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Clinical Trial
. 2025 Feb;31(2):159-173.
doi: 10.1177/13524585241303489. Epub 2025 Jan 21.

DISCOntinuation of disease-modifying therapies in MS: The DISCOMS extension trial

John R Corboy  1 , Robert J Fox  2 , Gary Cutter  3 , Eric Engebretson  1 , Aaron Miller  4 , Charity Morgan  3 , Tarah Gustafson  5 , Andrew D Goodman  6 , Meena Kannan  7 , Subramanian Sriram  8 , Zongqi Xia  9 , Sharon Lynch  10 , James Bowen  11 , Ilya Kister  12
Affiliations
Clinical Trial

DISCOntinuation of disease-modifying therapies in MS: The DISCOMS extension trial

John R Corboy et al. Mult Scler. 2025 Feb.

Abstract

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.

Keywords: Multiple sclerosis; age; discontinuation; disease-modifying therapy; extension.

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Conflict of interest statement

Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: J.R.C. declares institutional support from Patient-Centered Outcomes Research Institute (PCORI) and the National Multiple Sclerosis Society (NMSS) for this study; institutional support for research from the National Institutes of Health (NIH), Novartis, and EMD Serono; speaking honorarium from MS Xchange, the University of Chicago, Emory University, The Ohio State University, and the European Committee For Treatment And Research In Multiple Sclerosis (ECTRIMS); a fee for sitting on a Medical Advisory board of Bristol Myers Squib; being Associate Editor for Annals of Neurology and Former Editor in Chief of Neurology: Clinical Practice; and being paid Medical Director of the Rocky Mountain Multiple Sclerosis Center. R.J.F. declares research funding for this trial from PCORI and the NMSS; other research funding from NMSS, the National Institute of Neurological Disorders and Stroke, the National Institute on Aging, the National Institute of Biomedical Imaging and Bioengineering, Biogen, Novartis, and Sanofi; consulting fees from AGB Science, Biogen, Celgene, EMD Serono, Genentech, Genzyme, Greenwich Biosciences, Immunic, Janssen, Novartis, Sanofi, and TG Therapeutics; and participation on an advisory board for AB Science. G.C. declares institutional funding from PCORI for this study; fees for consulting or participating in advisory boards for Alexion, Antisense Therapeutics/Percheron, Avotres, Biogen, Clene Nanomedicine, Clinical Trial Solutions LLC, Endra Life Sciences, Cognito Therapeutics, Genzyme, Genentech, Hoya Corporation, Immunic, Immunosis Pty Ltd, Klein-Buendel Incorporated, Linical, Merck/Serono, Perception Neurosciences, Protalix Biotherapeutics, Regeneron, Roche, SAB Biotherapeutics, Sapience Therapeutics, Scott&Scott LLP; he is President of Pythagoras, Inc. a private consulting company located in Birmingham AL; travel support from Roche; and participation in Data and Safety Monitoring Boards for Applied Therapeutics, AI therapeutics, AMO Pharma, Argenx, Astra-Zeneca, Avexis Pharmaceuticals, Bristol Meyers Squibb/Celgene, CSL Behring, Cynata Therapeutics, DiameticaTherapeutics, Horizon Pharmaceuticals, Immunic, Inhibrix, Karuna Therapeutics, Kezar Life Sciences, Medtronic, Merck, Mitsubishi Tanabe Pharma Holdings, Prothena Biosciences, Novartis, Pipeline Therapeutics (Contineum), Regeneron, Sanofi-Aventis, Reata Pharmaceuticals, Teva Pharmaceuticals, United BioSource LLC, University of Texas Southwestern, Visioneering Technologies, Inc. A.M. declares institutional research support from Genzyme/Sanofi, Roche/Genentech, Novartis, and MedDay; consulting fees from AbbVie, Accordant Health Services, Adamas, Banner Life Sciences, Biogen Idec, Corevitas, Bristol Myers Squibb, Celgene, Janssen, Mapi Pharma, Novartis, Roche/Genentech, Verana Health, and Viatris/Mylan; speaker fees from Biogen Idec, EMD Serono, Alexion, Genentech, and Horizon Therapeutics; and acting as a medical expert in a legal case. A.D.G. has received personal compensation for consulting, serving on a scientific advisory board, or educational activities from Genentech-Roche, IMCYSE, Janssen, Novartis and research support from Atara, Genentech-Roche, Sanofi Genzyme. Z.X. has served as a Consultant for Genentech/Roche and Optum Life Sciences. The institution of Dr. Xia has received research support from the National Institute of Health, the National Multiple Sclerosis Society, Food and Drug Administration, the Pittsburgh Foundation, the PNC Charitable Trust, the Ethel Vincent Trust, and Genentech/Roche. S.L. has participated in Multicenter clinical trials sponsored by Novartis, Sanofi, Biogen, BMS, Roche, TG Therapeutics, Anokion, Celgene, Immunic, Contineum, NMSS, and PCORI; and has received support in Investigator initiated studies funded by the NMSS and DOD. J.B. has received honoraria for serving on the scientific advisory board and speaker’s bureau of Biogen, Celgene, EMD Serono, Genentech and Novartis; has received research support from AbbVie Inc, Alexion, Alkermes, Biogen, Celgene, Sanofi Genzyme, Genentech, Novartis, and TG Therapeutics; is a shareholder of Amgen. I.K. declares institutional support for this study from PCORI and NMSS; institutional support for research from Genentech, Biogen, and NMSS; consulting fees from Roche; royalties from Kluwer-Walters; and fees for sitting on an advisory board from Horizon All other authors declare no competing interests.

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