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Multiple sclerosis relapses are associated with increased fatigue and reduced health-related quality of life – A post hoc analysis of the TEMSO and TOWER studies

Multiple Sclerosis and Related Disorders, Volume 7, May 2016, Pages 33–40

Abstract

Background

Two pivotal phase 3 teriflunomide studies provided data on relapses, fatigue, and health-related quality of life (HRQoL) in patients with relapsing forms of multiple sclerosis (MS).

Objectives

Using pooled data from the TEMSO (NCT00134563) and TOWER (NCT00751881) studies, we investigated the association between relapse severity, and changes from baseline to Week 108 in fatigue and HRQoL outcomes.

Methods

Four definitions of relapse severity were applied in this analysis: sequelae post-relapse; relapse leading to hospitalization; relapse requiring intravenous corticosteroids; and intense relapse. We assessed the association between relapse severity and changes in Fatigue Impact Scale score (n=959), physical and mental health component summary scores from the Short Form (SF)-36 questionnaire (n=904), and SF-6D utility index scores (n=820).

Results

Irrespective of the definition of relapse severity applied, in patients experiencing severe relapse(s), fatigue was increased and HRQoL was decreased; these changes were statistically significant (p<0.0001), and were also clinically significant in many cases. The greatest worsening in fatigue and HRQoL was observed in patients with relapses leading to hospitalization.

Conclusions

Given that severe relapses adversely affect patient-reported fatigue and HRQoL, prevention of severe relapses should be an important therapeutic aim in the treatment of patients with MS.

Highlights

  • We used data from >900 MS patients from the TEMSO and TOWER teriflunomide trials.
  • Patient-reported health-related quality of life (HRQoL) and fatigue were assessed.
  • We used four definitions to identify severe MS relapses.
  • Some 420 patients had relapse(s); most met at least one definition of severe relapse.
  • Patients experiencing severe relapse(s) had worsening in fatigue and HRQoL

Abbreviations: ARR - annualized relapse rate, EDSS - Expanded Disability Status Scale, FIS - fatigue impact scale, FS - functional system, HRQoL - health-related quality of life, MCS - (short form 36) mental health component summary, MID - minimally important difference, PCS - (short form 36) physical health component summary, QoL - quality of life, SF-6D - short form 6-dimension, SF-36 - short form 36.

Keywords: Multiple sclerosis, Quality of life, SF-36, FIS, Relapse, Sequelae, Teriflunomide, Fatigue.

Footnotes

a Klinik für Neurologie, Caritas Krankenhaus Bad Mergentheim, Uhlandstraße 7, 97980 Bad Mergentheim, Germany

b Department of Neurology and Institute of Experimental Neurology, University Vita-Salute San Raffaele, Via Olgettina 60, 20132 Milan, Italy

c University of Ottawa and the Ottawa Hospital Research Institute, The Ottawa Hospital – General Campus, 501 Smyth Road, Ottawa, ON, Canada K1H 8L6

d Neurology, Departments of Medicine, Clinical Research and Biomedicine, University Hospital Basel, Petersgraben 4, CH-4031 Basel, Switzerland

e Neuroimmunology Unit, Department of Clinical Neurosciences, Karolinska Hospital, CMM L8:04, 17176 Stockholm, Sweden

f Department of Diagnostic and Interventional Imaging, University of Texas Health Science Center at Houston, 6431 Fannin Street, Houston, TX 77030, USA

g Corinne Goldsmith Dickinson Center for MS, Icahn School of Medicine at Mount Sinai, 5 East 98th Street, Box 1138, New York, NY 10029, USA

h Health Economics/Outcomes Research, Sanofi Genzyme, 1 Avenue Pierre Brossolette, 91385 Chilly-Mazarin, France

i St Michael’s Hospital, Division of Neurology, 30 Bond Street, Toronto, ON, Canada M5B 1W8

Corresponding author.