Teriflunomide reduces relapses with sequelae and relapses leading to hospitalizations: results from the TOWER study

Journal of Neurology

Volumn 261, Issue 9, 2014, Pages 1781-1788

  Miller, Aaron E ^a   Macdonell, Richard ^b   Comi, Giancarlo ^c   Freedman, Mark S ^d   Kappos, Ludwig ^e   Mäurer, Mathias ^f   Olsson, Tomas P ^g   Wolinsky, Jerry S ^h   Bozzi, Sylvie ⁱ   Dive Pouletty, Catherine ⁱ   O’Connor, Paul W ^j  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b AUSTIN HEALTH   (Australia)

^c VITA SALUTE SAN RAFFAELE UNIVERSITY   (Italy)

^d OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^e UNIVERSITY HOSPITAL BASEL   (Switzerland)

^f CARITAS KRANKENHAUS   (Germany)

^g KAROLINSKA INSTITUTE   (Sweden)

^h UNIVERSITY OF TEXAS   (United States)

ⁱ SANOFI   (France)

^j ST MICHAEL'S HOSPITAL   (Canada)

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Author keywords

Clinical trial; Economics; Multiple sclerosis; Outcome assessment (healthcare); Teriflunomide

Indexed keywords

CORTICOSTEROID; CROTONIC ACID DERIVATIVE; GLUCOCORTICOID; IMMUNOLOGIC FACTOR; TERIFLUNOMIDE; TOLUIDINE DERIVATIVE;

ADULT; CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; FEMALE; HOSPITALIZATION; HUMAN; MALE; MIDDLE AGED; MULTICENTER STUDY; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; ORAL DRUG ADMINISTRATION; PATHOPHYSIOLOGY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RECURRENT DISEASE; SEVERITY OF ILLNESS INDEX; STATISTICS AND NUMERICAL DATA; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ADRENAL CORTEX HORMONES; ADULT; CROTONATES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; GLUCOCORTICOIDS; HOSPITALIZATION; HUMANS; IMMUNOLOGIC FACTORS; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; RECURRENCE; SEVERITY OF ILLNESS INDEX; TOLUIDINES; TREATMENT OUTCOME;

EID: 84939883753     PISSN: 03405354     EISSN: 14321459     Source Type: Journal    
DOI: 10.1007/s00415-014-7395-7     Document Type: Article

References (21)

1. Hauser SL, Oksenberg JR (2006) The neurobiology of multiple sclerosis: genes, inflammation, and neurodegeneration. Neuron 52:61–76
2. Trapp BD, Nave KA (2008) Multiple sclerosis: an immune or neurodegenerative disorder? Ann Rev Neurosci 31:247–269
3. Halper J (2007) The psychosocial effect of multiple sclerosis: the impact of relapses. J Neurol Sci 256(Suppl 1):S34–S38
4. Kalb R (2007) The emotional and psychological impact of multiple sclerosis relapses. J Neurol Sci 256(Suppl 1):S29–S33
5. Oleen-Burkey M, Castelli-Haley J, Lage MJ, Johnson KP (2012) Burden of a multiple sclerosis relapse: the patient’s perspective. Patient 5:57–69
6. Healy BC, Degano IR, Schreck A, Rintell D, Weiner H, Chitnis T et al (2012) The impact of a recent relapse on patient-reported outcomes in subjects with multiple sclerosis. Qual Life Res 21:1677–1684
7. Morrow TJ (2007) The costs and consequences of multiple sclerosis relapses: a managed care perspective. J Neurol Sci 256(Suppl 1):S39–S44
8. Sanofi-aventis (2012) Aubagio tablets: US prescribing information
9. O’Connor P, Wolinsky JS, Confavreux C, Comi G, Kappos L, Olsson TP et al (2011) Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med 365:1293–1303
10. Confavreux C, O’Connor P, Comi G, Freedman MS, Miller AE, Olsson TP et al (2014) Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo controlled, phase 3 trial. Lancet Neurol 13:247–256
11. Confavreux C, Li DK, Freedman MS, Truffinet P, Benzerdjeb H, Wang D et al (2012) Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years. Mult Scler 18:1278–1289
12. Freedman M, Wolinsky J, Comi G, Kappos L, Olsson T, Miller A et al (2013) Long-term safety and efficacy of teriflunomide in patients with relapsing forms of multiple sclerosis in the TEMSO extension trial. Mult Scler 19(S1):74–558
13. O’Connor P, Lublin FD, Wolinsky JS, Confavreux C, Comi G, Freedman MS et al (2013) Teriflunomide reduces relapse-related neurological sequelae, hospitalizations and steroid use. J Neurol 260:2472–2480
14. Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O’Connor P et al (2002) Randomized, comparative study of interferon beta-1a treatment regimens in MS: the EVIDENCE trial. Neurology 59:1496–1506
15. Mäurer M (2013) Impact of severe relapses on disability, fatigue and health-related quality of life outcomes: a pooled dataset of the phase 3 TEMSO and TOWER studies. Mult Scler 19(S1):74–558
16. Curkendall SM, Wang C, Johnson BH, Cao Z, Preblick R, Torres AM et al (2011) Potential health care cost savings associated with early treatment of multiple sclerosis using disease-modifying therapy. Clin Ther 33:914–925
17. Tan H, Yu J, Tabby D, Devries A, Singer J (2010) Clinical and economic impact of a specialty care management program among patients with multiple sclerosis: a cohort study. Mult Scler 16:956–963
18. Weinstock-Guttman B, Galetta SL, Giovannoni G, Havrdova E, Hutchinson M, Kappos L et al (2012) Additional efficacy endpoints from pivotal natalizumab trials in relapsing–remitting MS. J Neurol 259:898–905
19. Havrdova E, Gold R, Fox RJ, Kappos L, Kita M, Yang M et al (2012) Relapses requiring intravenous steroid use and MS-related hospitalisations: findings from the phase 3 DEFINE and CONFIRM studies. Mult Scler 18(S4):279–508
20. Nusrat S, Levinthal D, Bielefeldt K (2013) Hospitalization rates and discharge status in multiple sclerosis. Mult Scler Int 2013:436929
21. O’Brien JA, Ward AJ, Patrick AR, Caro J (2003) Cost of managing an episode of relapse in multiple sclerosis in the United States. BMC Health Serv Res 3:17