NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Medicines Update

New oral therapies for Multiple Sclerosis

It is exciting times in the treatment of Multiple Sclerosis (MS) with the approval of two new oral therapies for the treatment of the relapsing remitting form of the disease; dimethyl fumarate and teriflunomide. There has been significant media attention and interest from patient groups and clinicians who welcome these new oral therapies. 

 

Dimethyl fumarate and teriflunomide have both been added to the Total Formulary after being accepted by the SMC for the treatment of adults with relapsing remitting multiple sclerosis (RRMS). These will offer an alternative to existing first line therapies, beta-interferon and glatiramer acetate, which are given by injection. The assessment, prescribing and monitoring of these treatments will continue to be undertaken by the specialist regional centre at the Neurological Institute, Southern General Hospital. 

 

Dimethyl fumarate (Tecfidera)

Dimethyl fumarate is accepted for use within NHS Scotland for the treatment of adult patients with RRMS. Two phase 3 clinical trials of dimethyl fumarate have been completed for RRMS, which included more than 2,000 people worldwide. Both studies evaluated the effect of on relapse rate, the progression of disability, and the damage to the brain caused by MS.

 

Dimethyl fumarate is administered orally twice daily and reduces relapse rate by approximately 50%.  Beta-interferon and glatiramer acetate, existing first line therapies, reduce relapse rates by around one-third. Although no direct comparison has been undertaken in a clinical trial setting, this suggests dimethyl fumarate may offer improved efficacy. Clinically relevant effects on disability worsening were also seen, though the trials were only of two years’ duration. The main side effects with dimethyl fumarate are flushing (approximately one third of patients) and gastrointestinal (GI) disturbance (diarrhoea, nausea, upper abdominal pain) which are most common in the first month.  GI side effects can be minimised by taking dimethyl fumarate with food. 

 

Teriflunomide (Aubagio®)

Teriflunomide is accepted for restricted use in RRMS.  Teriflunomide is not expected to be used for the treatment of patients with highly active disease.

 

The clinical trial programme for teriflunomide was similar to that for dimethyl fumarate. Teriflunomide is administered orally once daily and reduces relapse rate by approximately 30%. This suggests a similar effect to beta-interferon or glatiramer acetate, although again direct comparisons have not been made. Clinically relevant effects on disability worsening were also seen, though the trials were only of 2 - 2.5 years’ duration. The main side effects with teriflunomide are nausea, headaches, diarrhoea and hair thinning/loss. Teriflunomide requires fortnightly blood monitoring for the first six months of treatment and a washout procedure is recommended if patients need to discontinue therapy. 

 

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