Adtralza

Adtralza is available as a solution for injection under the skin. The first dose is four injections of 150 mg, each into a different location. This is followed by two injections of 150 mg every two weeks. The medicine can only be obtained with a prescription. For more information about using Adtralza, see the package leaflet or contact your doctor or pharmacist.

Patients with atopic dermatitis produce high levels of proteins called interleukin 13 (IL-13), which can cause inflammation of the skin leading to the symptoms of this disease such as redness, swelling and itching. The active substance in Adtralza, tralokinumab, is a type of protein (monoclonal antibody) designed  to neutralise IL-13. By neutralising IL-13, tralokinumab prevents IL-13 from working and thereby reduces the inflammation and patient’s symptoms.

Adtralza was more effective than a placebo (dummy treatment) at reducing the extent and severity of atopic dermatitis after 16 weeks of treatment in three main studies in adult patients with moderate to severe disease that had not responded well enough to treatment applied to the skin. The main measures of effectiveness were having clear or almost clear skin, and a reduction in symptom score of at least 75%.

In the first study, which involved 802 patients, around 16% of patients who received Adtralza had clear skin or almost clear skin compared with 7% of those who received placebo. Symptoms were satisfactorily reduced in 25% of patients who received Adtralza, compared with about 13% of those who received placebo.

In the second study, involving 794 patients, treatment with Adtralza led to clear or almost clear skin in about 22% of patients, compared with around 11% of patients who used a placebo. Symptoms were satisfactorily reduced in 33% of patients receiving Adtralza versus about 11% of those receiving placebo.

In the third study, 380 patients were given Adtralza or placebo, both in combination with a topical corticosteroid (a medicine for inflammation applied to the skin). Adtralza treatment led to clear or almost clear skin in around 39% of patients versus 26% of those receiving placebo. Symptoms were satisfactorily reduced in 56% of the patients who received Adtralza, compared with about 36% of patients on placebo.

In an additional study involving 301 children aged between 12 and 17 years with atopic dermatitis, treatment with Adtralza 300 mg every two weeks for 16 weeks led to clear or almost clear skin in around 18% of patients, while treatment with 150 mg every other week for 16 weeks led to clear or almost clear skin in around 21% of patients. This compared with around 4% of patients who used a placebo.

The most common side effects with Adtralza in adults are upper respiratory tract infections (colds and other infections of the nose and throat) which may affect more than 1 in 10 people. Other common side effects include reactions at the injection site and redness and discomfort in the eye (which may affect up to 1 in 10 people). In children, studies showed that the safety profile is similar to that in adults.

For the full list of side effects and restrictions of Adtralza, see the package leaflet.

Four main studies have shown that Adtralza is effective at clearing the skin and reducing symptoms of atopic dermatitis. The side effects are considered manageable. The European Medicines Agency decided that Adtralza’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adtralza have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Adtralza are continuously monitored. Side effects reported with Adtralza are carefully evaluated and any necessary action taken to protect patients.

Adtralza received a marketing authorisation valid throughout the EU on 17 June 2021.