Sunday, May 3, 2015

Dimethyl fumarate (BG-12) first line oral treatment for people with multiple sclerosis: STUDY


Dimethyl fumarate was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for adults with relapsing-remitting multiple sclerosis (RRMS). It does not require that any other medication be tried before dimethyl fumarate is prescribed. Although data from non Cochrane reviews are available, it is important to systematically evaluate its efficacy and safety as monotherapy versus placebo.

Study characteristics

We searched medical databases for studies in which participants were randomly assigned to dimethyl fumarate or a control drug (randomised controlled trials). The efficacy of this therapy was considered in terms of occurrence of relapses and progression of the disease.

Key results and quality of evidence

We found moderate quality evidence that both dosages of dimethyl fumarate reduce the number of people with RRMS having relapse after two years of treatment, while there is low quality evidence showing that the medicine reduces the number of people who experience worsening disability at the end of two years.

Common adverse effects such as flushing and gastrointestinal events (diarrhoea, nausea and upper abdominal pain) are mild to moderate for most of patients. Dimethyl fumarate can have an effect on the body's immune system by causing a drop in the number of the white blood cells which help to fight infection. More people in the groups treated with dimethyl fumarate experienced this than they did with placebo. We found moderate quality that people were more likely to leave the study early because of adverse events if they were treated with dimethyl fumarate than with placebo.

Authors' conclusions:
There is moderate-quality evidence to support that dimethyl fumarate at a dose of 240 mg orally three times daily or twice daily reduces both the number of patients with a relapse and the annualised relapse rate over two years of treatment in comparison with placebo. However, the quality of the evidence to support the benefit in reducing the number of patients with disability worsening is low. There is no high-quality data available to evaluate the benefit on MRI outcomes. The common adverse effects such as flushing and gastrointestinal events are mild-to-moderate for most patients. Lymphopenia and leukopenia are uncommon adverse events but significantly associated with dimethyl fumarate. Both dosages of dimethyl fumarate have similar benefit and safety profile, which supports the option of low-dose administration. New studies of high quality and long-term follow-up are needed to evaluate the benefit of dimethyl fumarate on prevention of disability worsening and to observe the long-term adverse effects including progressive multifocal leukoencephalopathy.

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