Adbry for Atopic Dermatitis: What You Need to Know

Medically Reviewed by Leah Mueller, PharmD on September 06, 2024
9 min read

If you have atopic dermatitis, a skin condition commonly known as eczema, prescription creams or other topical medicines and moisturizers are usually enough to manage it. However, if your eczema is more severe, widespread, or does not respond well to these treatments, your health care provider may recommend a biologic medicine to better control your symptoms and help improve your quality of life. 

Biologic medicines differ from regular medicines because biologics are made using living cells. They are designed to target specific parts of the immune system to treat inflammatory conditions like atopic dermatitis.

One such biologic medicine for atopic dermatitis is Adbry (tralokinumab), which was approved by the FFDA in 2021. It comes as a liquid solution that is injected under the skin.

Atopic dermatitis (eczema) is a long-lasting skin condition that can make areas of your skin extremely itchy. It also causes rashes that make your skin dry, inflamed, bumpy, scaly, or crusty. You may have flare-ups when your symptoms get worse for days or weeks at a time. In more severe cases, symptoms may disrupt your sleep or daily activities.

Many things are thought to cause atopic dermatitis, such as genetics, a weakened skin barrier, environmental triggers, and an overactive immune response. 

Adbry treats atopic dermatitis by blocking the effects of a protein called interleukin-13 (IL-13). This protein is part of your body’s immune response. Normally, IL-13 triggers your immune system to release substances that lead to inflammation, itchiness, and changes in the skin barrier. Skin areas affected by atopic dermatitis may have higher amounts of IL-13. By blocking the effects of IL-13, Adbry lowers inflammation in your body and can help reduce or clear the symptoms of atopic dermatitis.

Adbry treats atopic dermatitis in adults and some children. The FDA has approved this medicine specifically for the following people:

  • Adults with moderate to severe atopic dermatitis that is not well controlled with prescription medicines applied to the skin (topicals) or when these treatments cannot be used.
  • Children ages 12 and older with moderate to severe atopic dermatitis that is not well controlled with prescription topical medicines or when these treatments cannot be used.  

It is not known if Adbry is a safe or effective treatment in children younger than 12.

Three clinical studies called ECZTRA 1, 2, and 3 were done to test Adbry’s effectiveness for treating atopic dermatitis (eczema) in adults. To see how well Adbry worked, two of the studies compared Adbry to a placebo (a treatment that contains no medicine) and one of the studies compared Adbry to a placebo plus other topical medicines applied to the skin. Researchers also studied Adbry’s safety by collecting information about side effects reported by all participants. 

The main goal for all three studies was to see how many people had clear or almost clear skin after 16 weeks. Researchers also wanted to see if people had reduced symptoms, such as itchiness. 

These studies looked at the effect of Adbry in adults with moderate to severe atopic dermatitis. Everyone who participated in the studies had to meet the following requirements.

  • Everyone in the study had to be 18 or older.
  • Everyone in this study had to have had atopic dermatitis for at least 1 year before the study began. 
  • Everyone had to be eligible for systemic therapy (treatment that affects the whole body). People were eligible for systemic therapy if they either could not use topical medicine or topical medicines didn’t work well enough for them in the past.
  • Everyone in the study had to have atopic dermatitis that was considered moderate to severe based on rating scales that measured how much of their body surface was affected (10% or more) and the severity of itchiness and other symptoms.

Across all three studies, the average participant ages were 30-37 years, and more than half were male. About 67% of the people who participated in the studies were White, 21% were Asian, and 9% were Black. Many of the people in the studies had other conditions that are common in people with eczema, including asthma, hay fever, food allergies, and allergic conjunctivitis (pink eye due to allergies).

In ECZTRA 1 and 2, people used Adbry or a placebo injection for 16 weeks. No one knew if the injection they were using was the medicine or placebo. Some people  continued to use Adbry or a placebo for 36 more weeks to evaluate long-term safety. 

ECZTRA 3 was done to see if Adbry plus topical corticosteroids was more effective than topical corticosteroids alone. In this study, people used Adbry or a placebo every 2 weeks for 16 weeks. No one knew if the injection they were using was the medicine or placebo. Then those who responded well to Adbry either continued the same treatment or switched to a less frequent dosage (once every 4 weeks) for another 16 weeks. Throughout the study, people also applied mometasone cream, a topical corticosteroid, to affected skin areas and, if needed, other topical medicines.

To measure the effectiveness of Adbry in these studies, researchers used scoring systems to assess the amount of skin affected and the severity of symptoms. Effectiveness was determined based on the percentage of people who achieved a score of 0, meaning clear skin, or 1, meaning almost clear skin, by week 16. Across all of the studies, the results showed that Adbry was more effective than a placebo for making skin clear or almost clear in people with moderate to severe atopic dermatitis. 

The scores on eczema symptom ratings scales also decreased in these studies. This shows that Adbry worked better than a placebo (with or without certain topical medicines) to treat itchiness and other symptoms of atopic dermatitis, according to what people reported throughout the studies.

Some of the main results of these studies are shown in the tables below. Your results may be different from what was seen in studies.

 

Percentage of adults with moderate to severe atopic dermatitis with a score of 0 (“clear”) or 1 (“almost clear”) at week 16

 

Adbry (tralokinumab) 

Placebo

ECZTRA 1 Study

16%

7%

ECZTRA 2 Study

21%

9%

 

Percentage of adults with moderate to severe atopic dermatitis with a score of 0 (“clear”) or 1 (“almost clear”) at week 16

 

Adbry (tralokinumab) plus topical corticosteroids

Placebo plus topical corticosteroids

ECZTRA 3 Study

38%

27%

One study called ECZTRA 6 was done to see if Adbry could be beneficial for children with eczema. The results showed that Adbry was a safe and effective treatment for children ages 12 years and older with moderate to severe atopic dermatitis (eczema). 

The study included children ages 12 to 17 with moderate to severe atopic dermatitis. Everyone in the study had at least 10% of their skin affected by the condition and their symptoms were not controlled well enough by topical medicines. In this study, the average participant age was 16 years with an average weight of 61.5 kilograms (about 135 pounds). The study included children of different races, similar to the diversity of the adult studies of Adbry. Most of the kids (84%) had at least one other allergy-related condition, such as asthma, hay fever, or food allergies.

In ECZTRA 6, children used Adbry or a placebo injection every other week for 16 weeks. No one knew if the injection they were using was the medicine or placebo. Those who responded well continued to use Adbry or a placebo for another 36 weeks. 

Some of the main results of this study are shown in the table below. Your child’s results may be different from what was seen in studies.

Percentage of children ages 12-17 with moderate to severe atopic dermatitis with a score of 0 (“clear”) or 1 (“almost clear”) at week 16

 

Adbry (tralokinumab) 

Placebo

ECZTRA 6 Study

21%

4%

In studies ECZTRA 1 and 2, some people using Adbry reported meaningful improvements in itchiness, sleep, and quality of life within 1 to 2 weeks after starting Adbry. In ECZTRA 3, some people using Adbry also saw early improvements as soon as 2 to 3 weeks. These improvements included less intense itching and better quality of life, along with reduced use of topical corticosteroids to manage eczema symptoms. 

Keep in mind that not everyone in studies saw improvements or this quickly. Talk to your health care provider if you feel that Adbry is not working well for you. They can also give you advice on other ways to manage your symptoms.

Adbry may be used with or without topical medicines. Topicals are medicines that you apply to the affected areas of your skin. For example, your health care provider may prescribe a topical corticosteroid medicine, such as mometasone cream. They may also prescribe other topical medicines. Follow your health care provider’s instructions for using any other medicines while using Adbry.

You should also continue to follow a good skin care routine as recommended by your health care provider. Managing atopic dermatitis usually requires a multistep plan to control symptoms, such as regular moisturizing, avoiding triggers, and using medicines as prescribed. 

Adbry comes as a liquid solution that is given as an injection under the skin (subcutaneous). It is available in two dosage forms: a prefilled syringe and an auto-injector. 

The prefilled syringe contains 150 milligrams per milliliter of solution and is approved for use in adults and children with moderate to severe atopic dermatitis. Parents or caregivers should give Adbry injections to children or supervise their children when using Adbry.

The autoinjector contains 300 milligrams per 2 milliliters of solution and is approved for use in adults with moderate to severe atopic dermatitis. This form is not approved for children.

To compare these forms, it helps to know the typical dosage for Adbry. After the first dose, the usual dosage of Adbry for adults is 300 milligrams given every other week. After 16 weeks, some people may be able to switch to a less frequent dosage of 300 milligrams given once every 4 weeks.

The main difference between the two forms is the number of injections you need for each dose.  To inject a dose of 300 milligrams using the prefilled syringes, you would need to give two injections of 150 milligrams each. But to inject a dose of 300 milligrams using the auto-injector, you would only need to give one injection of 300 milligrams.

If you are using Adbry prefilled syringes, you may want to ask your health care provider about switching to Adbry auto-injector. Some people may prefer the auto-injector because it allows you to inject yourself fewer times per dose. It also has a hidden needle, which may be helpful for people who feel uncomfortable seeing needles. Talk to your health care provider for more information.

Adbry requires a prescription from a health care provider. This most often will be a dermatologist (skin specialist) or allergist (allergy specialist) but could also be your primary care doctor or another health care provider.

Adbry is a specialty medicine. Your local pharmacy does not carry it. Instead, your health care provider will send your prescription to a specialty pharmacy. They can plan with you to ship the medicine to your home. 

A cost assistance program is available from the drugmaker that may allow you to pay $0 for your Adbry prescription. Your eligibility may depend on what type of insurance you have or if you are uninsured. 

For more information about Adbry costs and copay savings, visit www.adbry.com/savings-and-support-programs/savings-programs. You can also call 844-692-3279 to connect with a representative for financial support information and other resources.