahil edilmiştir. Çalışmanın sonunda hasta memnuniyeti skorları (44,7±9,9) çalışma başlangıcına (32,0±9,9) kıyasla anlamlı olarak yüksek bulunmuştur (p<0,001). Yaşam kalitesi anketi sonuçlarında ise yalnızca emosyenel fonksiyon skorunda bir artış görülmüştür (p=0,019). Çalışma süresince 124 advers olay kaydedilirken, rapor edilen 5 ciddi advers olaydan hiçbiri ilaçla ilişkili olarak değerlendirilmemiştir.Sonuç: Hastalığa özgü yaşam kalitesi değerlendirme yöntemleri ile gerçekleştirilecek olan geniş ölçekli karşılaştırma çalışmaları, bu konuda daha çok bilgi alınmasına olanak sağlayacaktır.
Anahtar Kelime:

Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık
  • 1. Tullman MJ. Overview of the epidemiology, diagnosis, and disease progression associated with multiple sclerosis. Am J Manag Care 2013;19:S15–20.
  • 2. Koch-Henriksen N, Sørensen PS. The changing demographic pattern of multiple sclerosis epidemiology. Lancet Neurol 2010;9:520–532. [CrossRef ]
  • 3. Cutter G, Yadavalli R, Marrie RA, Tyry T, Campagnolo D, Bullock B, Vollmer T. Changes in the Sex Ratio over Time in Multiple Sclerosis. 29th Annual Meeting American Academy of Neurology; Abstract No:04.068, 2007.
  • 4. Minagar A. Current and future therapies for multiple sclerosis. Scientifica (Cairo) 2013;2013:249101. [CrossRef ]
  • 5. Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O’Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol 2011;69:292–302. [CrossRef ]
  • 6. Diebold M, Derfuss T. Oral therapies for relapsing- remitting multiple sclerosis. Swiss Arch Neurol 2015;166:170–175.
  • 7. Tanasescu R, Ionete C, Chou IJ, Constantinescu CS. Advances in the treatment of relapsing-remitting multiple sclerosis. Biomed J 2014;37:41–9. [CrossRef ]
  • 8. Calkwood J, Cree B, Crayton H, Kantor D, Steingo B, Barbato L, Hashmonay R, Agashivala N, McCague K, Tenenbaum N, Edwards K. Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial. BMC Neurol 2014:26;14:220. [CrossRef ]
  • 9. Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M, Rowland CR. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes 2004;2:12. [CrossRef ]
  • 10. Bandari DS, Vollmer TL, Khatri BO, Tyry T. Assessing quality of life in patients with multiple sclerosis. Int J MS Care 2010;12:34–41. [CrossRef ]
  • 11. Cohen JA, Barkhof F, Comi G, Izquierdo G, Khatri B, Montalban X, Pelletier J, Eckert B, Häring DA, Francis G. Fingolimod versus intramuscular interferon in patient subgroups from TRANSFORMS. J Neurol 2013;260:2023–2032. [CrossRef ]
  • 12. Calabresi PA, Radue EW, Goodin D, Jeffery D, Rammohan KW, Reder AT, Vollmer T, Agius MA, Kappos L, Stites T, Li B, Cappiello L, von Rosenstiel P, Lublin FD. Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol 2014;13:545–556. [CrossRef ]
  • 13. Kappos L, Radue EW, O’Connor P, Polman C, Hohlfeld R, Calabresi P, Selmaj K, Agoropoulou C, Leyk M, Zhang-Auberson L, Burtin P; FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010;362:387–401. [CrossRef ]
  • 14. Cohen JA, Barkhof F, Comi G, Hartung HP, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, Tiel-Wilck K, de Vera A, Jin J, Stites T, Wu S, Aradhye S, Kappos L; TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010;3625:402–415. [CrossRef ]
  • 15. Cohen JA, Khatri B, Barkhof F, Comi G, Hartung HP, Montalban X, Pelletier J, Stites T, Ritter S, von Rosenstiel P, Tomic D, Kappos L; TRANSFORMS (TRial Assessing injectable interferoN vS. FTY720 Oral in RRMS) Study Group. Long-term (up to 4 5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomised TRANSFORMS study. J Neurol Neurosurg Psychiatry 2016;87:468–475. [CrossRef ]
  • 16. Kappos L, O’Connor P, Radue EW, Polman C, Hohlfeld R, Selmaj K, Ritter S, Schlosshauer R, von Rosenstiel P, Zhang-Auberson L, Francis G. Long-term effects of fingolimod in multiple sclerosis: the randomized FREEDOMS extension trial. Neurology 2015;84:1582–1591. [CrossRef ]
  • 17. Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla AA, Karkare SU, McGuiness CB, Korn JR. Relapse rates in patients with multiple sclerosis switching from interferon to fingolimod or glatiramer acetate: a US claims database study. PLoS ONE 2014;9:e88472. [CrossRef ]
  • 18. He A, Spelman T, Jokubaitis V, Havrdova E, Horakova D, Trojano M, Lugaresi A, Izquierdo G, Grammond P, Duquette P, Girard M, Pucci E, Iuliano G, Alroughani R, Oreja-Guevara C, Fernandez-Bolaños R, Grand’Maison F, Sola P, Spitaleri D, Granella F, Terzi M, Lechner-Scott J, Van Pesch V, Hupperts R, Sánchez- Menoyo JL, Hodgkinson S, Rozsa C, Verheul F, Butzkueven H, Kalincik T; MSBase Study Group. Comparison of switch to fingolimod or interferon beta / glatiramer acetate in active multiple sclerosis. JAMA Neurol 2015;72:405–413. [CrossRef ]
  • 19. Duerr HP, Alsop J, Bergvall N, Cornelissen C, Vormfelde SV, Ziemssen T. Effectiveness of fingolimod compared with interferons and glatiramer acetate for the treatment of multiple sclerosis: a matched comparison of treatments from the PANGAEA and PEARL studies (P3.253). Neurology 2015;84 (14 Supplement). https://n.neurology.org/content/84/14_Supplement/P3.253
  • 20. Bergvall N, Petrilla AA, Karkare SU, Lahoz R, Agashivala N, Pradhan A, Capkun G, Makin C, McGuiness CB, Korn JR. Persistence with and adherence to fingolimod compared with other disease-modifying therapies for the treatment of multiple sclerosis: a retrospective US claims database analysis. J Med Econ 2014;17:696–707. [CrossRef ]
  • 21. Lapierre Y, Selchen D, Devonshire V, Schecter R. Switching from injectable therapy leads to high continuation rate on fingolimod. Presented at the American Academy of Neurology annual meeting, 26 April-3 May 2014, Philadelpha PA, USA; abstract P7.221.
  • 22. Comi G, Gold R, Dahlke F, Sinha A, von Rosenstiel P, Tomic D, Kappos L. Relapses in patients treated with fingolimod after previous exposure to natalizumab. Mult Scler J 2015;21:786–790. [CrossRef ]
  • 23. Lublin F, Miller DH, Freedman MS, Cree BA, Wolinsky JS, Weiner H, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BM, Merschhemke M, Li B, Putzki N, Liu FC, Häring DA, Kappos L; INFORMS study investigators. Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet 2016;387:1075–1084. [CrossRef ]
  • 24. Kappos L, Cohen J, Collins W, de Vera A, Auberson LZ, Ritter S, von Rosenstiel P, Francis G. Fingolimod in relapsing multiple sclerosis: An integrated analysis of safety findings. Mult Scler Relat Disord 2014;3:494–504. [CrossRef ]
  • 25. Gajofatto A, Turatti M, Monaco S, Benedetti MD. Clinical efficacy, safety, and tolerability of fingolimod for the treatment of relapsing-remitting multiple sclerosis. Drug Health Patient Saf 2015;7:157–167. [CrossRef ]
  • 26. Gold R, Comi G, Palace J, Siever A, Gottschalk R, Bijarnia M, von Rosenstiel P, Tomic D, Kappos L; FIRST Study Investigators. Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study. J Neurol 2014;261:267–276. [CrossRef ]
  • 27. Kes VB, Cengic L, Cesarik M, Tomas AJ, Zavoreo I, Matovina LZ, Coric L, Drnasin S, Demarin V. Quality of life in patients with multiple sclerosis. Acta Clin Croat 2013;52:107–111.
  • 28. Fox E, Edwards K, Burch G, Wynn DR, LaGanke C, Crayton H, Hunter SF, Huffman C, Kim E, Pestreich L, McCague K, Barbato L; EPOC study investigators. Outcomes of switching directly to oral fingolimod from injectable therapies:results of the randomized, open–label, multicenter, Evaluate Patient OutComes (EPOC) study in relapsing multiple sclerosis. Mult Scler Relat Disord 2014;3:607–619. [CrossRef ]
APA DEMİR G, Türkoğlu R, SAİP S, YUCEYAR N, Efendi H, turan ö, AĞAN K, TERZİ M, Boz C, Tuncer a, Kocer B, KASAP M, Caliskan Z, GROUP F (2019). A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial. , 253 - 257. 10.5152/npa.2017.20515
Chicago DEMİR Gülşen AKMAN,Türkoğlu Recai,SAİP Sabahattin,YUCEYAR NUR,Efendi Hüsnü,turan ömer faruk,AĞAN Kadriye,TERZİ Murat,Boz Cavit,Tuncer aslı,Kocer Belgin,KASAP Mithat,Caliskan Zeynep,GROUP FINE Study A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial. (2019): 253 - 257. 10.5152/npa.2017.20515
MLA DEMİR Gülşen AKMAN,Türkoğlu Recai,SAİP Sabahattin,YUCEYAR NUR,Efendi Hüsnü,turan ömer faruk,AĞAN Kadriye,TERZİ Murat,Boz Cavit,Tuncer aslı,Kocer Belgin,KASAP Mithat,Caliskan Zeynep,GROUP FINE Study A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial. , 2019, ss.253 - 257. 10.5152/npa.2017.20515
AMA DEMİR G,Türkoğlu R,SAİP S,YUCEYAR N,Efendi H,turan ö,AĞAN K,TERZİ M,Boz C,Tuncer a,Kocer B,KASAP M,Caliskan Z,GROUP F A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial. . 2019; 253 - 257. 10.5152/npa.2017.20515
Vancouver DEMİR G,Türkoğlu R,SAİP S,YUCEYAR N,Efendi H,turan ö,AĞAN K,TERZİ M,Boz C,Tuncer a,Kocer B,KASAP M,Caliskan Z,GROUP F A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial. . 2019; 253 - 257. 10.5152/npa.2017.20515
IEEE DEMİR G,Türkoğlu R,SAİP S,YUCEYAR N,Efendi H,turan ö,AĞAN K,TERZİ M,Boz C,Tuncer a,Kocer B,KASAP M,Caliskan Z,GROUP F "A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial." , ss.253 - 257, 2019. 10.5152/npa.2017.20515
ISNAD DEMİR, Gülşen AKMAN vd. "A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial". (2019), 253-257. https://doi.org/10.5152/npa.2017.20515
APA DEMİR G, Türkoğlu R, SAİP S, YUCEYAR N, Efendi H, turan ö, AĞAN K, TERZİ M, Boz C, Tuncer a, Kocer B, KASAP M, Caliskan Z, GROUP F (2019). A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial. Nöropsikiyatri Arşivi, 56(4), 253 - 257. 10.5152/npa.2017.20515
Chicago DEMİR Gülşen AKMAN,Türkoğlu Recai,SAİP Sabahattin,YUCEYAR NUR,Efendi Hüsnü,turan ömer faruk,AĞAN Kadriye,TERZİ Murat,Boz Cavit,Tuncer aslı,Kocer Belgin,KASAP Mithat,Caliskan Zeynep,GROUP FINE Study A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial. Nöropsikiyatri Arşivi 56, no.4 (2019): 253 - 257. 10.5152/npa.2017.20515
MLA DEMİR Gülşen AKMAN,Türkoğlu Recai,SAİP Sabahattin,YUCEYAR NUR,Efendi Hüsnü,turan ömer faruk,AĞAN Kadriye,TERZİ Murat,Boz Cavit,Tuncer aslı,Kocer Belgin,KASAP Mithat,Caliskan Zeynep,GROUP FINE Study A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial. Nöropsikiyatri Arşivi, vol.56, no.4, 2019, ss.253 - 257. 10.5152/npa.2017.20515
AMA DEMİR G,Türkoğlu R,SAİP S,YUCEYAR N,Efendi H,turan ö,AĞAN K,TERZİ M,Boz C,Tuncer a,Kocer B,KASAP M,Caliskan Z,GROUP F A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial. Nöropsikiyatri Arşivi. 2019; 56(4): 253 - 257. 10.5152/npa.2017.20515
Vancouver DEMİR G,Türkoğlu R,SAİP S,YUCEYAR N,Efendi H,turan ö,AĞAN K,TERZİ M,Boz C,Tuncer a,Kocer B,KASAP M,Caliskan Z,GROUP F A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial. Nöropsikiyatri Arşivi. 2019; 56(4): 253 - 257. 10.5152/npa.2017.20515
IEEE DEMİR G,Türkoğlu R,SAİP S,YUCEYAR N,Efendi H,turan ö,AĞAN K,TERZİ M,Boz C,Tuncer a,Kocer B,KASAP M,Caliskan Z,GROUP F "A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial." Nöropsikiyatri Arşivi, 56, ss.253 - 257, 2019. 10.5152/npa.2017.20515
ISNAD DEMİR, Gülşen AKMAN vd. "A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial". Nöropsikiyatri Arşivi 56/4 (2019), 253-257. https://doi.org/10.5152/npa.2017.20515