Sleep

Longitudinal effects of dimethyl fumarate on patient-reported outcome measures in multiple sclerosis: treatment satisfaction, quality of life, depressive symptoms, sleep, and work productivity.

TL;DR

DMF was associated with improvements in treatment satisfaction, quality of life, sleep quality, work productivity, and depressive symptoms in both treatment-naïve and previously treated RRMS patients, with high adherence and manageable side effects.

Key Findings

Treatment satisfaction improved significantly across all TSQM-14 domains among previously treated RRMS patients switching to DMF over 12 months.

  • Improvements were observed in effectiveness (+13.01), side effects (+7.76), convenience (+35.21), and global satisfaction (+15.75)
  • All domain improvements were statistically significant (all p < 0.001)
  • This was the primary endpoint of the PROFIT study
  • The previously treated subgroup had switched from injectable therapies to DMF

Health-related quality of life improved significantly from baseline to 12 months as measured by EQ-5D-3L.

  • EQ-5D-3L utility score increased by +0.07 (p < 0.001)
  • EQ-5D Visual Analogue Scale (VAS) increased by +3.86 (p < 0.001)
  • Assessments were conducted at baseline, 6 months, and 12 months
  • 645 patients were enrolled (72.3% female; mean age 34.0 years)

Sleep quality improved significantly over the 12-month DMF treatment period.

  • Pittsburgh Sleep Quality Index (PSQI) score decreased by -1.62 (p < 0.001), indicating improved sleep
  • Lower PSQI scores reflect better sleep quality
  • Assessments were conducted at baseline, 6 months, and 12 months

Work productivity impairment (absenteeism) improved significantly over 12 months of DMF treatment.

  • WPAI-MS absenteeism decreased by -7.55% (p < 0.001)
  • Work productivity was assessed using the Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS) questionnaire
  • Assessments were conducted at baseline, 6 months, and 12 months

Depressive symptoms showed a statistically significant improvement over 12 months of DMF treatment.

  • Beck Depression Inventory-Fast Screen (BDI-7) score decreased by -0.11 (p < 0.001)
  • The magnitude of change in BDI-7 was small compared to other outcome measures
  • Assessments were conducted at baseline, 6 months, and 12 months

A substantial proportion of patients discontinued DMF within 12 months, primarily due to gastrointestinal adverse events.

  • 172 of 645 patients (26.7%) discontinued treatment before 12 months
  • 473 patients (73.3%) completed the 12-month follow-up
  • Gastrointestinal adverse events were the leading cause of discontinuation (n=45, 26.0% of discontinuations)
  • Other causes of discontinuation included physician decision (n=34, 20.0%), disease progression (n=26, 15.0%), patient preference (n=19, 11.0%), pregnancy (n=14, 8.0%), and elevated liver enzymes (n=13, 7.0%)

Adverse events declined over time during the 12-month DMF treatment period, supporting a manageable safety profile.

  • A slow-dose titration regimen was used to mitigate gastrointestinal adverse effects
  • Adverse events were monitored monthly
  • Safety was evaluated as a secondary outcome
  • The study confirmed "a favorable and manageable safety profile"

The PROFIT study enrolled a predominantly young, female Iranian RRMS population in a real-world observational setting.

  • 645 patients were enrolled across multiple centers in Iran
  • 72.3% were female and the mean age was 34.0 years
  • The study was a 12-month, multicenter, phase 4, open-label, single-arm observational study
  • Patients were either treatment-naïve or switching from injectable therapies

What This Means

This research examined how a multiple sclerosis (MS) drug called dimethyl fumarate (DMF), sold under names like Tecfidera, affected patients' daily lives over one year in Iran. Rather than just measuring clinical outcomes like relapse rates, the study focused on how patients themselves felt about their treatment — including their satisfaction with the medication, quality of life, mood, sleep, and ability to work. Over 640 patients with relapsing-remitting MS (the most common form) participated, either starting DMF for the first time or switching to it from older injectable medications. This research suggests that taking DMF for 12 months was associated with meaningful improvements across all of these patient-reported measures. Patients reported higher satisfaction with their treatment, better quality of life, improved sleep, fewer days missed from work, and a slight reduction in depressive symptoms. These improvements were statistically significant across all measures. About 73% of patients completed the full 12-month study, while roughly 27% stopped early — most commonly due to gastrointestinal side effects like nausea or flushing, though the frequency of these side effects decreased over time, particularly when the dose was increased gradually at the start of treatment. This study matters because it provides real-world evidence — not just controlled trial data — that DMF can improve multiple dimensions of patients' lives beyond simply reducing MS relapses. The findings are particularly relevant for understanding how this oral medication compares to older injectable therapies in terms of patient experience. The results from this Iranian cohort add to the global evidence base and suggest that DMF may be a well-tolerated, patient-centered treatment option for people with relapsing-remitting MS.

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Citation

Abolfazli R, Sahraian M, Shaygannejad V, Ashtari F, Shahmohammadi S, Poursadeghfard M, et al.. (2026). Longitudinal effects of dimethyl fumarate on patient-reported outcome measures in multiple sclerosis: treatment satisfaction, quality of life, depressive symptoms, sleep, and work productivity.. Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia. https://doi.org/10.1016/j.jocn.2026.111877