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Research news - September 2008

Way Ahead 2008;12(4):4


Two new cases of PML reported in EU users of natalizumab
Laquinimod shows promise for relapsing-remitting MS
CUPID study completes recruitment
New formulation of Rebif
National Hospital for Neurology and Neurosurgery forms research partnership

Two new cases of PML reported in EU users of natalizumab

Towards the end of July 2008, two new cases of the potentially lethal brain infection, progressive multifocal leukoencephalopathy (PML), were reported in relapsing-remitting MS patients receiving natalizumab (Tysabri) monotherapy. The first patient had received natalizumab monotherapy for 17 months while the second patient had received natalizumab monotherapy for 14 months. The second patient also had a history of interferon and azathioprine treatment. These two cases do not change the risk profile currently reflected in the drug's license but they are being assessed by the European Medicines Agency (EMEA) who will determine whether the currently approved product information and prescribing recommendations need to be changed.

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Laquinimod shows promise for relapsing-remitting MS

Promising results have emerged out of a phase II study investigating the effect of an oral drug in people with relapsing-remitting multiple sclerosis. The study showed that a 0.6mg daily dose of oral laquinimod significantly reduced MRI disease activity in people with relapsing remitting MS. 306 eligible participants were randomised to receive a two-tablet daily dose of 0.3mg laquinimod; 0.6mg laquinimod; or placebo, over 36 weeks. Compared with placebo, treatment with laquinimod 0.6mg significantly reduced MRI disease activity. The 0.3mg laquinimod dose showed no significant effect over placebo. If the two further phase III trials now underway confirm these positive results, the availability of an oral drug would represent a valuable addition to the currently available disease modifying therapies which are all injectable.

Comi G, Pulizzi A, Rovaris M, et al.
Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, doubleblind, placebo-controlled phase IIb study.
Lancet 2008; 371:2085-2092.

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CUPID study completes recruitment

The MS Trust has welcomed the news that the CUPID (Cannabinoid Use in Progressive Inflammatory brain Disease) study has completed recruitment. The trial, which is investigating the potential role of a cannabis derivative in slowing the progression of multiple sclerosis has recruited 493 participants from 27 sites across the UK. The study completes in 2011 and it is hoped that the results will show firm evidence of the protective effect of the active cannabis compound, tetrahydrocannabinol (THC). If the study demonstrates that THC does have a longer term effect on the progression of disability in MS, it would have far reaching implications for people with the progressive form of MS, for which there is as yet, no other effective treatment. The MS Trust is supporting this research study through contributions to the funding of MRI monitoring of trial participants.

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New formulation of Rebif

Merck Serono has recently launched a new formulation of their interferon beta 1a (Rebif). People taking Rebif should be made aware that this new formulation must be kept at 2-8°C. This means that, unlike the old formulation, it cannot be left out of the refrigerator.

Health professionals should monitor patients switching to the new formulation and report any new side effects experienced by their patients through the NHS yellow card scheme.

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National Hospital for Neurology and Neurosurgery forms research partnership

Four UK hospitals will form a partnership with University College London to create Europe's largest biomedical research organisation. The group, known as 'UCL partners' will concentrate on key areas of research - amongst which are diseases of the nervous system. The participating hospitals include Great Ormond Street Hospital for children, Moorfields Eye Hospital, the Royal Free Hampstead and the University College Hospitals (UCLH) group. The National Hospital for Neurology and Neurosurgery (part of the UCLH group) is a recognised centre of expertise in the treatment of MS and we hope that neurology research will benefit from being part of this partnership.

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