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DISCOntinuation of disease-modifying therapies in MS: The DISCOMS extension trial
John R Corboy1, Robert J Fox2, Gary Cutter3
1Department of Neurology, University of Colorado School of Medicine, Aurora, CO, USA.
Background:
In the DISCOMS (DISCOntinuation of disease-modifying therapies (DMTs) in multiple sclerosis (MS)) randomized clinical trial, we could not demonstrate that discontinuing MS DMTs in older, stable adults was not inferior to continuing DMTs. Relapses were rare in both groups, and most new disease activity was one to two new brain magnetic resonance imaging (MRI) lesions unassociated with clinical changes.
Objective/Aims:
Describe results of the DISCOMS extension study.
Methods:
Among 10/19 of the original sites, we enrolled patients who completed DISCOMS; did not reach the primary endpoint during the original trial; and retained original randomized assignment. Participants completed one study visit and brain MRI at least 30 months after original enrollment in DISCOMS. Primary endpoint was time from entry into the primary study to relapse or new brain MRI activity.
Results:
Mean (SD) total follow-up was 40 (11.7) months. There were no relapses, and new brain MRI lesions (1/30 continuer, 2/44 discontinuers) were uncommon during the extension. Time from primary trial entry to disease event was significantly shorter for subjects in the discontinue group (p = 0.043 from log-rank test).
Conclusions:
From entry into DISCOMS extension study, time to new MS activity remained shorter in discontinuers, but relapses were absent and new brain MRI lesions were rare.
Insights
Discontinuing disease-modifying therapies (DMTs) for multiple sclerosis (MS) in stable patients did not show non-inferiority to continuing DMTs. New MS disease activity was rare in both groups during the extension study.
Area of Science:
- Neurology
- Clinical Trials
- Immunology
Background:
- The DISCOMS trial investigated discontinuing disease-modifying therapies (DMTs) in stable multiple sclerosis (MS) patients.
- The primary trial did not demonstrate non-inferiority of discontinuing DMTs compared to continuing them.
- New disease activity observed was primarily limited to new brain MRI lesions without clinical symptoms.
Purpose of the Study:
- To report findings from the extension study of the DISCOMS trial.
- To assess long-term outcomes of discontinuing DMTs in MS patients.
Main Methods:
- Patients who completed the DISCOMS trial and met specific criteria were enrolled in the extension study.
- Participants were followed for at least 30 months post-enrollment, with brain MRI assessments.
- The primary endpoint was time to relapse or new brain MRI activity.
Main Results:
- Mean follow-up was 40 months.
- No relapses occurred; new brain MRI lesions were infrequent (1/30 continuers, 2/44 discontinuers).
- Time to a disease event was significantly shorter for patients who discontinued DMTs (p=0.043).
Conclusions:
- Time to new MS activity remained shorter in the DMT discontinuation group during the extension study.
- Relapses were absent, and new brain MRI lesions were rare in both groups.
- The findings suggest a potential difference in disease activity progression between continuing and discontinuing DMTs, despite overall low event rates.
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