Skilarence - Dimethyl fumarate

What is Skilarence - Dimethyl fumarate and what is it used for?

Skilarence is a medicine used to treat plaque psoriasis, a disease that causes thickening, redness and inflammation of parts of the skin with scaly patches. It is used in patients with moderate or severe disease for whom treatments applied directly to the skin are not effective enough.

Skilarence contains the active substance dimethyl fumarate

How is Skilarence used?

Skilarence can only be obtained with a prescription and should be used under the supervision of a doctor experienced in the diagnosis and treatment of psoriasis.

Skilarence is available as tablets (30 and 120 mg). The starting dose is 30 mg once a day and is increased weekly according to the schedule indicated in the package leaflet until the psoriasis starts to subside or until the patient takes the maximum dose of 240 mg three times a day. . The tablets should be swallowed whole during or immediately after a meal. When psoriasis is under control, the doctor can reduce the dose.

For more information, see the package leaflet.

How does Skilarence - Dimethyl fumarate work?

Psoriasis is caused by "excessive activity of the body's immune (defense) system". The active substance in Skilarence, dimethyl fumarate, reduces the activity of the immune system. It is believed to act on T lymphocytes (a type of white blood cell that is part of the immune system) to stop cells from producing substances that cause inflammation and lead to psoriasis .

What benefit has Skilarence - Dimethyl fumarate shown during the studies?

A main study involving 704 patients with moderate to severe plaque psoriasis found that Skilarence was more effective than placebo (a dummy treatment) at treating the disease and was as effective as Fumaderm (a psoriasis medicine containing dimethyl fumarate and monoethyl fumarate) . The main measure of effectiveness was the proportion of patients who achieved a 75% reduction in their disease severity score. After 16 weeks of treatment, 37% of patients taking Skilarence achieved this reduction, compared with 15% of those taking placebo and 40% of those taking Fumaderm.

What are the risks associated with Skilarence - Dimethyl fumarate?

The most common side effects with Skilarence (which may affect more than 1 in 10 people) are effects on the digestive system (diarrhea, bloated stomach, stomach pain and nausea), flushing (reddening of the skin) and low levels of lymphocytes (such as white blood cells) or white blood cells in general. For the full list of side effects reported with Skilarence, see the package leaflet.

Skilarence must not be used in patients with severe digestive, liver or kidney problems. It must also not be used by pregnant or breastfeeding women.

Why has Skilarence - Dimethyl fumarate been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Skilarence's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the main study had shown that it was safe. "short-term effectiveness of Skilarence; in addition, published studies with similar medicines show that efficacy is maintained with continued use. For the most part, side effects are mild or moderate. Since Skilarence reduces the activity of the immune system, there is a risk of serious infections, including including progressive multifocal leukoencephalopathy (PML, a "brain infection); however, this risk can be minimized by periodic analysis of white blood cell counts and, if necessary, by discontinuing treatment.

What measures are being taken to ensure the safe and effective use of Skilarence - Dimethyl fumarate?

The company that markets Skilarence will provide educational material to healthcare professionals about the risk of serious infections, including PML, and how to minimize this risk.

The recommendations and precautions to be observed by healthcare professionals and patients for Skilarence to be used safely and effectively have also been reported in the summary of product characteristics and package leaflet.

More information about Skilarence - Dimethyl fumarate

For the complete version of Skilarence's EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Skilarence therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.


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