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MS research update - Could intermittent steroid treatment help people with progressive MS? - 6 October 2015

Summary

This study investigated intermittent oral steroid treatment in people with progressive forms of MS. 15 people with primary progressive MS and 15 people with secondary progressive MS in Denmark took part in the study. All participants took oral methylprednisolone at a dose of 500mg for three days every fourth week for a period of 60 weeks.

The study found no change in the levels of markers of inflammation after intermittent steroid treatment. There were improvements seen on the MRI brain scans. There were also significant improvements in EDSS scores and also in scores in several of the questionnaires, most notably in the physical sections of these, such as timed walking tests.

The authors conclude that intermitted steroids may be a beneficial for people with progressive MS. Although they do say that the results should be interpreted with caution, as the study did not have a control group. Additionally everyone involved knew what the drug treatment was, which could affect how people respond to tests and assess the results.

However there is not sufficient evidence from this small study alone to confirm its effects further controlled trials would be required to investigate the use of steroids further.

Background

Currently there are no disease modifying drugs available for people with progressive forms of MS. All of the current disease modifying drugs available work principally through reducing the number and severity of relapses. Steroids are also used in the treatment of relapses, to help speed up recovery. Both of these drug types work to reduce inflammation, which is known to occur in people with relapsing remitting MS. Until recently it was thought that in progressive forms of MS the loss of nerves was more important than damage caused by inflammation. Recent research has shown that inflammation and immune system activation can occur in progressive MS. A couple of previous studies have shown that intravenous steroid treatment can have a positive effect on people with progressive MS. This study investigated intermittent oral steroid treatment in people with primary and secondary progressive MS.

How this study was carried out

15 people with primary progressive MS and 15 people with secondary progressive MS in Denmark took part in the study. They were all aged 18-65 and had an EDSS score of 6.5 or below.

All participants took oral methylprednisolone at a dose of 500mg for three days every fourth week for a period of 60 weeks. The study was an open label study, which means that there was no control group and the researchers and the participants knew the drug they were taking. As steroids can affect the bones, making them weak and brittle participants were also given daily doses of calcium (1000mg) and vitamin D (20µg) to protect their bone health.

At several points at the start, during and at the end of the study period the participants were assessed using:

Participants also completed several questionnaires that examined the impact of MS on their daily lives.

What was found

The study found no change in the levels of markers of inflammation after intermittent steroid treatment. There were improvements seen on the MRI brain scans. There were also significant improvements in EDSS scores and also in scores in several of the questionnaires, most notably in the physical sections of these, such as timed walking tests.

The researchers recorded 125 adverse events (untoward medical occurrences) occurring during the study period, but 97 of these were well known side effects of steroids including insomnia, flushing, metallic tastes and palpitations. Although bone density was found to be unaffected.

What does it mean?

The study shows that intermittent steroid treatment does not necessarily improve inflammation in people with progressive MS, but appears to have some other beneficial effects. Although the researchers do say that the results should be interpreted with caution, as the study did not have a control group. Additionally everyone involved knew what the drug treatment was, which could affect how people respond to tests and assess the results.

The authors conclude that intermitted steroids may be a beneficial for people with progressive MS. However there is not sufficient evidence from this small study alone to confirm its effects further controlled trials would be required to investigate the use of steroids further.

Comment

This study has some interesting results, but the numbers involved are extremely small and the results far from conclusive proof that steroid treatment could be beneficial for people with progressive MS. Further larger trials would be needed, run in hundreds of people over several years to fully investigate their use.

Steroids such as methylprednisolone, are used in several health conditions already, including for the treatment of relapses in people with relapsing remitting MS. However long-term treatment with steroids is usually avoided, and they are usually prescribed at the lowest effective dose for the shortest possible time. This is because of the risk of side effects such as weight gain, acne, cataracts, osteoporosis (thinning of the bones), deterioration of the head of the thigh bone and diabetes. The NICE Guideline recommends that courses of steroids in people with MS be limited to a maximum of three times a year.

Ratzer R, Iversen P, Börnsen L, et al.
Monthly oral methylprednisolone pulse treatment in progressive multiple sclerosis.
Mult Scler. 2015 Oct 2. [Epub ahead of print]
Abstract

More about developing new treatments

The development of new drugs is a long and difficult process. Only one or two compounds in 10,000 tested actually make it through to being licensed treatments. A potential new medicine may be rejected at any point in the development process on safety, effectiveness or quality grounds. Overall, it may take 10-15 years for a new compound to get from the test tube to the medicine cabinet.

Drug licenses are granted for a specific use and in a particular group of people. However clinical trials will continue after a medicine has been granted a license, as the drug may have uses as a treatment for other conditions and these can be tested. If the results of these further trials show the drug has a use in other conditions, an application can be made for the regulator to extend the terms of the current license to the new condition.

Even though a drug may already have a license and be proven to be an effective treatment in one condition, the trials to investigate its use in another condition can still take many years.

There are three types of drug trial:

  • Phase I – the first step in testing a new drug is to determine the safety of single doses in a small number of healthy volunteers.
  • Phase II – if the treatment proves to be safe, studies begin to determine the effectiveness of the drug in people with the condition to be treated. These studies may last several months or years and involve larger numbers of people, perhaps one or two hundred.
  • Phase III – if a drug shows effectiveness, a larger study is conducted in hundreds of people. These clinical trials take place at different locations and across several countries and may last several years. These studies allow researchers to more accurately assess the potential of the new drug in a wider range of people and compare it to existing treatments.

Drug treatments for progressive MS

A couple of the existing disease modifying drugs are being tested in people with primary progressive and secondary progressive MS. These included natalizumab (Tysabri) and fingolimod (Gilenya).

There are several drugs that are currently licensed for other conditions which are being tested in secondary progressive MS. These are riluzole, amiloride and fluoxetine.These are being tested as part of a phase II trial, called MS-SMART, which will study 440 participants over two years and is currently recruiting participants. You can register your interest on their website.

There are also several other drugs that are still experimental that are being investigated and trialled as treatments for progressive forms of MS. These are masitinib, anti-lingo-1 and biotin. Further details and updates will be posted on the MS Trust drugs in development webpage.

Assessment tools

Pilutti LA, Sandroff BM, Klaren RE, et al.
Physical fitness assessment across the disability spectrum in persons with multiple sclerosis: a comparison of testing modalities. 
J Neurol Phys Ther. 2015 Oct;39(4):241-9.
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Ben Mortenson W, Demers L, Rushton PW, et al. 
Exploratory validation of a multidimensional power wheelchair outcomes toolkit.
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Carers

Penwell-Waines L, Goodworth MR, Casillas RS, et al.
Perceptions of caregiver distress, health behaviors, and provider health-promoting communication and their relationship to stress management in MS caregivers.
Health Commun. 2015 Sep 23:1-7. [Epub ahead of print] 
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Co-existing conditions

O'Malley PW, Mulla ZD, Nesic O. 
Multiple sclerosis and breast cancer.
J Neurol Sci. 2015 Sep 15;356(1-2):137-41. Epub 2015 Jun 22. 
Abstract

Disease modifying drugs

Paolicelli D, Manni A, Direnzo V, et al.
Long-term cardiac safety and tolerability of fingolimod in multiple sclerosis: a postmarketing study. 
J Clin Pharmacol. 2015 Oct;55(10):1131-6. Epub 2015 Jun 17. 
Abstract 

Katsarava Z, Ehlken B, Limmroth V, et al.
Adherence and cost in multiple sclerosis patients treated with IM IFN beta-1a: impact of the CARE patient management program. 
BMC Neurol. 2015 Sep 22;15(1):170.
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Faulkner M. 
Risk of progressive multifocal leukoencephalopathy in patients with multiple sclerosis. 
Expert Opin Drug Saf. 2015 Sep 22:1-12. [Epub ahead of print] 
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Zivadinov R, Dwyer MG, Ramasamy DP, et al.
The effect of three times a week glatiramer acetate on cerebral T1 hypointense lesions in relapsing-remitting multiple sclerosis.
J Neuroimaging. 2015 Sep 22. [Epub ahead of print] 
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Moccia M, Palladino R, Russo C, et al. 
How many injections did you miss last month? A simple question to predict interferon β-1a adherence in multiple sclerosis. 
Expert Opin Drug Deliv. 2015 Sep 15:1-7. [Epub ahead of print] 
Abstract

Kappos L, Kuhle J, Multanen J, et al. 
Factors influencing long-term outcomes in relapsing-remitting multiple sclerosis: PRISMS-15. 
J Neurol Neurosurg Psychiatry. 2015 Sep 15. [Epub ahead of print] 
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Drugs in development

Villoslada P, Rovira A, Montalban X, et al.
Effects of diazoxide in multiple sclerosis: a randomized, double-blind phase 2 clinical trial. 
Neurol Neuroimmunol Neuroinflamm. 2015 Sep 10;2(5):e147. eCollection 2015 Oct. 
Abstract
Read the full text of this paper

Economics

Stawowczyk E, Malinowski KP, Kawalec P, Moćko P. 
The indirect costs of multiple sclerosis: systematic review and meta-analysis. 
Expert Rev Pharmacoecon Outcomes Res. 2015 Oct;15(5):759-86. Epub 2015 Jul 18. 
Abstract

Genetics

Lin X, Deng FY, Lu X, Lei SF. 
Susceptibility genes for multiple sclerosis identified in a gene-based genome-wide association study. 
J Clin Neurol. 2015 Oct;11(4):311-8. Epub 2015 Aug 21.
Abstract
Read the full text of this paper

Hormones and MS

Kempe P, Hammar M, Brynhildsen J. 
Symptoms of multiple sclerosis during use of combined hormonal contraception. 
Eur J Obstet Gynecol Reprod Biol. 2015 Oct;193:1-4. Epub 2015 Jul 9. 
Abstract

Triantafyllou N, Thoda P, Armeni E, et al.
Association of sex hormones and glucose metabolism with the severity of multiple sclerosis. 
Int J Neurosci. 2015 Sep 25:1-8. [Epub ahead of print]
Abstract

Other treatments

Turel AP, Oh KH, Zagon IS, McLaughlin PJ. 
Low dose naltrexone for treatment of multiple sclerosis: a retrospective chart review of safety and tolerability. 
J Clin Psychopharmacol. 2015 Oct;35(5):609-11. 
Abstract

Paediatric MS

Cardoso M, Olmo NR, Fragoso YD. 
Systematic review of cognitive dysfunction in pediatric and juvenile multiple sclerosis. 
Pediatr Neurol. 2015 Oct;53(4):287-92. Epub 2015 Jun 18. 
Abstract

Ghezzi A, Moiola L, Pozzilli C, et al. 
Natalizumab in the pediatric MS population: results of the Italian registry. 
BMC Neurol. 2015 Sep 25;15(1):174. 
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Pathophysiology

Fitzner B, Hecker M, Zettl UK.
Molecular biomarkers in cerebrospinal fluid of multiple sclerosis patients. 
Autoimmun Rev. 2015 Oct;14(10):903-13. Epub 2015 Jun 10. 
Abstract

Physical activity

Bowser B, O'Rourke S, Brown CN, et al. 
Sit-to-stand biomechanics of individuals with multiple sclerosis. 
Clin Biomech (Bristol, Avon). 2015 Oct;30(8):788-94. Epub 2015 Jun 25.
Abstract

Hubbard EA, Motl RW, Manns PJ. 
The descriptive epidemiology of daily sitting time as a sedentary behavior in multiple sclerosis.
Disabil Health J. 2015 Oct;8(4):594-601. Epub 2015 Jun 26. 
Abstract

Kantele S, Karinkanta S, Sievänen H. 
Effects of long-term whole-body vibration training on mobility in patients with multiple sclerosis: a meta-analysis of randomized controlled trials. 
J Neurol Sci. 2015 Sep 25. [Epub ahead of print]
Abstract

Pau M, Coghe G, Corona F, et al. 
Effect of spasticity on kinematics of gait and muscular activation in people with multiple sclerosis. 
J Neurol Sci. 2015 Sep 18. [Epub ahead of print] 
Abstract 

Wens I, Dalgas U, Vandenabeele F, et al. 
High intensity exercise in multiple sclerosis: effects on muscle contractile characteristics and exercise capacity, a randomised controlled trial. 
PLoS One. 2015 Sep 29;10(9):e0133697. eCollection 2015. 
Abstract 
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Pregnancy and childbirth

Pozzilli C, Pugliatti M. 
An overview of pregnancy-related issues in patients with multiple sclerosis.
Eur J Neurol. 2015 Oct;22 Suppl 2:34-9. 
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Fragoso YD, Adoni T, Alves-Leon SV, et al. 
Postpartum treatment with immunoglobulin does not prevent relapses of multiple sclerosis in the mother. 
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Prognosis

Damasceno A, Damasceno BP, Cendes F. 
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Wattjes MP, Steenwijk MD, Stangel M. 
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Provision of care

Ponzio M, Tacchino A, Zaratin P, et al. 
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Probasco JC, Hawley G, Burnett M, et al. 
Facilitating early-in-day discharge for multiple sclerosis patients treated with intravenous methylprednisolone: a quality improvement project. 
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Psychological aspects

Sundgren M, Wahlin Å, Maurex L, Brismar T. 
Event related potential and response time give evidence for a physiological reserve in cognitive functioning in relapsing-remitting multiple sclerosis
J Neurol Sci. 2015 Sep 15;356(1-2):107-12. Epub 2015 Jun 16. 
Abstract 

Muñoz San José A, Oreja-Guevara C, Cebolla Lorenzo S, et al. 
Psychotherapeutic and psychosocial interventions for managing stress in multiple sclerosis: the contribution of mindfulness-based interventions.
Neurologia. 2015 Sep 15. [Epub ahead of print] English, Spanish. 
Abstract 

Quality of life

Lysandropoulos AP, Havrdova E. 
'Hidden' factors influencing quality of life in patients with multiple sclerosis. 
Eur J Neurol. 2015 Oct;22 Suppl 2:28-33.
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Rehabilitation

Davies BL, Arpin DJ, Volkman KG, et al. 
Neurorehabilitation strategies focusing on ankle control improve mobility and posture in persons with multiple sclerosis. 
J Neurol Phys Ther. 2015 Oct;39(4):225-32.
Abstract

Review

Ziemssen T, Rauer S, Stadelmann C, 
Evaluation of study and patient characteristics of clinical studies in primary progressive multiple sclerosis: a systematic review. 
PLoS One. 2015 Sep 22;10(9):e0138243. eCollection 2015. 
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Symptoms and symptom management

Keune PM, Cocks AJ, Young WR, et al. 
Dynamic walking features and improved walking performance in multiple sclerosis patients treated with fampridine (4-aminopyridine). 
BMC Neurol. 2015 Sep 24;15(1):171. 
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Miller L, van Wijck F, Lamont L, et al. 
Sensory dynamic orthoses in mild to moderate upper limb tremor in multiple sclerosis: A mixed methods feasibility study. 
Clin Rehabil. 2015 Sep 22. [Epub ahead of print] 
Abstract

Lo AC, Ruiz JA, Koenig CM, et al. 
Effects of dalfampridine on multi-dimensional aspects of gait and dexterity in multiple sclerosis among timed walk responders and non-responders. 
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Abstract 

Vitamin D

Røsjø E, Steffensen LH, Jørgensen L, 
Vitamin D supplementation and systemic inflammation in relapsing-remitting multiple sclerosis. 
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Abstract

Work

Ponzio M, Brichetto G, Zaratin P, Battaglia MA. 
Workers with disability: the case of multiple sclerosis. 
Neurol Sci. 2015 Oct;36(10):1835-41. Epub 2015 May 28. 
Abstract

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