Disease-modifying therapies (DMTs) discontinuation in older relapsing-remitting multiple sclerosis (RRMS) patients with stable disease: Two-year randomized, controlled trial.
- 1Department of Neurology, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.
- 2Department of Epidemiology, Research Center for Health Sciences, Hamadan University of Medical Sciences, Hamadan, Iran.
- 3Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Abstract
Background
Disease-modifying therapies (DMTs) are the mainstay of relapsing-remitting multiple sclerosis (RRMS) treatment. Their efficacy decreases with age, while risks such as infections increase. This study aimed to evaluate the safety and clinical outcomes of DMT discontinuation in patients with RRMS aged 55 years and older.Methods
We conducted a randomized clinical trial including 178 patients with RRMS aged ≥55 years, EDSS ≤3, and no relapses or MRI activity for at least 5 years. Patients were randomized to continue DMTs (n=89) or discontinue (n=89). Clinical relapses, EDSS scores, and MRI activity were assessed over 24 months.Results
Relapses occurred in 9 (10.7%) patients in the continuation group and 12 patients (14.3%) in the discontinuation group (Risk Ratio [RR] = 1.33, 95% CI: 0.60 to 2.98; P=0.48). MRI activity was detected in 6 patients (7.1%) continuing DMTs and 9 (10.7%) patients who discontinued (RR = 1.50, 95% CI: 0.56 to 4.02; P=0.41). EDSS scores increased slightly in both groups during the first year. At 24 months, the mean EDSS was 1.59 (±0.74) in the continuation group and 1.36 (±0.74) in the discontinuation group, with no statistically significant difference between groups (mean difference = 0.23, 95% CI: -0.002 to 0.46; P=0.05).Conclusion
In patients aged ≥55 years with stable RRMS, discontinuation of DMTs did not significantly increase relapses, disability progression, or MRI activity compared with continuation. These findings suggest that DMT discontinuation may be a safe and reasonable option for selected older patients. Larger, multicenter studies with longer follow-ups are warranted.
Related
- Disease-modifying therapies in managing disability worsening in adult relapsing multiple sclerosis: a population-based longitudinal study using the MSBase registry
- The role of sitagliptin in modifying metabolic, hormonal and clinical parameters in polycystic ovarian syndrome patients: a randomized controlled trial
- Durability of Semaglutide Effects After Treatment Discontinuation in HIV-Associated Lipohypertrophy: A Randomized, Double-Blind, Placebo-Controlled Phase 2b Clinical Trial.
- Comparative efficacy and safety of targeted disease-modifying therapies in adults with primary IgA nephropathy: a systematic review and network meta-analysis
- Efficacy of Disease-Modifying Treatments in Transthyretin Amyloid Cardiomyopathy: A Systematic Review and Meta-Analysis of Five Phase III Randomized Controlled Trials
BibTeX
@article{daneshyar2026diseasemodifying,
title = {{Disease-modifying therapies (DMTs) discontinuation in older relapsing-remitting multiple sclerosis (RRMS) patients with stable disease: Two-year randomized, controlled trial.}},
author = {Sajjad Daneshyar and Masoud Ghiasian and Salman Khazaei and Kimia Alborzi and Maryam Ebadi},
journal = {Caspian journal of internal medicine},
year = {2026},
month = sep,
doi = {10.22088/cjim.17.3.598},
url = {https://europepmc.org/article/MED/42924257},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Disease-modifying therapies (DMTs) discontinuation in older relapsing-remitting multiple sclerosis (RRMS) patients with stable disease: Two-year randomized, controlled trial.
AU - Sajjad Daneshyar
AU - Masoud Ghiasian
AU - Salman Khazaei
AU - Kimia Alborzi
AU - Maryam Ebadi
PY - 2026
DA - 2026/09/01
JO - Caspian journal of internal medicine
DO - 10.22088/cjim.17.3.598
UR - https://europepmc.org/article/MED/42924257
AB - Background Disease-modifying therapies (DMTs) are the mainstay of relapsing-remitting multiple sclerosis (RRMS) treatment. Their efficacy decreases with age, while risks such as infections increase. This study aimed to evaluate the safety and clinical outcomes of DMT discontinuation in patients with RRMS aged 55 years and older.Methods We conducted a randomized clinical trial including 178 patients with RRMS aged ≥55 years, EDSS ≤3, and no relapses or MRI activity for at least 5 years. Patients were randomized to continue DMTs (n=89) or discontinue (n=89). Clinical relapses, EDSS scores, and MRI activity were assessed over 24 months.Results Relapses occurred in 9 (10.7%) patients in the continuation group and 12 patients (14.3%) in the discontinuation group (Risk Ratio [RR] = 1.33, 95% CI: 0.60 to 2.98; P=0.48). MRI activity was detected in 6 patients (7.1%) continuing DMTs and 9 (10.7%) patients who discontinued (RR = 1.50, 95% CI: 0.56 to 4.02; P=0.41). EDSS scores increased slightly in both groups during the first year. At 24 months, the mean EDSS was 1.59 (±0.74) in the continuation group and 1.36 (±0.74) in the discontinuation group, with no statistically significant difference between groups (mean difference = 0.23, 95% CI: -0.002 to 0.46; P=0.05).Conclusion In patients aged ≥55 years with stable RRMS, discontinuation of DMTs did not significantly increase relapses, disability progression, or MRI activity compared with continuation. These findings suggest that DMT discontinuation may be a safe and reasonable option for selected older patients. Larger, multicenter studies with longer follow-ups are warranted.
SN - 2008-6164
SN - 2008-6172
ER -