Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia · 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.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеКлиническое исследование IV фазыНазвание и аннотация: Перевод в очереди
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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, Samadzadeh Sara
Аннотация
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.
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.