Skyrizi

Skyrizi can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating plaque psoriasis.

Skyrizi is available in pre-filled syringes. It is injected under the skin in an area that is clear of psoriasis, usually in the thighs or belly. The recommended dose is 150 mg (2 injections). The first two doses of 150 mg are given 4 weeks apart while subsequent doses are given every 12 weeks.

The doctor may decide to stop treatment if the condition does not improve after 16 weeks. After being trained, patients may inject Skyrizi themselves if the doctor considers it appropriate.

For more information about using Skyrizi, see the package leaflet or contact your doctor or pharmacist.

The active substance in Skyrizi, risankizumab, is a monoclonal antibody (a type of protein) that is designed to attach to interleukin 23 and block its activity. Interleukin 23 is a messenger molecule of the body's immune system (the body's natural defences) and is involved in causing inflammation that is linked to the formation of plaque psoriasis. By blocking the action of interleukin 23, risankizumab reduces inflammation and symptoms associated with the disease.

In 4 main studies involving over 2,100 patients with moderate to severe disease who required systemic treatment, Skyrizi was more effective than placebo (a dummy treatment) and comparator medicines at improving symptoms.

In the first two studies in a total of 997 patients, after 16 weeks of treatment around 75% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores (a measure of how severe and widespread the skin lesions are), compared with around 45% of those receiving ustekinumab and around 4% of those receiving placebo. In addition, around 86% of patients receiving Skyrizi had clear or almost clear skin, compared with around 62% of those receiving ustekinumab and around 6% of those receiving placebo. Improvements in symptoms were maintained after 52 weeks of treatment with Skyrizi.

In the third study involving 605 patients, after 16 weeks of treatment 72% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores, compared with 47% of those receiving adalimumab. In addition, 84% of patients receiving Skyrizi had clear or almost clear skin, compared with 60% of those receiving adalimumab.

Finally, in the fourth study involving 507 patients, after 16 weeks of treatment 73% of patients receiving Skyrizi had a reduction of at least 90% in PASI scores, compared with 2% of those receiving placebo. Around 84% of patients receiving Skyrizi had clear or almost clear skin, compared with around 7% of those receiving placebo. In a second part of this study, some patients who first received Skyrizi were then switched to placebo after 28 weeks while others remained on Skyrizi. At week 52, more patients who remained on Skyrizi had had clear or almost clear skin than those who were switched to placebo.

The most common side effect with Skyrizi (which may affect more than 1 in 10 people) is upper respiratory infection (nose and throat infection).

Skyrizi must not be used in patients who have an ongoing infection that the doctor considers important.

For the full list of side effects and restrictions, see the package leaflet.

Studies have shown that Skyrizi is highly effective at clearing the skin and the positive effects are maintained with continued use. There are few side effects, the most important one being infection.

The European Medicines Agency therefore decided that Skyrizi’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Skyrizi have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Skyrizi are continuously monitored. Side effects reported with Skyrizi are carefully evaluated and any necessary action taken to protect patients.

Skyrizi received a marketing authorisation valid throughout the EU on 26 April 2019.