Introduction

Dimethyl fumarate (trade name: Skilarence) has been approved in Germany since June 2017 for the systemic treatment of moderate to severe plaque psoriasis in adults.

Psoriasis is a non-contagious inflammatory skin disease. The symptoms usually include clearly defined red patches (called "plaques"), scaly skin and often itching too. They come and go in bouts: The skin can get better on its own, but it may also suddenly get worse. Psoriasis is a chronic (long-lasting) condition that currently has no cure.

It is usually treated with medications applied directly to the skin (topically), for instance with creams or ointments. Phototherapy is an option for people with more severe psoriasis. There are also drugs designed to decrease or stop the inflammation in different ways. They can either be taken as tablets or injected into the bloodstream. This form of treatment is called systemic treatment.

Dimethyl fumarate aims to decrease the inflammation in the skin.

Application

The drug is available in the form of tablets, in two different doses (30 and 120 mg). The dose should be increased gradually:

  • 30 mg a day during the first week
  • 60 mg a day during the second week
  • 90 mg a day during the third week
  • 120 mg a day during the fourth week
  • From the fifth week on, the dose is increased by 120 mg per week until the maximum daily dose of 720 mg is reached.

The dose can be adjusted depending on intolerances, success of the treatment, or blood values.

Other treatments

For people with moderate to severe plaque psoriasis who are able to have systemic treatment, psoralen plus ultraviolet A therapy (PUVA) is an option, as well as the drugs fumaric acid ester, ciclosporin, methotrexate or secukinumab.

For people who have had unsuccessful systemic treatment with PUVA, ciclosporin or methotrexate, or who can't have these treatments because they are not suitable, treatment with a tumor necrosis factor (TNF) α inhibitor (adalimumab or infliximab), secukinumab or ustekinumab are options.

Assessment

In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into the advantages and disadvantages of dimethyl fumarate compared with the standard treatments for moderate to severe plaque psoriasis in adults.

But the manufacturer did not provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of dimethyl fumarate (Skilarence).