Improvement in Fatigue during Natalizumab Treatment is Linked to Improvement in Depression and Day-Time Sleepiness.

Abstract

BACKGROUND:

Fatigue is a frequent symptom in multiple sclerosis (MS) and often interrelated with depression and sleep disorders making symptomatic treatment decisions difficult. In the single-arm, observational phase IV TYNERGY study, relapsing-remitting MS patients showed a clinically meaningful decrease in fatigue over 1 year of treatment with natalizumab.

OBJECTIVE:

To evaluate whether fatigue improvement might be directly linked to improved depression and day-time sleepiness.

METHODS:

Patients were assessed regarding fatigue, depression, and day-time sleepiness. The relation between changes of the two latter symptoms and changes in fatigue was analyzed.

RESULTS:

After 1 year of natalizumab treatment, the majority of patients (>92%) remained stable or improved in total, motor, and cognitive fatigue. Proportion of patients without depression increased by 17% while proportions of mildly depressed patients or patients with potential major depression decreased by 5 and 12%, respectively. Proportion of patients classified as not being sleepy increased by 13% while proportions of sleepy and very sleepy patients decreased by 11 and 2%, respectively. Most importantly, improved depression and sleepiness were significantly related to improved fatigue.

CONCLUSION:

Our findings highlight the importance of patient-reported outcomes in identifying potential benefits of drug treatment beyond its well-established effects on disease activity and disability progression.

• Authors: Iris-Katharina Penner, Eva Catharina Sivertsdotter, Elisabeth G Celius, Siegrid Fuchs, Karen Schreiber, Sara Berkö, Anders Svenningsson, TYNERGY trial investigators
• Journal: Frontiers in neurology (Front Neurol) Vol. 6 Pg. 18 ( 2015) ISSN: 1664-2295 [Print] Switzerland
• PMID: 25755648 (Publication Type: Journal Article)