Introduction

Risankizumab (trade name: Skyrizi) has been approved in Germany since April 2019 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. It comes and goes 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 creams or ointments. Treatment with UV light (phototherapy) is an option for people with severe psoriasis. There are also medications designed to slow down or stop the inflammatory process in different ways. They can either be taken as tablets or injected into the bloodstream. Treatment with drugs that have an effect on the entire body is called systemic treatment. Basic treatment includes conventional disease-modifying drugs such as methotrexate or fumaric acid esters. If these are no longer effective enough or are not an option, medications produced using biotechnology (biological drugs, or biologics) can be used instead.

The antibody risankizumab is used to decrease the inflammation in the skin by inhibiting several chemical messengers.

Application

Risankizumab is available in 75 mg pre-filled syringes. Two doses (150 mg in total) are injected under the skin.

After the initial injection, the treatment is repeated one month later. After that, risankizumab is used every three months. Patients can also inject themselves after being instructed how to do so by a doctor.

If there is no improvement after about 4 months, doctors usually recommend stopping the treatment.

Other treatments

People with moderate to severe plaque psoriasis who can’t have conventional treatments and will have treatment with biologics for the first time have several treatment options, including adalimumab, guselkumab, ixekizumab and secukinumab.

People who have already had systemic treatment – but for whom it didn’t work well enough or wasn’t well tolerated – can also use adalimumab, guselkumab, ixekizumab, secukinumab, infliximab or ustekinumab, depending on what treatment was tried before.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of risankizumab compared with the standard treatments for moderate to severe plaque psoriasis in adults.

The manufacturer provided two studies for patients who had a previous treatment that didn't work well enough or wasn't well tolerated. A total of 260 people took part in the study. 190 of them had treatment with risankizumab, and 70 were given ustekinumab. After one year, the following results were found for these people:

What are the advantages of risankizumab?

  • Complete remission of psoriasis: The studies show that risankizumab has an advantage here: About 63 out of 100 people who used risankizumab had no symptoms after one year. This was the case for about 23 out of 100 people who had treatment with ustekinumab.
  • Itching, pain and burning: The studies showed that risankizumab has an advantage in terms of these psoriasis symptoms in people between the ages of 40 and 64 years. There was no such difference in younger or older patients.
  • Redness: The studies showed that risankizumab has an advantage here in people who had already had treatment with other biologics. There was no difference in other groups of people in the studies.
  • Scalp free of psoriasis: The studies suggest that risankizumab has an advantage here, too: About 83 out of 100 people who used risankizumab had no psoriasis on their scalp. This was the case for about 56 out of 100 people who had treatment with ustekinumab.
  • General health: Here the studies showed that risankizumab has an advantage for men only. They rated their general health as better than the men who used ustekinumab did. There was no such difference in women.
  • Health-related quality of life: Here too, the study suggested that risankizumab has an advantage compared with ustekinumab. Risankizumab improved quality of life in 76 out of 100 people. That was the case for about 52 out of 100 people who had treatment with ustekinumab.

What are the disadvantages of risankizumab?

Risankizumab was found to have no disadvantages compared to ustekinumab.

No difference

There was no difference between risankizumab and ustekinumab in terms of serious side effects, treatment stopped due to side effects, infections and parasitic diseases.

What remains unanswered?

The manufacturer didn't provide any suitable data concerning things like scaly or cracked skin, bleeding, or the absence of psoriasis on the hands, feet and fingernails.

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 risankizumab (Skyrizi).