Dupixent
Authorised
This medicine is authorised for use in the European Union
dupilumab
MedicineHumanAuthorised
Overview
Dupixent is a medicine used to treat:
- moderate to severe atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry) in patients aged 12 years and over when treatments applied to the skin are not sufficient or appropriate. Patients from 6 months up to 12 years of age can also be given the medicine if their condition is severe.
- severe asthma in patients aged 6 years and over, whose asthma is not properly controlled by appropriate combination therapy (corticosteroids taken by inhalation plus another medicine used for the prevention of asthma). Dupixent is added to maintenance treatment and is only for use in patients with a type of inflammation of the airways called ‘type 2 inflammation’.
- inflammation of the nose and sinuses together with growths (polyps) obstructing the airways in the nose (chronic rhinosinusitis with nasal polyposis). It is used in adults added to local treatment with corticosteroids when other treatments have not worked well enough.
- moderate-to-severe prurigo nodularis (a long-term skin disease with a rash causing lumps with intense itching) in adults. It is used with or without topical (applied to the skin) corticosteroids.
- eosinophilic oesophagitis (an allergic condition of the food pipe) in adults and children above 12 years of age who cannot take conventional treatment or for whom it is not working.
Dupixent contains the active substance dupilumab.
Dupixent is available as pre-filled pens or syringes of various strengths containing dupilumab in a solution for injection under the skin, usually in the thigh or belly. Higher doses are given as 2 injections in 2 different sites. The dose depends on the patient’s age and weight, and the condition being treated.
Dupixent can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of the conditions Dupixent is used to treat. Patients or their carers may inject the medicine themselves if their doctor or nurse considers it appropriate and once they have been trained to do so. The medicine is for long-term use and the need to continue taking the medicine should be assessed by the doctor at least yearly.
Dupilumab can be used with or without topical corticosteroids.
For more information about using Dupixent, see the package leaflet or contact your doctor or pharmacist.
Patients with atopic dermatitis, some types of asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis and eosinophilic oesophagitis produce high levels of proteins called interleukin 4 and interleukin 13 (IL-4 and IL-13), which can cause inflammation of the skin,airways and oesophagus leading to the symptoms of these diseases. The active substance in Dupixent, dupilumab, is a monoclonal antibody (a type of protein) designed to block receptors (targets) for IL-4 and IL-13. By blocking the receptors, dupilumab prevents IL-4 and IL-13 from working and relieves disease symptoms.
Atopic dermatitis
Dupixent was more effective than placebo (a dummy treatment) at reducing the extent and severity of atopic dermatitis in 3 main studies in adults with moderate to severe disease. In the first study, which involved 740 patients, participants were given Dupixent or placebo, both in combination with a topical corticosteroid (a medicine for inflammation applied to the skin). Dupixent or placebo was used on its own in the other two studies involving a total of 1,379 patients.
After 16 weeks of treatment, 39% of patients treated with Dupixent every two weeks in the first study showed clearing or almost clearing of their atopic dermatitis compared with 12% of patients on placebo. Taking the results of the other two studies together, 37% of patients treated with Dupixent every two weeks had clearing or almost clearing of their atopic dermatitis compared with 9% of patients on placebo.
A study was also carried out in 251 adolescents aged from 12 to less than 18 years with moderate to severe atopic dermatitis. In this study, after 16 weeks atopic dermatitis had cleared up or almost cleared up in around 24% of those given Dupixent every 2 weeks compared with around 2% of those given placebo.
A further study looked at 367 children between 6 and 12 years of age with severe atopic dermatitis in whom medicines applied to the skin had proved insufficient or were unsuitable. After 16 weeks, measures of severity showed that atopic dermatitis had cleared up or almost cleared up in around 33% of those given Dupixent with a topical corticosteroid compared with around 11% of those given placebo with a corticosteroid.
In addition, a study involving children between 6 months and less than 6 years of age with moderate to severe dermatitis showed that a 16-week treatment with Dupixent and a topical corticosteroid led to skin clearing in 28% of patients (23 out of 83 patients) compared with 4% of patients (3 out of 79 patients) given placebo and a topical corticosteroid. Overall 53% of patients (44 out of 83 patients) treated with Dupixent and a corticosteroid had an improvement in their skin of at least 75% compared with at least 11% (8 out of 11 patients) with placebo and a corticosteroid.
Asthma
Dupixent was shown to reduce the number of exacerbations (flare-ups) of asthma during treatment in 2 main studies involving patients with asthma that was not adequately controlled by a combination of high-dose inhaled corticosteroids and other medicines. In the first study, involving 1,902 patients aged 12 years or above, the number of severe flare-ups per year was 0.46 in patients taking 200 mg Dupixent and 0.52 in patients taking 300 mg Dupixent, compared with 0.87 or 0.97 in patients given placebo. After 12 weeks of treatment, Dupixent improved patients’ FEV1 (the maximum volume of air a person can breathe out in one second) by 320 ml (for 200 mg Dupixent) or 340 ml (for 300 mg Dupixent) compared with 180 ml and 210 ml for placebo.
The second study, involving 210 patients taking corticosteroids by mouth for their asthma, showed that in 70% of patients given Dupixent their condition improved to the extent that they could reduce their corticosteroid dose compared with 42% of those given placebo.
A subsequent third study involved 408 children 6 to 11 years of age with severe asthma that was not adequately controlled by a combination of medium-to-high-dose inhaled corticosteroids and other medicines. It showed that the number of severe flare-ups of asthma per year was 0.31 in those with type 2 inflammation given Dupixent compared with 0.75 in similar children given a dummy treatment. After 12 weeks of treatment Dupixent improved patients’ predicted FEV1 by 10.5% compared with 5.3% in those given placebo.
Chronic rhinosinusitis with nasal polyposis
Adding Dupixent to treatment with a corticosteroid nasal spray has been shown to improve symptoms of the condition more than placebo in 2 main studies as measured by scoring systems for the extent of nasal polyps and patients’ perception of nasal congestion. In the first study, involving 276 adults, after around 6 months nasal polyp score fell by 1.89 with Dupixent and increased by 0.17 with placebo. Similarly, patients’ score for nasal congestion fell by 1.34 with Dupixent versus 0.45 with placebo. In the second study, involving 448 adults, the polyp score fell by 1.71 with Dupixent and increased by 0.10 with placebo, and the congestion score fell by 1.25 versus 0.38, respectively.
Prurigo nodularis
Dupixent was more effective than placebo at reducing the extent and severity of itching caused by prurigo nodularis in 2 main studies involving a total of 311 adults with moderate to severe disease. The studies measured improvements in symptoms of itching using the Worst Itch Numeric Rating Scale (WI-NRS).
After 24 weeks of treatment, 59% of patients treated with Dupixent had a significant improvement in their symptoms (as measured by a reduction of at least 4 points in the WI-NRS) compared with 19% of patients on placebo.
Eosinophilic oesophagitis
In a study of 321 patients with eosinophilic oesophagitis, Dupixent was more effective than placebo in reducing oesophageal inflammation. In this study, more patients treated with Dupixent treatment had low levels of eosinophils in their blood (a sign of reduced inflammation) compared with patients who had placebo. Patients treated with Dupixent treatment also had greater improvements in their symptom scores for swallowing difficulties
The most common side effects with Dupixent (which may affect up to 1 in 10 people) are injection-site reactions (such as redness, swelling including due to fluid build-up, itching and pain), conjunctivitis (redness and discomfort in the eye) including conjunctivitis due to allergy, joint pain, cold sores and increased blood levels of a type of white blood cell called eosinophils. In eosinophilia oesophagitis patients also had injection site bruising.
There have been very rare cases of serum sickness (allergy to the proteins in the medicine) and serum sickness-like reactions, anaphylaxis (sudden, severe allergic reactions) and ulcerative keratitis (inflammation and damage to the clear layer at the front of the eye).
For the full list of side effects and restrictions of Dupixent, see the package leaflet.
Dupixent has been shown to reduce the extent and severity of atopic dermatitis and prurigo nodularis in patients with moderate to severe disease, for whom available therapies are limited. Similarly, in chronic rhinosinusitis with nasal polyposis, Dupixent produced clinically meaningful improvements in symptoms. In the treatment of type 2 inflammatory asthma, Dupixent has been shown to reduce the number of asthma flare-ups and the need for oral corticosteroid treatment. In the treatment of eosinophilic oesophagitis, Dupixent has been shown to reduce eosinophilic inflammation. Regarding safety, Dupixent’s side effects are generally mild and manageable.
The European Medicines Agency therefore decided that Dupixent’s benefits are greater than its risks and it can be authorised in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dupixent have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Dupixent are continuously monitored. Side effects reported with Dupixent are carefully evaluated and any necessary action taken to protect patients.
Dupixent received a marketing authorisation valid throughout the EU on 27 September 2017.
Product information
Latest procedure affecting product information: IA/0085
08/04/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Dupixent
- Active substance
- dupilumab
- International non-proprietary name (INN) or common name
- dupilumab
- Therapeutic area (MeSH)
- Dermatitis, Atopic
- Prurigo
- Esophageal Diseases
- Asthma
- Sinusitis
- Anatomical therapeutic chemical (ATC) code
- D11AH05
Pharmacotherapeutic group
Agents for dermatitis, excluding corticosteroidsTherapeutic indication
Atopic dermatitis
Adults and adolescents
Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
Children 6 months to 11 years of age
Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy.
Asthma
Adults and adolescents
Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Children 6 to 11 years of age
Dupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Chronic rhinosinusitis with nasal polyposis (CRSwNP)
Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
Prurigo Nodularis (PN)
Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
Eosinophilic esophagitis (EoE)
Dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.
Assessment history
News on Dupixent
Topics
This page was last updated on