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Longitudinal Effects of Dimethyl Fumarate on Patient-Reported Outcome Measures in Multiple Sclerosis: Treatment Satisfaction, Quality of Life, Depressive Symptoms, Sleep, and Work Productivity Publisher Pubmed



Abolfazli R ; Sahraian MA ; Shaygannejad V ; Ashtari F ; Shahmohammadi S ; Poursadeghfard M ; Baghbanian SM ; Majdinasab N ; Nahayati MA ; Hosseini S ; Azarfam JY ; Navardi S ; Torabi HR ; Ayromlou H Show All Authors
Authors
  1. Abolfazli R
  2. Sahraian MA
  3. Shaygannejad V
  4. Ashtari F
  5. Shahmohammadi S
  6. Poursadeghfard M
  7. Baghbanian SM
  8. Majdinasab N
  9. Nahayati MA
  10. Hosseini S
  11. Azarfam JY
  12. Navardi S
  13. Torabi HR
  14. Ayromlou H
  15. Saeidi M
  16. Talebi M
  17. Nikseresht A
  18. Niknam Z
  19. Azimi A
  20. Sedighi B
  21. Ghiasian M
  22. Ghalyanchilangroodi H
  23. Pourakbar E
  24. Heidari H
  25. Kamali H
  26. Mohammadianinejad E
  27. Ghaffari M
  28. Mosarrezaii A
  29. Bayati A
  30. Yaseri M
  31. Shali A
  32. Samadzadeh S

Source: Journal of Clinical Neuroscience Published:2026


Abstract

Background Oral therapies for relapsing–remitting multiple sclerosis (RRMS) may enhance treatment satisfaction and quality of life. Patient-reported outcome measures (PROMs) provide structured insight into treatment effectiveness and disease impact beyond clinician-reported scales. Objective To assess treatment satisfaction and other PROMs in RRMS patients initiating dimethyl fumarate (DMF), either treatment-naive or switching from injectable therapies. Methods PROFIT was a 12-month, multicenter, phase 4, open-label, single-arm observational study conducted in Iran. Patients received DMF with a slow-dose titration regimen to mitigate gastrointestinal adverse effects. The primary endpoint was the change in treatment satisfaction, assessed by the Treatment Satisfaction Questionnaire for Medication (TSQM-14), from baseline to month 12 among previously treated patients. Key secondary endpoints included changes in additional PROMs, including health-related quality of life (HRQoL), depressive symptoms, sleep quality, and work productivity. Patient-reported outcomes were assessed using the EuroQol-5D-3L (EQ-5D-3L), Beck Depression Inventory–Fast Screen (BDI-7), Pittsburgh Sleep Quality Index (PSQI), and Work Productivity and Activity Impairment–Multiple Sclerosis (WPAI-MS) at baseline, 6 months, and 12 months. Adverse events were monitored monthly, with safety evaluated as a secondary outcome. Results Of 645 patients (72.3 % female; mean age 34.0 years), 473 (73.3 %) completed the 12-month follow-up, while 172 (26.7 %) discontinued treatment. The primary endpoint, change in treatment satisfaction (TSQM-14) among previously treated patients, showed significant improvement across all domains: effectiveness (+13.01), side effects (+7.76), convenience (+35.21), and global satisfaction (+15.75) (all p < 0.001). Secondary endpoints also demonstrated favorable changes, including EQ-5D-3L utility (+0.07), EQ-5D Visual Analogue Scale (VAS) (+3.86), PSQI (–1.62), WPAI absenteeism (–7.55 %), and BDI-7 (–0.11) (all p < 0.001). Treatment discontinuations (26.7 %) were primarily due to gastrointestinal adverse events (n = 45, 26.0 %), followed by physician decision (n = 34, 20.0 %), disease progression (n = 26, 15.0 %), patient preference (n = 19, 11.0 %), pregnancy (n = 14, 8.0 %), elevated liver enzymes (n = 13, 7.0 %), and other causes (n = 21, 12.0 %). Adverse events declined over time, confirming a favorable and manageable safety profile. Conclusion DMF was associated with improvements in treatment satisfaction, quality of life, sleep quality, work productivity, and depressive symptoms in both treatment-naive and previously treated RRMS patients, with high adherence and manageable side effects. These findings provide real-world evidence from an Iranian RRMS cohort, supporting DMF as a well-tolerated, patient-centered option with multidimensional benefits observed under routine clinical conditions. © 2026 Elsevier Ltd.
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