Impact of treatment with dimethyl fumarate on sleep quality in patients with relapsing-remitting multiple sclerosis: A multicentre Italian wearable tracker study

Abstract

Background Sleep disorders are common in patients with multiple sclerosis and have a bidirectional interplay with fatigue and depression. Objective To evaluate the effect of treatment with oral dimethyl fumarate on the quality of sleep in relapsing-remitting multiple sclerosis. Methods This was a multicentre observational study with 223 relapsing-remitting multiple sclerosis subjects starting treatment with dimethyl fumarate ( n=177) or beta interferon ( n=46). All patients underwent subjective (Pittsburgh Sleep Quality Index) and objective (wearable tracker) measurements of quality of sleep. Fatigue, depression, and quality of life were also investigated and physical activity was monitored. Results Patients treated with dimethyl fumarate had significant improvement in the quality of sleep as measured with the Pittsburgh Sleep Quality Index ( p<0.001). At all-time points, no significant changes in Pittsburgh Sleep Quality Index score were observed in the interferon group. Total and deep sleep measured by wearable tracker decreased at week 12 with both treatments, then remained stable for the total study duration. Depression significantly improved in patients treated with dimethyl fumarate. No significant changes were observed in mobility, fatigue and quality of life. Conclusion In patients with relapsing-remitting multiple sclerosis, the treatment with dimethyl fumarate was associated with improvements in patient-reported quality of sleep. Further randomised clinical trials are needed to confirm the benefits of long-term treatment with dimethyl fumarate.

Sleep Disturbance and Related Factors in the Patients with Relapsing-Remitting Multiple Sclerosis

“…IFN-β and glatiramer acetate were found to prolong sleep-onset latency and cause frequent awakenings at night with poor sleep efficiency and daily somnolence [28,29]. On the contrary, natalizumab was shown to have a positive effect upon fatigue and daytime sleepiness [29] and dimethyl fumarate to ameliorate sleep problems [30]. Our findings demonstrated only slightly higher (on the edge of significance) EDSS score in the subgroup with sleep problems, and distribution of DMT did not differ between the subgroups.…”

Insomnia, Fatigue, Bladder Disorders and Mood Disorders among Polish Patients with Multiple Sclerosis: Cross-Sectional Study

“…As we mentioned above, most of our study group used DMF as a current MS therapy. Comi et al obtained results that PwMS on DMF therapy had better sleep quality [31]. This study's main findings demonstrate that the primary risk factors for developing sleep disorders in individuals with MS were female gender, bladder disorders, and anxiety disorders.…”

“…As compared to Pokryszko-Dragan's study, their cohort of PwMS had a higher rate of insomnia of 49%, a higher EDSS score of 3.2, only 32% of PwMS were treated on interferon (IFN) or glatiramer acetate (GA), and as many as 66% of PwMS did not used DMT [30]. In our study, PwMS showed mild disability with a mean EDSS score of 2.4; what is more, almost all participants received DMT, mainly dimethyl fumarate (DMF), which does not lead to sleep disturbances like IFN or GA [31]. Perhaps due to this, they experienced better sleep quality.…”

Impact of Disease Modifying Therapy on MS-Related Fatigue: A Narrative Review

“…The study explored fatigue as a secondary end point using the FSS. Despite the subjective self-reported improvement in fatigue due to significant positive effect on sleep quality, the study failed to demonstrate significant changes in fatigue, mobility or quality of life over the study duration [17].…”