Issue 38 / 10 October 2011

A NEW generation of drugs for treating multiple sclerosis is showing promise internationally, increasing possible effective management options for individual patients.

A randomised trial involving 1088 patients recruited from 127 centres in 21 countries found that teriflunomide, an oral disease-modifying therapy for relapsing forms of MS, significantly reduced relapse rates, disability progression and magnetic resonance imaging-based evidence of disease activity, compared with placebo.

Researchers writing in the New England Journal of Medicine said the results of the phase 3 study suggested teriflunomide was an effective new oral monotherapy for relapsing MS. (1)

Patients, aged 18 to 55 years, were randomly assigned to received either placebo, 7 mg of teriflunomide or 14 mg of teriflunomide once daily for 108 weeks.

The drug was shown to reduce relapses irrespective of dose. Those in both teriflunomide groups had a relative risk reduction in the annualised relapse rate of about 31% compared with those in the placebo group.

Professor Bill Carroll, MS researcher and head of the neurology department at Sir Charles Gairdner Hospital, welcomed the new research.

“Anything that stops or slows MS is exciting. And all of the drugs that we have available in Australia now and these ones that are in the pipeline or on the horizon, looking as though they are going to be beneficial, are also exciting.”

“Multiple sclerosis is a chronic, disabling, crippling disease affecting young people, young adults, often in the prime of their lives with families and careers”, said Professor Carroll, who is also chairman of the MS Research Australia research management council.

A separate systematic review published in the Cochrane Library last week found that MS patients in remission who took the new generation anti-inflammatory drug natalizumab for 2 years had lower relapse and disability progression rates. (2)

In the review of three trials involving more than 2000 patients, natalizumab was shown to reduce the risk of experiencing at least one new exacerbation at 2 years by about 40% and of experiencing progression at 2 years by about 25%, compared to a control group.

While natalizumab is available in Australia, teriflunomide is not currently used.

The Cochrane data showed “excellent figures” for natalizumab and patients and doctors were “extremely satisfied” with its efficacy so far, Professor Carroll said.

However, he said that natalizumab was being watched closely because it was linked to progressive multifocal leukoencephalopathy, a viral infection of the brain, with about 159 cases worldwide.

“This drug is the most scrutinised drug almost ever introduced into Europe, America and Australia”, Professor Carroll said.

“Every patient has to have the drug administered in an accredited infusion centre, and every neurologist in Australia who uses it has to have been accredited to do so.”

Professor Carroll said there were an increasing number of effective MS drugs that gave doctors and patients a choice of treatments best suited to their individual patients’ needs.

“Multiple sclerosis is not a condition for which one drug fits everybody very well”, he said.

“The more choice and the more variation in effective treatments, the better.”

-Linda McSweeny

1. N Engl J Med 2011; 365:1293-303

2. Cochrane Library 2011; 5 October (online)

Posted 10 October 2011

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