Dupilumab (Dupixent) for the treatment of chronic rhinosinusitis with nasal polyps

Introduction

Dupilumab (trade name: Dupixent) has been approved in Germany since October 2019 for the treatment of severe chronic rhinosinusitis with nasal in adults. It is used as an additional treatment to steroid nasal sprays. It is an option if the use of steroid tablets or surgery have not been effective enough.

Rhinosinusitis is the medical term for of the lining of the nose and the paranasal sinuses, which may be caused by an , for instance. The typical symptoms include a stuffy (blocked) or runny nose, a cough, fever and pain (especially in the sinus area).

This may be acute or chronic (lasting for more than three months).

If rhinosinusitis becomes chronic, may form. These are benign growths in the mucous lining of the paranasal sinuses. They obstruct the passage of air through the paranasal sinuses even more and make it easier for germs to settle there.

Treatment with dupilumab aims to reduce the inflammation in the mucus lining by inhibiting a chemical messenger that promotes .

Application

Dupilumab is available as a 300 mg ready-to-use syringe. It is used in addition to steroid nasal sprays (as an “add-on treatment”).

The first time it is used, 300 mg of the medication is injected under the skin (one 300 mg injection). This injection is then repeated every 2 weeks.

Patients can also inject themselves after being instructed how to do so by a doctor.

The effectiveness of the treatment should be monitored regularly. If the symptoms don’t improve after 24 weeks, doctors usually recommend stopping the treatment.

Other treatments

If treatment with steroid tablets or surgery hasn’t been effective enough, the standard treatment for chronic rhinosinusitis with nasal is a steroid nasal spray containing budesonide or mometasone furoate. The treatment may be enhanced by taking measures such as nasal irrigation (flushing out the nose).

Assessment

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of dupilumab compared to the standard treatments for chronic rhinosinusitis with nasal when steroid tablets or a surgical procedure have not been effective enough.

The manufacturer provided two studies for this assessment, and it was possible to analyze the results of the studies together: A total of 438 participants received dupilumab in addition to the standard treatment mometasone furoate, while 286 participants were given a standard treatment consisting of mometasone furoate and a placebo (fake medication).

After half a year, the study showed the following:

What are the advantages of dupilumab?

Symptoms of the illness and their effects: In the studies the patients were asked whether they experienced various symptoms of the illness and problems such as impaired sense of taste, dizziness, pain and trouble sleeping or concentrating, as well as how much of a burden they are. The study showed that dupilumab has an overall advantage here: The symptoms improved in 80 out of 100 people who also received dupilumab, compared to only 54 out of 100 people who were not given dupilumab.

The study also shows that dupilumab has an advantage regarding individual symptoms of the illness, such as a runny or stuffy nose and an impaired sense of smell.

Overall health: The patients were asked how they themselves would rate their overall health. The study shows that dupilumab has an advantage here too.

What are the disadvantages of dupilumab?

Dupilumab wasn’t found to have any disadvantages when used as an add-on treatment.

What remains unanswered?

Health-related quality of life: There was no data on health-related quality of life.

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).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Dupilumab (chronic rhinosinusitis with nasal polyposis) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A19-96. February 27, 2020. (IQWiG reports; Volume 890).

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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Created on April 9, 2020
Next planned update: 2023

Authors/Publishers:

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

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