Brodalumab (EU: Kyntheum, U.S.: Siliq) for the treatment of psoriasis

Introduction

Brodalumab (trade name EU: Kyntheum, U.S.: Siliq) has been approved in Germany since July 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 creams or ointments. Treatment with UV light (phototherapy) is an option for people with severe psoriasis. There are also drugs designed to slow down or stop the inflammatory process in different ways. These drugs 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 therapy.

Brodalumab aims to decrease the inflammation in the skin by inhibiting several chemical messengers.

Application

Brodalumab is available in ready-to-use syringes at a dose of 210 mg.

The drug is injected under the skin once a week during the first three weeks of treatment, and then every two weeks. Patients can inject themselves after being instructed how to do so by a doctor.

The success of the treatment needs to be assessed regularly. If there is no improvement after 16 to 20 weeks, stopping the treatment is usually recommended.

Other treatments

For people with moderate to severe plaque psoriasis who are able to have systemic therapy, the drugs fumaric acid ester, ciclosporin, methotrexate or secukinumab are available.

Treatment with adalimumab, infliximab, ustekinumab or secukinumab is an option for patients who have had unsuccessful systemic treatment or for whom it isn't an option.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of brodalumab compared with the standard treatments for people with moderate to severe plaque psoriasis who are able to have systemic treatment.

The manufacturer provided two studies involving a total of 494 people. These were all patients who had had different, unsuccessful systemic treatment before or who weren't able to have systemic treatment.

In the studies, one group of participants (314 people) had the standard treatment with ustekinumab, while the other group (180 people) had treatment with brodalumab. For these patients, the following results were found after 52 weeks.

What are the advantages of brodalumab?

  • Complete remission of psoriasis: The studies suggest that brodalumab has an advantage compared with ustekinumab. With ustekinumab, the skin almost went away completely (at least temporarily) in about 20 out of 100 people. With brodalumab, this was the case in about 50 out of 100 people. The manufacturer did not provide any suitable data on how the treatments influence nail psoriasis.
  • Symptoms: According to initial analyses, treatment with brodalumab seems to have some advantages for patients under the age of 65 in terms of self-reported symptoms.
  • Health-related quality of life: According to initial analyses, the studies suggest that brodalumab has an advantage here. At the end of the study, about 52 out of 100 people who had had treatment with brodalumab reported that the disease no longer affected their quality of life. This was the case for about 34 out of 100 people who had treatment with ustekinumab.

No difference

  • Life expectancy: Very few patients passed away in either group.
  • Treatment stopped due to side effects: There were no differences between the treatments here. About 1 to 4 out of 100 people stopped their treatment because of side effects.

What remains unanswered?

  • Severe side effects: It isn't possible to assess whether there were any differences between brodalumab and ustekinumab here.
  • The manufacturer didn't provide any suitable data on individual side effects such as infections.

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of brodalumab (EU: Kyntheum, U.S.: Siliq).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Brodalumab (EU: Kyntheum, U.S.: Siliq) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A17-42. November 29, 2017. (IQWiG reports; Volume 565).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Updated on March 22, 2018
Next planned update: 2021

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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