DOT-MS
Trial question
Is discontinuation of first-line disease-modifying therapy noninferior to continuation of disease-modifying therapy in patients with long-term stable multiple sclerosis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
67.0% female
33.0% male
N = 89
89 patients (60 female, 29 male).
Inclusion criteria: adult patients with relapse-onset multiple sclerosis, without relapses for over 5 years.
Key exclusion criteria: switch between first-line disease-modifying therapy over 2 years; pregnancy; previous use of interferon-beta and positive test for neutralizing antibodies.
Interventions
N=45 therapy discontinuation (discontinuation of current disease-modifying therapy).
N=44 therapy continuation (continuation of current disease-modifying therapy).
Primary outcome
Significant inflammatory disease activity
17.8%
0%
17.8 %
13.4 %
8.9 %
4.5 %
0.0 %
Therapy
discontinuation
Therapy
continuation
Significant
increase ▲
NNH = 5
Significant increase in significant inflammatory disease activity (17.8% vs. 0%; AD 17.8%, 95% CI 7.24 to 28.36).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In adult patients with relapse-onset multiple sclerosis, without relapses for over 5 years, therapy discontinuation was inferior to therapy continuation with respect to significant inflammatory disease activity.
Reference
Eline M E Coerver, Wing Hee Fung, Janet de Beukelaar et al. Discontinuation of First-Line Disease-Modifying Therapy in Patients With Stable Multiple Sclerosis: The DOT-MS Randomized Clinical Trial. JAMA Neurol. 2025 Feb 1;82(2):123-131.
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