Introduction

Dupilumab (trade name: Dupixent) has been approved in Germany since September 2017 for the treatment of moderate to severe eczema in adults who are able to have systemic treatment.

Eczema – also known as atopic eczema or atopic dermatitis – is a chronic (long-lasting), non-infectious skin condition.

Typical symptoms include rashes and severe itching that come and go in episodes. The acute symptoms include red and itchy skin, sometimes with blisters that easily break and then weep (leak liquid). Over time the skin can become dry and cracked, and also thicken.

Adults are most commonly affected on the hollows of their knees, their elbows and the back of their neck. The itchy rash may also occur on their palms and the soles of their feet. It rarely affects the face. Eczema is usually treated with creams or ointments. In severe cases, other options include UV light or what is known as systemic treatment with oral drugs or injections.

Systemic treatment with dupilumab aims to decrease the inflammation in the skin by inhibiting a chemical messenger involved in inflammatory processes.

Application

Dupilumab is available as a pre-filled syringe containing 300 mg. The first injection contains 600 mg of the drug. After that, a 300 mg injection is used 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 weeks, stopping the treatment is usually recommended.

Other treatments

For people with moderate to severe eczema who are able to have systemic treatment, the standard treatment is optimized individual therapy. This treatment will depend on which treatments have been tried before. It is individually adjusted by the doctor. The treatment options include the drugs tacrolimus, glucocorticosteroids, ciclosporin, or treatment with UV light.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether dupilumab has any advantages or disadvantages compared to optimized individual therapy.

The manufacturer provided one suitable study with 425 sets of patient data that could be used in the analysis. Of those patients, 110 used dupilumab for about a year and 315 used a placebo (fake medication). In addition, both groups had treatment with glucocorticoid creams. If their symptoms got worse, the treatment was individually adjusted further. The study included only people who had had moderate to severe eczema for at least three years.

What are the advantages of dupilumab?

  • Itching: The study suggests that dupilumab has an advantage here: Over the course of a year, itching improved in almost 70 out of 100 people who had treatment with dupilumab. In the group that had optimized individual therapy, this only happened in about 37 out of 100 people.
  • Insomnia: In terms of this side effect, initial analyses suggest that dupilumab has an advantage here as well. Sleep problems were less common in people who had treatment with dupilumab than they were in those who had optimized individual therapy.
  • Symptoms: The study suggests that dupilumab had advantages in terms of other symptoms, too: People who used dupilumab experienced fewer symptoms such as itching, dry skin or scaly skin.
  • Health-related quality of life: The study suggests that dupilumab is better than a placebo here: Almost 46 out of 100 people who used dupilumab reported that their quality of life improved, compared to about 18 out of 100 people who had individually optimized treatment.

What are the disadvantages of dupilumab?

  • The study suggests that dupilumab has a disadvantage in terms of eye diseases. These occurred in 30 out of 100 people who used dupilumab, compared to only about 15 out of 100 people who had individually optimized treatment.

No difference

  • Serious side effects: No difference was found here. In both groups, 4 to 6 out of 100 people had severe side effects.
  • No difference was found in terms of the following, either:
    • Treatment stopped due to side effects
    • General health
    • Infections and parasitic diseases

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 dupilumab (Dupixent).