The decision to start on disease-modifying therapy is a common one for newly diagnosed MS patients. The question most often asked is: Which drug should I take? The decision to stop using a disease-modifying drug is much more difficult. Patients and neurologists may question what will happen to their disease if patients stop therapy.
New research suggests that it may be safe to stop taking disease-modifying medication if your MS has been stable for an extended period of time. In a recent study published in the the journal Arq Neuropsiquiatr, researchers in Brazil followed a group of 40 patients with relapsing-remitting MS for whom their disease had been clinically and radiologically stable for more than five years and who voluntarily chose to stop using disease-modifying therapy.
Patients included in the study had continuously used one of the following immunomodulatory disease-modifying drugs - Avonex, Betaseron, Rebif, Copaxone - for more than 5 years and up to 14 years. To be included in the study, participants had to be disease-free for at least 5 years while on therapy. Disease-free activity was defined as no clinical relapse, no sustained increase in disability as measured by EDSS (expanded disability status scale) score, and no new gadolinium-enhancing or active lesions as seen on MRI scans.
Patients who had a progressive form of MS and/or who experienced an aggressive clinical or radiological course of the disease were excluded from the study. Patients who had used other immunosuppressive medication and/or had used one of the disease-modifying drugs mentioned above for less than 5 years were excluded as well.
The group of 40 participants were 90% female with an average age of MS onset at 29.2 years. Time between disease onset and diagnosis was 57.6 ±53.1 months. The number of attacks for participants prior to DMT treatment was 2.7 ±1.0 which included sensory attacks (65.8%), motor attacks (7.9%), and other attacks involving the brain stem, cerebellum, or spinal cord (26.3%). Average EDSS at beginning of treatment was 1.21 ±0.68.
Each of the 40 participants stopped using their chosen DMT between 2005 and 2011 and were followed between 13 to 86 months. Average time without DMT medication was 46.3 ±16.3 months. Throughout the study, new MRI images were taken every six months and when a patient experienced a relapse. If patients had a relapse or developed new lesions, they were started back on disease-modifying therapy.
During the time the patients were followed, four patients (10%) experienced new relapses. An additional two patients (5%) developed new lesions that did not correspond to clinical attacks. The relapses occurred in the 4 patients at 34, 46, 62, and 72 months, respectively, after they stopped DMT treatment. Three patients presented with sensory symptoms, and one presented with motor symptoms. Only one patient experienced a persistent increase in disability after MRI worsening with an EDSS increase from 1.0 to 1.5.
The analysis of 40 patients, after DMT withdrawal with mean follow-up of 46.3 months, revealed 90% of attack-free patients; 85% with stable MRI after DMT withdrawal; 85% of disease activity-free patients and 97.5% EDSS stability in patients.
While the results of this study are quite positive, researchers emphasize that the decision to stop DMT treatment in clinically and radiologically stable RRMS patients requires careful consideration. They suggest that a number of favorable prognosis factors be considered before suggesting DMT withdrawal. These factors include: full recovery from the first attack, long gaps between the first and second attacks, the first symptoms being of a sensory nature, and the presence of few gadolinium-enhanced lesions on baseline MRI.
The researchers who conducted this small study in Brazil point out that most of their patients had several favorable prognosis factors, such as presenting with a majority of sensory attacks (65.8%) and a low baseline EDSS score at the beginning of treatment (1.21 on average). Only one patient had an EDSS increase of 0.5 points at the end of the study, increasing the group’s average EDSS score to 1.22 at the end of the study.
In the real world, patients use DMTs for much longer periods of time than are included in the clinical trials designed to prove drug safety and efficacy and which are used for FDA approval. Consensus in the neurology field is that patients should stay on treatment continuously for long periods of time (or indefinitely), but the length of treatment needed to achieve maximum benefit is unknown.
The decision to stop treatment for reasons other than lack of efficacy or undesirable side-effects is a difficult one to make. However, authors suggest that medication withdrawal is an option for a select group of patients. Authors also suggest that these patients should continue to be evaluated periodically and that DMT treatment should be reintroduced if new attacks, new lesions, or increased disability occur.
Before making any decisions regarding disease-modifying treatment, talk to your neurologist to choose an appropriate approach to fit your personal situation. Do not stop taking any prescribed medication without talking with your doctor.
Olival GS, Cavenaghi VB, Serafim V, Thomaz RB, Tilbery CP. Medication withdrawal may be an option for a select group of patients in relapsing-remitting multiple sclerosis. Arq Neuropsiquiatr 2013 Aug;71(8):516-520. doi: 10.1590/0004-282X20130081. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/23982008 .