Randomized Controlled Trial on Discontinuation of DMTs in Older Patients with RRMS
In a study with 178 patients aged ≥55 years with stable relapsing-remitting multiple sclerosis (RRMS), discontinuing disease-modifying therapies (DMTs) over 24 months did not significantly increase clinical relapses, disability progression, or MRI activity compared to continuing DMTs.
- Tags
- #MSResearch
- Most relevant to
- —
- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- Moderate
- Outcome
- Negative
Why it matters
These findings suggest that older patients with stable RRMS may safely discontinue DMTs without significantly impacting their condition, which could influence treatment decisions for this population.
What this does not prove
The results apply only to patients aged ≥55 years, limiting generalizability to younger patients. Additionally, the follow-up period of 24 months may not capture long-term outcomes.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 178 · basis not reported
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- 2026-09-01
- Evidence reviewed
- Abstract only
- Regulatory approval
- Not reported
- Research areas
- Not classified
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- Not reported
- Size of effect
- Not reported
- Secondary endpoints
- Not reported
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
Supporting passages (11)
limitationsLarger, multicenter studies with longer follow-ups are warranted.
study designWe 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.
subjectsMETHODS: 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.
sample size178 patients with RRMS aged ≥55 years, EDSS ≤3, and no relapses or MRI activity for at least 5 years.
randomizedPatients were randomized to continue DMTs (n=89) or discontinue (n=89).
controlledTwo-year randomized, controlled trial.
peer reviewedPublication types: Journal Article
publication datePublication date: 2026-09-01
primary endpointClinical relapses, EDSS scores, and MRI activity were assessed over 24 months.
outcomeIn patients aged ≥55 years with stable RRMS, discontinuation of DMTs did not significantly increase relapses, disability progression, or MRI activity compared with continuation.
findingsRESULTS: 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).
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