LEO Pharma Announces Publication of Adbry™ (tralokinumab-ldrm) Efficacy Data in Moderate to Severe Atopic Dermatitis in the American Journal of Clinical Dermatology

MADISON, NJ–(BUSINESS WIRE)–LEO Pharma A/S, a global leader in medical dermatology, today announced that American Journal of Clinical Dermatology published the 32-week results of a post-hoc analysis of the ECZTRA 3 Phase 3 clinical trial (NCT03363854) in atopic dermatitis (AD). Analysis showed treatment with Adbry^™ (tralokinumab-ldrm) plus topical corticosteroids (TCS) as needed demonstrated improvements in the extent and severity of AD, sleep interference, and quality of life over 32 weeks in adults with Moderate to severe AD.¹

Adbry, a high-affinity human monoclonal antibody, was approved by the United States Food and Drug Administration (FDA) in December 2021 for the treatment of adults with moderate to severe AD and is the first and only FDA-approved biologic that specifically binds and inhibits the cytokine interleukin (IL)-13one of the drivers of AD signs and symptoms.^2.3

A pre-specified analysis of patients achieving a response at week 16 has been reported elsewhere.⁴ To reflect clinical practice, this post-hoc analysis pooled all patients treated with Adbry every other week (Q2W) during the initial treatment period, regardless of response at week 16 and dosing regimen (Q2W or every four weeks [Q4W]) received beyond week 16.¹Post-hoc analysis revealed that treatment with Adbry plus TCS, as needed, improved the extent and severity of AD, as well as sleep interference and quality of life measures over 32 weeks.¹

Specifically, results at week 32 (n=252) demonstrated that patients treated with Adbry:¹

Improvement in the extent and severity of AD, with 70.2% achieving a 75% or greater improvement in the Eczema Area and Severity Index (EASI-75) score and 50.4% reaching EASI-90.
Achieved a 70.8% improvement in the weekly mean Numerical Rating Scale (NRS) of Eczema-Related Sleep Interference from baseline.
Achieved a 66.8% improvement in Dermatologic Quality of Life Index (DLQI) from baseline.

At week 16 (n=247), 89.9% of patients starting treatment with Adbry achieved clinically meaningful improvements in at least one of three disease measures, including extent and severity of AD (≥50% improvement in EASI score [EASI-50]), pruritus (improvement ≥ 3 points in the weekly average of the NRS of the worst daily pruritus) or quality of life (reduction ≥ 4 points in the DLQI score).¹ Additionally, 75.3% of patients achieved EASI-50 as well as clinically meaningful improvements in pruritus or quality of life.¹

Safety results have been previously reported for ECZTRA 3. The most common adverse events with Adbry (incidence ≥1% and greater than placebo) were upper respiratory tract infections (predominantly reported as a cold), conjunctivitis, allergic reactions injection site and eosinophilia.^1.2

“This latest peer-reviewed publication adds to the body of research to support the efficacy and safety of Adbry,” said Adriana Guana, MD, Vice President, US Medical Affairs, LEO Pharma Inc. “The results provide additional context on the benefits of Adbry, including the impact on metrics that are important to clinicians and patients and, ultimately, can help inform clinical decisions.

To view the published manuscript, please visit https://link.springer.com/article/10.1007/s40257-022-00702-2.

Manuscript authors include: Jonathan I. Silverberg, David N. Adam, Matthew Zirwas, Sunil Kalia, Jan Gutermuth, Andreas Pinter, Andrew E. Pink, Andrea Chiricozzi, Sébastien Barbarot, Thomas Mark, Ann-Marie Tindberg, and Stephan Weidinger.

About the ECZTRA 3 trial

ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a multinational, double-blind, randomized, placebo-controlled, 32-week study that included 380 adult patients, to evaluate the efficacy and safety of tralokinumab -ldrm (300 mg) in combination with TCS in adults with moderate to severe atopic dermatitis who are candidates for systemic therapy.⁴

About atopic dermatitis

Atopic dermatitis is a chronic inflammatory skin disease characterized by intense itching and eczematous lesions.⁵Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, resulting in chronic inflammation.⁶Type 2 cytokines, including IL-13, play an important role in the pathophysiology of atopic dermatitis.^seven

About Adbry^™ (tralokinumab-ldrm)

Adbry^™ (tralokinumab-ldrm) is a high-affinity human monoclonal antibody developed to bind to and inhibit the cytokine interleukin (IL)-13, which plays a role in the immune and inflammatory processes underlying the signs and symptoms of atopic dermatitis . Adbry specifically binds to the cytokine IL-13, thereby inhibiting interaction with the α1 and α2 subunits of IL-13 receptors (IL-13Rα1 and IL-13Rα2).^3.7

INDICATION AND IMPORTANT SAFETY INFORMATION

What is ADBRY?

ADBRY^™ (tralokinumab-ldrm) injection is a prescription medicine used to treat adults with moderate to severe atopic dermatitis (eczema) that is not well controlled by prescription treatments used on the skin (topicals) or cannot use topical treatments. ADBRY can be used with or without topical corticosteroids.
It is not known if ADBRY is safe and effective in children.

Do not use ADBRY if you are allergic to tralokinumab or any of its ingredients.

What should I discuss with my healthcare provider before starting ADBRY?

Tell your healthcare provider about all your medical conditions, including if you:

have eye problems.
have a parasitic infection (helminths).
are scheduled to receive vaccinations. You should not receive a ‘live vaccine’ if you are being treated with ADBRY.
are pregnant or plan to become pregnant. It is not known if ADBRY will harm your unborn baby.
are breastfeeding or planning to breastfeed. It is not known if ADBRY passes into your breast milk and if it can harm your baby.

Tell your health care provider about all medications you take, including prescription and over-the-counter medications, vitamins, and herbal supplements.

How should I use ADBRY?

See the detailed “Instructions for Use” provided with ADBRY for information on how to prepare and inject ADBRY and how to properly store and dispose of (dispose of) used ADBRY pre-filled syringes.
Use ADBRY exactly as prescribed by your healthcare provider.
Your healthcare provider will tell you how much ADBRY to inject and when to inject it.
ADBRY comes as a single dose (150 mg) pre-filled syringe with a needle shield.
ADBRY is given by injection under the skin (subcutaneous injection).
If your healthcare professional decides that you or a caregiver can administer the ADBRY injection, you or your caregiver should be trained in the proper way to prepare and inject ADBRY. Not try injecting ADBRY until your healthcare professional shows you the right way.
If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at the scheduled time.
If you inject more ADBRY than prescribed, call the poison control center at 1-800-222-1222.
Your healthcare provider may prescribe other medicines for you to use with ADBRY. Use other prescribed medications exactly as your healthcare professional has told you.

What are the possible side effects of ADBRY?

ADBRY can cause serious side effects, including:

Allergic (hypersensitivity) reactions, including a serious reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you have any of the following symptoms:
- breathing problems
- itch
- itchy skin
- swelling of the face, mouth and tongue
- fainting, dizziness, lightheadedness (low blood pressure)
- urticaria
Eye problems. Tell your healthcare provider if you have any worsening eye problems, including eye pain or changes in vision.

The most common side effects of ADBRY include:

Inflammation of the eyes and eyelids, including redness, swelling and itching
Injection site reactions
High number of a certain white blood cell (eosinophilia)

These are not all possible side effects of ADBRY. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Please Click here for complete prescribing information, including patient information and instructions for use.

About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority-owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advancing the science of dermatology, and today the company offers a wide range of therapies for all severities of skin disease. sickness. LEO Pharma is headquartered in Denmark and has a global team of 5,800 people, serving millions of patients around the world. In 2021, the company had net revenue of $1,539 million.

References

Silverberg, JI, et al. Tralokinumab plus topical corticosteroids as needed provide gradual and sustained efficacy in adults with moderate to severe atopic dermatitis over 32 weeks: an ECZTRA 3 post hoc analysis. American Journal of Clinical Dermatology. 2022.
Adbry™ (tralokinumab-ldrm) prescribing information. LEO Pharma; January 2022.
Popovic B, et al. Structural characterization reveals the mechanism of the IL-13 neutralizing monoclonal antibody, tralokinumab, as inhibition of IL-13Rα1 and IL-13Rα2 binding. J Mol Biol. 2017; 429:208–19.
Silverberg JI, et al. Tralokinumab plus topical corticosteroids for the treatment of moderate to severe atopic dermatitis: results from the phase III, randomized, multicenter, double-blind, placebo-controlled ECZTRA 3 trial. British Journal of Dermatology. 2021.
Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
Boguniewicz M, et al. Atopic dermatitis: a disease characterized by an alteration of the skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.
Bieber T. Interleukin-13: targeting an underappreciated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.