Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: Analyses of the EPOC trial

BMC Neurology

Volumn 14, Issue 1, 2014, Pages

  Calkwood, Jonathan ^a   Cree, Bruce ^b   Crayton, Heidi ^c   Kantor, Daniel ^d   Steingo, Brian ^e   Barbato, Luigi ^f   Hashmonay, Ron ^f   Agashivala, Neetu ^f   McCague, Kevin ^f   Tenenbaum, Nadia ^f   Edwards, Keith ^g  

^a Minneapolis Clinic of Neurology   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c MS Center of Greater Washington   (United States)

^d Neurologique ^*  (United States)

^e Fort Lauderdale MS Center   (United States)

^f NOVARTIS PHARMA AG   (Switzerland)

^g MS Center of Northeastern New York   (United States)

Author keywords

36 item Short Form Health Survey (SF 36); Beck Depression Inventory II (BDI II); Clinical Global Impressions of Improvement (CGI I); Fatigue Severity Scale (FSS); Fingolimod; FTY720; Multiple sclerosis; Treatment Satisfaction Questionnaire for Medication (TSQM)

Indexed keywords

BETA1A INTERFERON; FINGOLIMOD; GLATIRAMER; INTERFERON BETA SERINE; IMMUNOSUPPRESSIVE AGENT;

ADULT; AGED; ARTICLE; BECK DEPRESSION INVENTORY; CLINICAL GLOBAL IMPRESSION SCALE; DISEASE DURATION; DRUG SUBSTITUTION; EXPANDED DISABILITY STATUS SCALE; FATIGUE SEVERITY SCALE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTIPLE SCLEROSIS; NEUROLOGIC DISEASE ASSESSMENT; PATIENT PREFERENCE; PATIENT REPORTED OUTCOME INDICES FOR MULTIPLE SCLEROSIS; PATIENT SATISFACTION; RANDOMIZED CONTROLLED TRIAL; SHORT FORM 36; SIDE EFFECTS AND CONVENIENCE SUBSCALE; TREATMENT SATISFACTION QUESTIONNAIRE FOR MEDICATION GLOBAL SATISFACTION SCORE; CLINICAL TRIAL; CONTROLLED STUDY; INTRAMUSCULAR DRUG ADMINISTRATION; MIDDLE AGED; MULTICENTER STUDY; MULTIPLE SCLEROSIS, RELAPSING-REMITTING;

ADULT; AGED; FEMALE; FINGOLIMOD HYDROCHLORIDE; GLATIRAMER ACETATE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INJECTIONS, INTRAMUSCULAR; INTERFERON BETA-1A; INTERFERON BETA-1B; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS, RELAPSING-REMITTING;

EID: 84923928051     PISSN: None     EISSN: 14712377     Source Type: Journal    
DOI: 10.1186/s12883-014-0220-1     Document Type: Article

References (40)

1. Brinkmann V, Billich A, Baumruker T, Heining P, Schmouder R, Francis G, Aradhye S, Burtin P: Fingolimod (FTY720): discovery and development of an oral drug to treat multiple sclerosis. Nat Rev Drug Discov 2010, 9(11):883-897.
2. Sospedra M, Martin R: Immunology of multiple sclerosis. Annu Rev Immunol 2005, 23:683-747.
3. Weinshenker BG, Bass B, Rice GP, Noseworthy J, Carriere W, Baskerville J, Ebers GC: The natural history of multiple sclerosis: a geographically based study. 2. Predictive value of the early clinical course. Brain 1989, 112(Pt 6):1419-1428.
4. Janardhan V, Bakshi R: Quality of life in patients with multiple sclerosis: the impact of fatigue and depression. J Neurol Sci 2002, 205(1):51-58.
5. Brandes DW, Callender T, Lathi E, O'Leary S: A review of disease-modifying therapies for MS: maximizing adherence and minimizing adverse events. Curr Med Res Opin 2009, 25(1):77-92.
6. Treadaway K, Cutter G, Salter A, Lynch S, Simsarian J, Corboy J, Jeffery D, Cohen B, Mankowski K, Guarnaccia J, Schaeffer L, Kanter R, Brandes D, Kaufman C, Duncan D, Marder E, Allen A, Harney J, Cooper J, Woo D, Stüve O, Racke M, Frohman EM: Factors that influence adherence with disease-modifying therapy in MS. J Neurol 2009, 256(4):568-576.
7. Oliver BJ, Kohli E, Kasper LH: Interferon therapy in relapsing-remitting multiple sclerosis: a systematic review and meta-analysis of the comparative trials. J Neurol Sci 2011, 302(1-2):96-105.
8. La Mantia L, Munari LM, Lovati R: Glatiramer acetate for multiple sclerosis. Cochrane Database Syst Rev 2010, 5, CD004678.
9. 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, 362(5):402-415.
10. 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(5):387-401.
11. Montalban X, Comi G, O'Connor P, Gold S, de Vera A, Eckert B, Kappos L: Oral fingolimod (FTY720) in relapsing multiple sclerosis: impact on health-related quality of life in a phase II study. Mult Scler 2011, 17(11):1341-1350.
12. Cascione M, Wynn D, Barbato LM, Pestreich L, Schofield L, McCague K: Randomized, open-label study to evaluate patient-reported outcomes with fingolimod after changing from prior disease-modifying therapy for relapsing multiple sclerosis: EPOC study rationale and design. J Med Econ 2013, 16(7):859-865.
13. Fox E, Edwards K, Burch G, Wynn DR, LaGanke C, Crayton H, Hunter SF, Huffman C, Kim E, Pestreich L, McCague K, Barbato L, the EPOC Study Group.: 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(5):607-619.
14. Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L, Lublin FD, Metz LM, McFarland HF, O'Connor PW, Sandberg-Wollheim M, Thompson AJ, Weinshenker BG, Wolinsky JS: Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria". Ann Neurol 2005, 58(6):840-846.
15. 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.
16. Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD: The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol 1989, 46(10):1121-1123.
17. Beck AT, Steer RA, Brown GK: Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation; 1996.
18. Doward LC, McKenna SP, Meads DM, Twiss J, Eckert BJ: The development of patient-reported outcome indices for multiple sclerosis (PRIMUS). Mult Scler 2009, 15(9):1092-1102.
19. Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30(6):473-483.
20. Guy W: ECDEU assessment manual for psychopharmacology. In Rockville, MD: US Department of Heath, Education, and Welfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration; 1976.
21. Radue EW, O'Connor P, Polman CH, Hohlfeld R, Calabresi P, Selmaj K, Mueller-Lenke N, Agoropoulou C, Holdbrook F, de Vera A, Zhang-Auberson L, Francis G, Burtin P, Kappos L, FREEDOMS Study Group: Impact of fingolimod therapy on magnetic resonance imaging outcomes in patients with multiple sclerosis. Arch Neurol 2012, 69(10):1259-1269.
22. Bayas A: Improving adherence to injectable disease-modifying drugs in multiple sclerosis. Expert Opin Drug Deliv 2013, 10(3):285-287.
23. Jensen LH, Osterlind K, Rytter C: Randomized cross-over study of patient preference for oral or intravenous vinorelbine in combination with carboplatin in the treatment of advanced NSCLC. Lung Cancer 2008, 62(1):85-91.
24. Osborne RH, De Abreu LR, Dalton A, Houltram J, Dowton D, Joshua DE, Lindeman R, Ho PJ: Quality of life related to oral versus subcutaneous iron chelation: a time trade-off study. Value Health 2007, 10(6):451-456.
25. Twelves C, Gollins S, Grieve R, Samuel L: A randomised cross-over trial comparing patient preference for oral capecitabine and 5-fluorouracil/leucovorin regimens in patients with advanced colorectal cancer. Ann Oncol 2006, 17(2):239-245.
26. Hemmett L, Holmes J, Barnes M, Russell N: What drives quality of life in multiple sclerosis? QJM 2004, 97(10):671-676.
27. Giovannoni G: Multiple sclerosis related fatigue. J Neurol Neurosurg Psychiatry 2006, 77(1):2-3.
28. Putzki N, Katsarava Z, Vago S, Diener HC, Limmroth V: Prevalence and severity of multiple-sclerosis-associated fatigue in treated and untreated patients. Eur Neurol 2008, 59(3-4):136-142.
29. Fisk JD, Pontefract A, Ritvo PG, Archibald CJ, Murray TJ: The impact of fatigue on patients with multiple sclerosis. Can J Neurol Sci 1994, 21(1):9-14.
30. Claxton AJ, Cramer J, Pierce C: A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001, 23(8):1296-1310.
31. Bakshi R, Shaikh ZA, Miletich RS, Czarnecki D, Dmochowski J, Henschel K, Janardhan V, Dubey N, Kinkel PR: Fatigue in multiple sclerosis and its relationship to depression and neurologic disability. Mult Scler 2000, 6(3):181-185.
32. Kroencke DC, Lynch SG, Denney DR: Fatigue in multiple sclerosis: relationship to depression, disability, and disease pattern. Mult Scler 2000, 6(2):131-136.
33. Schwartz CE, Coulthard-Morris L, Zeng Q: Psychosocial correlates of fatigue in multiple sclerosis. Arch Phys Med Rehabil 1996, 77(2):165-170.
34. Ford H, Trigwell P, Johnson M: The nature of fatigue in multiple sclerosis. J Psychosom Res 1998, 45(1):33-38.
35. Patten SB, Beck CA, Williams JV, Barbui C, Metz LM: Major depression in multiple sclerosis: a population-based perspective. Neurology 2003, 61(11):1524-1527.
36. Zephir H, De Seze J, Stojkovic T, Delisse B, Ferriby D, Cabaret M, Vermersch P: Multiple sclerosis and depression: influence of interferon beta therapy. Mult Scler 2003, 9(3):284-288.
37. Schulz KF, Chalmers I, Hayes RJ, Altman DG: Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995, 273(5):408-412.
38. Rinaldi F, Seppi D, Calabrese M, Perini P, Gallo P: Switching therapy from natalizumab to fingolimod in relapsing-remitting multiple sclerosis: clinical and magnetic resonance imaging findings. Mult Scler 2012, 18(11):1640-1643.
39. Sempere AP, Martin-Medina P, Berenguer-Ruiz L, Perez-Carmona N, Sanchez-Perez R, Polache-Vengud J, Feliu-Rey E: Switching from natalizumab to fingolimod: an observational study. Acta Neurol Scand 2013, 128(2):e6-e10.
40. Devonshire V, Havrdova E, Radue EW, O'Connor P, Zhang-Auberson L, Agoropoulou C, Haring DA, Francis G, Kappos L: Relapse and disability outcomes in patients with multiple sclerosis treated with fingolimod: subgroup analyses of the double-blind, randomised, placebo-controlled FREEDOMS study. Lancet Neurol 2012, 11(5):420-428.