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In the news - July 2006

Way Ahead 2006;10(3):3,8,15
  1. IV steroids – home or away?
  2. FDA approves reintroduction of Tysabri
  3. Tysabri approval in Europe moves closer
  4. Stem cells: clinics under Investigation
  5. Testosterone gel may have benefits in men with MS
  6. FTY720: extension study results reported
  7. Paediatric MS: consensus definition proposed
  8. Sharing practice

1. IV steroids – home or away?

Treatment of relapses in multiple sclerosis with intravenous steroids can be effectively and safely administered at home, according to the results of a trial published online in the Lancet Neurology.

Intravenous (IV) steroids are routinely used to treat disabling relapses in multiple sclerosis, and can be administered in an out-patient or home setting. However the two strategies have not been compared formally in a trial setting.

An appropriate rating scale, measuring patients' experiences of relapse management was developed as the primary outcome measure. A randomised controlled trial of outpatient versus home treatment was performed in patients having a clinically significant relapse within four weeks of onset. The efficacies of the two treatment methods were compared in terms of traditional measures, and economic cost.

Of 149 eligible patients, 138 consented to the trial and were randomised into the two arms. The home treatment group had a significantly better patient experience of relapse management in terms of co-ordination of care which took into account the comfort of the setting and convenience. Steroids were equally safe and effective in either location and cost was either the same or cheaper when delivered at home than when in hospital.

In the treatment of relapses, there is now good evidence for intravenous steroids to be given at home, from both patient and economic perspectives. Moreover the trial demonstrates the importance of an explicit and valid outcome measure which reflects all aspects of service delivery when making decisions on health policy. This has implications for complex service delivery care models in long-term conditions.

The MS Trust is delighted to have funded this important study. It shows that rapid and effective access to treatment in relapse is critical and it puts patient choice at the centre of the decision about relapse care. By demonstrating the potential for NHS cost savings, we hope that in time this research will translate into development of services that offer real choice for people with MS.

Reference
Chataway J, Porter B, Riazi A, et al.
Home versus outpatient administration of intravenous steroids for multiplesclerosis relapses: a randomised controlled trial.
Lancet Neurol 2006 May 17; [Epub ahead of print]

A summary of the article can be read on the Lancet website (requires free registration).

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2. FDA approves reintroduction of Tysabri

On 5 June, the US Food and Drug Administration (FDA) approved an application for Tysabri to return to the market for relapsing/remitting MS. Tysabri has been authorised for use as a monotherapy in patients who have failed to respond to, or are unable to tolerate, other MS therapies. The approval is subject to a special restricted distribution programme.

TOUCH Prescribing Program
In response to an Advisory Committee recommendation, Biogen Idec submitted a Risk Management Plan, called the TOUCH (Tysabri Outreach: Unified Commitment to Health) Prescribing Program to the FDA, to help ensure safe use of the product and assess the incidence and risk factors for opportunistic infections associated with Tysabri treatment.

Tysabri will only be available under the TOUCH Program, elements of which include:

  • revised labelling, including a prominent warning of PML;
  • mandatory enrolment for all prescribers, central pharmacies, infusion centres and patients;
  • patient evaluation at 3 and 6 months after the first infusion and 6-monthly thereafter;
  • a 5000 patient cohort observational study over five years.

Biogen Idec and Elan Corporation anticipate that Tysabri will be available in the US in July. Data has also been submitted to the European Medicines Agency (EMEA) for a licence application. A decision from the European Commission is expected by the summer.

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3. Tysabri approval in Europe moves closer

On 28 April, it was announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), recommended that Tysabri be authorised for use as a single disease modifying therapy in people with highly active relapsing/remitting MS who have failed to respond to treatment with beta interferon, or in patients who have rapidly evolving severe relapsing/remitting MS. The final decision will be made by the European Commission, which grants final marketing approval for all centrally reviewed medicinal products that are to be introduced in the EU market. It is anticipated a decision will be made by the summer.

Source: EMEA press release

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4. Stem cells: clinics under investigation

The doctor who runs a clinic in Cork that has been facilitating stem cell treatments from Advanced Cell Therapeutics (ACT) is currently being investigated by the Irish Medical Council (the equivalent of the GMC in the UK) after the Irish Medicines Board acted to stop the treatments. ACT has been supplying umbilical cord blood stem cells to numerous clinics around the world. A second clinic in Rotterdam is also under investigation by the Dutch authorities following complaints from Dutch neurologists. The Dutch healthcare inspectorate is concerned that the clinic has not applied for ethical approval for its experimental work on humans. However, the clinic has been allowed to stay open during the investigation.

Source: The Guardian

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5. Testosterone gel may have benefits in men with MS

Results of a small study in 10 men with relapsing/remitting MS were reported at the American Academy of Neurology meeting. Following a six-month observation period, the men were all treated with 100mg of testosterone gel (applied to the skin) daily for six months. Pre- and post-treatment measures were then compared. Clinical disease measures remained stable, but a significant improvement was seen in cognitive function. There was also an increase in the production of brain-derived neurotrophic factor, a protein that promotes nerve cell survival. It was also observed that the rate of brain atrophy was slowed. No adverse treatment effects were reported.

Source: AAN press release

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6. FTY720: extension study results reported

Results from a six-month extension of the phase II trial of oral FTY720, or Fingolimod (Novartis), were reported at the American Academy of Neurology Meeting in April. All patients in the treatment groups continued on their original dose (1.25mg or 5mg), whilst patients in the placebo group were allocated to receive either 1.25mg or 5mg of FTY720. 227 people completed the extension study. Relapse rate was reduced by 70% in placebo group patients switched to 1.25mg. In those switched to 5mg, relapse rate was reduced by 86%. A significant reduction in active inflammation, as measured by MRI, was seen in both groups formerly on placebo. Relapse rate and active inflammation remained low in both groups continuing on FTY720. However, there was a higher incidence of adverse effects (eg infections, increased blood pressure and altered liver function tests) in the 5mg groups. A phase III study FREEDOMS (Fingolimod Research Evaluating Effects of Daily Oral therapy in Multiple Sclerosis) is now underway in Europe. Participants will be equally randomised to receive either 1.25 mg or 0.5 mg of FTY720 or placebo once daily for up to 24 months.

Source: Medical News Today

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7. Paediatric MS: consensus definition proposed

The International Paediatric MS study group, chaired by Prof. Lauren Krupp, have reached a consensus on proposed definitions for a range of childhood neurological disorders, including paediatric MS. These definitions should enable doctors to differentiate between several paediatric neurological disorders that can have overlapping features and often mimic each other. It is also hoped that the definitions will improve communication about conditions such as paediatric MS and acute disseminated encephalomyelitis (ADEM) and encourage research to validate and enhance the definitions. The definitions have not yet appeared in print, but as soon as they become available the MS Trust will circulate them via our website.

Source: National MS Society

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8. Sharing practice

"If I have seen further it is by standing on the shoulders of giants." Isaac Newton, Letter to Robert Hooke, February 5, 1675

Are you working towards creating an MS Care Pathway, or preparing a protocol for use of steroids within your PCT? Many nurses and health care professionals are working in these and other important areas in line with the National Service Framework for Long-term Conditions to ensure the best service for their clients with MS, but is this something another group may have done already? This issue of Way Ahead features an article on relapse management by Alan Izat et al, and Ros Edwards and Annette Leach have produced an MS Care Pathway that we will be featuring in a future edition.

Why reinvent the wheel?

A number of people are working on developing protocols or care pathways, are you? Do you have any examples of service user satisfaction questionnaires, service audit or local assessment measures? We would be delighted to publish your work. Are you working on a project and would like to tap into other peoples experience? Or do you have something else you would like to share? Let us know and, either in Way Ahead and/or via the website, we will reach your colleagues.

Contact the MS Trust Information Team on 01462 476703; or email: infoteam@mstrust.org.uk

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