title: Natalizumab treatment reduces fatigue in multiple sclerosis. Results from the TYNERGY trial; a study in the real life setting.
abstract: Fatigue is a significant symptom in multiple sclerosis (MS) patients. First-generation disease modifying therapies (DMTs) are at best moderately effective to improve fatigue. Observations from small cohorts have indicated that natalizumab, an antibody targeting VLA-4, may reduce MS-related fatigue. The TYNERGY study aimed to further evaluate the effects of natalizumab treatment on MS-related fatigue. In this one-armed clinical trial including 195 MS patients, natalizumab was prescribed in a real-life setting, and a validated questionnaire, the Fatigue Scale for Motor and Cognitive functions (FSMC), was used both before and after 12 months of treatment to evaluate a possible change in the fatigue experienced by the patients. In the treated cohort all measured variables, that is, fatigue score, quality of life, sleepiness, depression, cognition, and disability progression were improved from baseline (all p values<0.0001). Walking speed as measured by the six-minute walk-test also increased at month 12 (p = 0.0016). All patients were aware of the nature of the treatment agent, and of the study outcomes.
  
  
  CONCLUSIONS
  Natalizumab, as used in a real-life setting, might improve MS-related fatigue based on the results from this one-armed un-controlled stud. Also other parameters related to patients' quality of life seemed to improve with natalizumab treatment.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00884481.
authors.affiliation: Dept of Pharmacology and Clinical Neuroscience, Umeå University and University Hospital of Northern Sweden, Umeå, Sweden. anders.svenningsson@neuro.umu.se
authors.forename: Anders
authors.initials: A
authors.lastname: Svenningsson
authors.forename: Eva
authors.initials: E
authors.lastname: Falk
authors.forename: Elisabeth G
authors.initials: EG
authors.lastname: Celius
authors.forename: Siegrid
authors.initials: S
authors.lastname: Fuchs
authors.forename: Karen
authors.initials: K
authors.lastname: Schreiber
authors.forename: Sara
authors.initials: S
authors.lastname: Berkö
authors.forename: Jennifer
authors.initials: J
authors.lastname: Sun
authors.forename: Iris-Katharina
authors.initials: IK
authors.lastname: Penner
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D003071:Cognition / Q000187:drug effects; D003863:Depression / Q000209:etiology / Q000503:physiopathology; D005221:Fatigue / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D039041:Integrin alpha4beta1 / Q000037:antagonists & inhibitors; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000503:physiopathology; D000069442:Natalizumab; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016138:Walking
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D039041:Integrin alpha4beta1; D000069442:Natalizumab
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