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| Item Type: | Article |
|---|---|
| Title: | Longitudinal effects of dimethyl fumarate on patient-reported outcome measures in multiple sclerosis: treatment satisfaction, quality of life, depressive symptoms, sleep, and work productivity |
| Creators Name: | Abolfazli, Roya, Sahraian, Mohammad Ali, Shaygannejad, Vahid, Ashtari, Fereshteh, Shahmohammadi, Sareh, Poursadeghfard, Maryam, Baghbanian, Seyed Mohammad, Majdinasab, Nastaran, Nahayati, Mohammad Ali, Hosseini, Samaneh, Azarfam, Javad Yousefi, Navardi, Samira, Torabi, Hamid Reza, Ayromlou, Hormoz, Saeidi, Morteza, Talebi, Mahnaz, Nikseresht, Alireza, Niknam, Zahra, Azimi, Amirreza, Sedighi, Behnaz, Ghiasian, Masoud, Ghalyanchi-Langroodi, Hamidreza, Pourakbar, Ebrahim, Heidari, Hora, Kamali, Hoda, Mohammadianinejad, Ehsan, Ghaffari, Mehran, Mosarrezaii, Arash, Bayati, Asghar, Yaseri, Mehdi, Shali, Abbas and Samadzadeh, Sara |
| 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-naïve 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-naïve 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. |
| Keywords: | Dimethyl Fumarate, Relapsing-Remitting Multiple Sclerosis, Patient-Reported Outcome Measures (PROMs), Treatment Satisfaction, Quality of Life |
| Source: | Journal of Clinical Neuroscience |
| ISSN: | 0967-5868 |
| Publisher: | Elsevier |
| Volume: | 146 |
| Page Range: | 111877 |
| Date: | April 2026 |
| Official Publication: | https://doi.org/10.1016/j.jocn.2026.111877 |
| PubMed: | View item in PubMed |
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