Natalizumab treatment reduces fatigue in multiple sclerosis. Results from the TYNERGY trial; a study in the real life setting.

PLoS One 2013 21;8(3):e58643. Epub 2013 Mar 21.

Dept of Pharmacology and Clinical Neuroscience, Umeå University and University Hospital of Northern Sweden, Umeå, Sweden.

Unlabelled: 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.

Conclusion: 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.

Trial Registration: ClinicalTrials.gov NCT00884481.

Download full-text PDF

Source
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0058643PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3605436PMC
September 2013
10 Reads

Publication Analysis

Top Keywords

fatigue
8
multiple sclerosis
8
ms-related fatigue
8
natalizumab treatment
8
natalizumab
4
aimed evaluate
4
variables fatigue
4
study aimed
4
effects natalizumab
4
fatigue one-armed
4
one-armed clinical
4
measured variables
4
treatment ms-related
4
tynergy study
4
evaluate effects
4
reduce ms-related
4
score quality
4
indicated natalizumab
4
treatment evaluate
4
quality life
4

Similar Publications