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MS research update – When can you safely stop taking disease modifying drugs? – 1 March 2017

Summary

There is very little evidence to suggest who can safely stop taking disease modifying drugs (DMDs). To shed more light on this, an American study has compared the experiences of people who stopped taking DMDs - those advised to stop and those who chose to stop.

The first group consisted of 77 people with secondary progressive MS with no clinical or MRI signs of MS activity for at least 2 years. These people were advised to stop taking DMDs (advised group). The second group consisted of 17 people with relapsing remitting MS who chose to stop taking their DMDs (chose group). People in both groups were assessed at the time of stopping DMDs and monitored for recurrence of MS activity (relapse or MRI lesions) for at least one year after.

12% of those in advised group and 59% of those in chose group had recurrence of MS activity, within 2 years of stopping treatment.

The investigator concluded that it may be safe to stop DMDs in older people (70 years or older) who have been free of MS activity for at least 2 years, although monitoring for recurrence of MS activity is warranted.


Background

There is increasing evidence that it is best to begin treatment of relapsing remitting MS (RRMS) with disease modifying drugs (DMDs) soon after diagnosis. What is much less clear is how to judge when it would be safe to stop taking one of these drugs.

Some people choose to stop taking a DMD because they feel the negative aspects of regularly taking a drug outweigh any benefits they feel they are getting. Others who have been taking a DMD for some years may feel that absence of MS activity shows that the drug they are taking regularly is holding their MS in check and are very concerned when a neurologist suggests that it's now time to stop.

This study aimed to get a clearer picture of who can stop taking DMDs without risk of a return of MS activity in the form of a relapse or lesions seen on an MRI scan.

How this study was carried out

The investigator identified two groups of people with MS.

The first group consisted of 77 people initially diagnosed with relapsing remitting MS, but who had shown no clinical or MRI signs of MS activity for 2 or more years and had been diagnosed with secondary progressive MS. These people were advised to stop taking DMDs (advised group). The second group consisted of 17 people with relapsing remitting MS who chose to stop taking their DMDs (chose group).

On average, the advised group were older than the chose group (61 vs 49 years), had a higher level of disability (EDSS 6 vs EDSS 2), and had been taking DMDs for a longer time (11 vs 7 years).

People in both groups had MRIs and neurological assessments at the time of stopping DMDs and were monitored for recurrence of MS activity (relapse or MRI lesions) for at least one year after.

What was found

12% of those in advised group (9/77) and 59% of those in chose group (10/17) had a return of MS activity, in the form of a relapse or new lesions on a MRI scan, within 2 years of stopping treatment.

In the advised group, four people had a relapse while five had new lesions on their MRIs. Age was the only identifiable difference between those with and without recurrence of MS activity. Those with recurrence of MS activity were slightly younger (average age 56) than those without recurrence were slightly older (average age 61). There was no difference in disability scores (EDSS) between those who did or did not have MS activity recurrence.

In chose group, there was no significant difference in age between those with or without MS activity recurrence.

What does it mean?

This study concluded that DMDs can be stopped safely in older people (70 years or older) who have been free of MS activity for at least 2 years, with a 10% likelihood of further MS activity within 2 years. However, younger people with relapsing remitting MS choosing to stop their DMD have a 60% likelihood of further MS activity, underlining the importance of continuing with treatment for this group.

This small study carried out in a single MS clinic in the United States provides some data to suggest who can safely stop taking a DMD, but also highlights the lack of research that has been undertaken on this subject. Another study is currently underway in the United States looking at the impact of stopping treatment in people older than 55 who have been taking DMDs for five years or more; the target is to recruit 300 participants, half of whom will continue to take their DMD, while the other half will stop. This study will provide further data to help people with MS and their MS teams understand when it may be appropriate to stop treatment.

Birnbaum G.
Stopping disease-modifying therapy in nonrelapsing multiple sclerosis: experience from a clinical practice.
International Journal of MS Care 2017;19:11-14.
Abstract
Read the full text of this paper

More about disease modifying drugs

Disease modifying drugs (DMDs) work with different parts of the immune system to reduce the inflammation caused by MS to nerve cells in the brain and spinal cord. This helps reduce the number and severity of relapses as well as areas of damage (lesions) which may not cause a relapse but show up on an MRI scan. The goal of DMD treatment is to reach a point where you are free of visible (relapses) and invisible (changes seen only on brain scans) MS disease activity.

Over time, people initially diagnosed with relapsing remitting MS will find that relapses happen less often and eventually stop, but disability gradually increases in between relapses and there is a gradual transition to secondary progressive MS. The progressive phase is thought to be caused by permanent loss of nerves rather than new inflammation, so the DMDs are not effective or useful in this stage.

While none of the currently prescribed DMDs have been shown to reduce the progressive disability which happens independently of relapses, a number of drugs are being investigated for the potential to slow down, stop or potentially reverse the progressive disability which occurs in secondary progressive MS.

For more about starting and stopping disease modifying drugs see our Frequently Asked Questions in MS Decisions.

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Ehling R, Bsteh G, Di Pauli F, et al.
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Landi D, De Rossi N, Zagaglia S, et al.
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Sormani MP, Laroni A.
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Kalincik T, Brown JW, Robertson N, et al.
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Hersh CM, Love TE, Cohn S, et al.
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Mult Scler Relat Disord. 2016 Nov;10:44-52.
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Sundgren M, Piehl F, Wahlin Å, et al.
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Mult Scler Relat Disord. 2016 Nov;10:36-43.
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Freedman MS, Montalban X, Miller AE, et al.
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Fogarty E, Schmitz S, Tubridy N, et al.
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Mult Scler Relat Disord. 2016 Sep;9:23-30.
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Giovannoni G, Butzkueven H, Dhib-Jalbut S, et al.
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Mult Scler Relat Disord. 2016 Sep;9 Suppl 1:S5-S48.
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McEwan L, Caon C, Chieffe C, et al.
Best Practices in Alemtuzumab Administration: Practical Recommendations for Infusion in Patients With Multiple Sclerosis.
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Drugs in development

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Giovannoni G, Kappos L, Gold R, et al.
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Bove R, Vaughan T, Chitnis T, et al.
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Baker D, Anandhakrishnan A, Tuite-Dalton KA, et al.
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Mult Scler Relat Disord. 2016 Nov;10:127-133.
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Klein E, Solomon AJ, Corboy J, et al.
Physician compensation for industry-sponsored clinical trials in multiple sclerosis influences patient trust.
Mult Scler Relat Disord. 2016 Jul;8:4-8.
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Prognosis

Javizian O, Metz LM, Deighton S, et al.
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Eur J Neurol. 2017 Feb 26. [Epub ahead of print]
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Sidhom Y, Maillart E, Tezenas du Montcel S, et al.
Fast multiple sclerosis progression in North Africans: Both genetics and environment matter.
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Hempel S, Fu N, Estrada E, et al.
Modifiable Risk Factors in the Progression of Multiple Sclerosis: A Systematic Review of the Epidemiology and Treatment [Internet].
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Psychological aspects

Dulau C, Deloire M, Diaz H, et al.
Social cognition according to cognitive impairment in different clinical phenotypes of multiple sclerosis.
J Neurol. 2017 Feb 20. [Epub ahead of print]
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Butler E, Matcham F, Chalder T.
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Rehabilitation

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Cohen ET, Kietrys D, Fogerite SG, et al.
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Galea MP, Cofré Lizama LE, Butzkueven H, et al.
Gait and balance deterioration over a 12-month period in multiple sclerosis patients with EDSS scores ≤ 3.0.
NeuroRehabilitation. 2017 Feb 6. [Epub ahead of print]
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Poh PY, Adams AN, Huang M, et al.
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Gait Posture. 2017 Feb 8;53:230-235. [Epub ahead of print]
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Corvillo I, Varela E, Armijo F, et al.
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Eur J Phys Rehabil Med. 2017 Feb 17. [Epub ahead of print]
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Neuropsychiatr Dis Treat. 2017 Feb 3;13:245-252.
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Work

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Neurol Sci. 2017 Feb;38(2):349-352.
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