FAQ – Adbry (Tralokinumab-ldrm)

What is Adbry?

Adbry (tralokinumab-ldrm) is a biologic drug approved by the FDA for people ages 12 and older with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies used on the skin (topical therapies) or when those therapies are not advisable.

Moderate to severe atopic dermatitis is generally determined by skin involvement (how much of your body surface is affected) and severity of symptoms such as itch and rash that cannot be controlled by topical medications alone. However, atopic dermatitis can be considered moderate or severe if the disease has a significant negative impact on your quality of life, even if the body surface affected is more limited. It’s important to talk to your doctor about how atopic dermatitis affects not just your skin but also other aspects of your life.

Together, you and your healthcare provider can determine if Adbry is an appropriate treatment option.

What type of medicine is Adbry?

Adbry is a biologic, a type of medicine made from living organisms or components from living organisms (like proteins).

Biologics are designed to target specific parts of the immune system that contribute to chronic inflammatory diseases such as atopic dermatitis. Biologics take an “inside out” approach to treating inflammatory conditions.

How does Adbry work?

Adbry works by blocking a type of protein called interleukin-13, or IL-13, from binding to its cell surface receptors (IL-13R alpha 1 and IL-13R alpha 2). IL-13 can be produced by many cells of the immune system and has been found to contribute to the inflammatory processes and decreased barrier functions in atopic dermatitis.

How do you take Adbry?

Adbry is taken by subcutaneous (s.c.) injection (an injection under the skin). Adbry is not available as a pill or a cream.

Like other biologics for AD, Adbry is an antibody with a unique protein structure, and must be given by injection. If given in a pill, our digestive system would break down the structure needed for Adbry to bind to its target, making the drug ineffective.

The recommended dosage of Adbry for adults is an initial 600 mg dose (given as four 150mg injections) followed by 300 mg (given as two 150 mg injections) once every other week.

A dosage of 300 mg once every 4 weeks may be considered for patients weighing less than 100 kg (about 220 lbs) who achieve clear or almost clear skin after 16 weeks of treatment.

For children age 12-17, the initial loading dose is 300 mg, followed by a 150 mg dose every 2 weeks.

How effective is Adbry for atopic dermatitis?

In the ECZTRA 1 and 2 monotherapy clinical trials for adults on Adbry (i.e. Adbry used as a single therapy taken every other week), after 16 weeks on Adbry¹:

Primary Clinical Trial Endpoints:
- Investigator Global Assessment (IGA)
  - A tool used to provide a clinical trial investigator rating of overall disease severity at a particular time point.
  - 15.8 and 22.2% of patients had an IGA score of clear to almost clear (IGA 0 or 1) versus 7.1 and 10.9% on placebo.
- Eczema Area and Severity Index (EASI)-75
  - An investigator tool used to measure the extent (area) and severity of atopic dermatitis. EASI-75 is a 75% improvement in this score from the start of the trial.
  - 25.0 and 33.2% of patients achieved an EASI-75 versus 12.7% and 11.4% on placebo.
Reductions in daily worst itch rating and improved sleep and quality of life were also observed with Adbry vs placebo.
- Patients reported these effects of Adbry versus placebo after 1-2 weeks.

The majority of patients who saw benefit from Adbry at 16 weeks maintained their response at 52 weeks with continued Adbry dosing.
Comparable findings for adolescent patients age 12-17 were observed in the ECZTRA 6 clinical trial.²

LEO Pharma, the company that makes Adbry, has published two plain language summaries of the findings from the Phase III trials that provide additional information:

ECZTRA 1 and 2 clinical trials

ECZTRA 3 clinical trial

What are the most common side effects of Adbry?

In clinical trials, the most common side effects reported were upper respiratory infections, conjunctivitis (pink eye), injection-site reactions, and eosinophilia (a higher than normal level of eosinophils (a type of white blood cell) in the blood). The majority of side effects were mild to moderate in severity, with many resolving by the end of the initial 16-week treatment period.^1,³

Are there other biologics FDA-approved for atopic dermatitis?

Yes. Both Adbry and Dupixent (dupilumab) are biologics FDA-approved for moderate to severe atopic dermatitis. Adbry has a different antibody target than Dupixent. Learn more about Dupixent here. Clinical trials for other biologics for AD are currently underway.

Head-to-head comparative clinical trials of Adbry and Dupixent are not yet available.

How long do I have to take Adbry?

Atopic dermatitis is a chronic skin disease that can affect everyone differently. The length of therapy with Adbry should be discussed with your healthcare provider.

Can children use Adbry?

Adbry was approved by the FDA for adolescents ages 12 and older in December 2023. Adbry is not FDA-approved for younger children, although clinical trials are underway for children age 2 to <12 years of age.⁴

Can I use Adbry with other prescription atopic dermatitis therapies?

Talk to your health care provider about using Adbry with other prescription and over the counter therapies for atopic dermatitis. Adbry can be used in combination with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI).^2,3,⁵ Be sure your doctor knows all medications you are using for your atopic dermatitis as well as other medical conditions.

How much does Adbry cost?

The cost for Adbry depends on your health insurance coverage for prescriptions. LEO Pharma, the company that makes Adbry, has programs that may help with your copay costs if needed. You can learn more at www.adbry.com or by call the Adbry Advocate Program at 1-844-MYADBRY (1-844-692-3279).

How do I know if Adbry is right for me?

It’s important to talk to your doctor about how atopic dermatitis affects your skin and other aspects of your life. Together, you and your healthcare provider can determine if tralokinumab is an appropriate treatment option.

How can I get Adbry?

Adbry is available by prescription only. Talk to your health care provider and visit www.adbry.com to learn more.

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³https://clinicaltrials.gov/ct2/show/study/NCT03526861?term=tralokinumab&cond=atopic+dermatitis&draw=2&rank=6

⁴Gutermuth J, Pink AE, Worm M, Soldbro L, Bjerregård Øland C, Weidinger S.Tralokinumab plus topical corticosteroids in adults with severe atopic dermatitis and inadequate response to or intolerance of ciclosporin A: a placebo-controlled, randomized, phase III clinical trial (ECZTRA 7). Br J Dermatol. 2021 Oct 26. doi: 10.1111/bjd.20832. Online ahead of print.

Wollenberg A, Blauvelt A, Guttman-Yassky E et al. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021 Mar;184(3):437-449. ↩︎
AS, Flohr C, Cork M et al. Efficacy and safety of tralokinumab with moderate to severe atopic dermatitis: The phase 3 ECZTRA 6 randomized clinical trial. JAMA Dermatol. 2023;159(6):596-605. ↩︎
Silverberg JI, Toth D, Bieber T et al. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021 Mar;184(3):450-463. ↩︎
https://clinicaltrials.gov/study/NCT05388760 ↩︎
Gutermuth J, Pink AE, Worm M, Soldbro L, Bjerregård Øland C, Weidinger S.Tralokinumab plus topical corticosteroids in adults with severe atopic dermatitis and inadequate response to or intolerance of ciclosporin A: a placebo-controlled, randomized, phase III clinical trial (ECZTRA 7). Br J Dermatol. 2021 Oct 26. doi: 10.1111/bjd.20832. Online ahead of print. ↩︎