MADISON, N.J.--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced up to 3.5-year data that further support the long-term safety and efficacy profile of Adbry™ (tralokinumab-ldrm) in adult patients with moderate-to-severe atopic dermatitis (AD). Interim results were shared as a poster presentation at the American Academy of Dermatology (AAD) 2022 Annual Meeting.¹

“It is reassuring to see such consistent results as the ECZTEND trial continues to unfold”

Adbry, a high-affinity human monoclonal antibody, was approved by the U.S. 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 to and inhibits the interleukin (IL)-13 cytokine, a key driver of AD signs and symptoms.^2,3,4

The 3.5-year interim safety analysis in more than 1,400 patients from the ECZTEND long-term, open-label extension trial (NCT03587805) showed that the overall safety profile of Adbry 300 mg every other week (Q2W) plus optional topical corticosteroids (TCS) was consistent with that observed in the parent trials of tralokinumab-ldrm, with no new safety signals emerging. The interim efficacy analysis showed Adbry 300 mg Q2W plus optional TCS demonstrated sustained improvement in extent and severity of atopic dermatitis, itch severity, and quality of life in adult patients treated with Adbry for up to 3 years.¹ Patients who had enrolled in the parent trials and continued into ECZTEND were on treatment for up to 3.5 years, including up to 2.5 years in ECZTEND and up to one year in the parent trials.

“It is reassuring to see such consistent results as the ECZTEND trial continues to unfold,” said Andrew Blauvelt, MD, MBA, President of the Oregon Medical Research Center in Portland, Oregon, and lead investigator of ECZTEND. “The latest interim safety and efficacy findings are similar to earlier reports and continue to reinforce the rationale for treatment specifically targeting IL-13 in adult patients with moderate-to-severe atopic dermatitis.”

The 3.5-year interim safety analysis included 1,442 patients from the parent trials ECZTRA 1 and 2, ECZTRA 3, ECZTRA 4, ECZTRA 5, and ECZTRA 7 who had received at least one dose of Adbry.¹ Patients were eligible for ECZTEND regardless of their treatment response or whether they were treated with Adbry or placebo in the parent trials.¹ From ECZTEND baseline to data cut-off (up to 2.5 years in ECZTEND), 22.9% of patients had withdrawn from the study, and discontinuation rates due to an adverse event (AE) were 2.4%.¹ The most frequently reported AEs (occurring in at least 5% of participants) included viral upper respiratory tract infection (mainly reported as common cold), atopic dermatitis, upper respiratory infection, headache, and conjunctivitis. None of the conjunctivitis events were serious AEs.¹ Overall, the safety profile in ECZTEND was similar to that observed with Adbry in the parent trials.¹

In the cohort of 616 patients who received Adbry for up to 3 years, 85.1% achieved at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75).¹ Half of the patients (50.5%) achieved an Investigator Global Assessment score of 0/1 (IGA 0/1), indicating clear or almost clear skin.¹ Additionally, patients achieved improvements in itch and quality of life as measured by 60.6% of patients achieving a Worst Weekly Pruritus Numerical Rating Scale (NRS) score of ≤3 and 76.4% achieving a Dermatology Life Quality Index (DLQI) score of ≤5.¹ Data reported as observed. The modified non-responder imputation and last observation carried forward analyses were also reported in the poster and results were comparable across the three analyses.

“At LEO Pharma, it is our mission to help people living with debilitating dermatological conditions, and we are gratified to see such encouraging data emerge from the ongoing ECZTEND long-term extension trial,” said Adriana Guana, Vice President, Medical Strategy and Scientific Affairs, LEO Pharma Inc. United States. “The latest analysis shows that the safety and efficacy profile of Adbry, administered at the dose indicated on our label, are sustained long-term and we look forward to additional data readouts from ECZTEND.”

To view the full presentation, please visit leopharmaposters.net/congresses/aad-2022/posters/ecztend-2-year.

About the ECZTEND - Long-Term Extension (LTE) Trial

ECZTEND (Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials) is an ongoing Phase 3, long-term, five-year, open-label, single-arm extension trial to evaluate the safety and efficacy of tralokinumab-ldrm in patients with atopic dermatitis who participated in the previous tralokinumab-ldrm monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy tralokinumab-ldrm plus TCS trial (ECZTRA 3), the Drug-drug interaction (DDI) trial (ECZTRA 4), the vaccine trial (ECZTRA 5), the adolescent trial (ECZTRA 6), the oral cyclosporine A trial (ECZTRA 7), the combination therapy tralokinumab-ldrm plus TCS trial in Japanese subjects (ECZTRA 8), and the tralokinumab-ldrm monotherapy skin barrier function trial (TraSki). Patients were permitted to enter ECZTEND after completion of the parent trial regardless of their treatment response or whether they were treated with tralokinumab-ldrm or placebo.^1,5

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.⁶ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁷ Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.⁴

About Adbry™ (tralokinumab-ldrm)

Adbry™ (tralokinumab-ldrm) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a key role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms. Adbry specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).^3,4

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 with prescription therapies used on the skin (topical), or who cannot use topical therapies. 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 to 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 (helminth) infection.
• are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY.
• are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.

How should I use ADBRY?

• See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled 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) prefilled syringe with needle guard.
• ADBRY is given as an injection under the skin (subcutaneous injection).
• If your healthcare provider decides that you or a caregiver can give the injection of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider.
• If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
• If you inject more ADBRY than prescribed, call Poison Control at 1-800-222-1222.
• Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the possible side effects of ADBRY?

ADBRY can cause serious side effects including:

• Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
  • breathing problems
  • itching
  • skin rash
  • swelling of the face, mouth, and tongue
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • hives
• 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:

• Eye and eyelid inflammation, including redness, swelling, and itching
• Injection site reactions
• High count of a certain white blood cell (eosinophilia)

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

Please click here for full 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 advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 5,800 people, serving millions of patients across the world. In 2021, the company generated net sales of USD 1,539 million.

Dr. Blauvelt is an ECZTEND clinical trial investigator and a paid consultant to LEO Pharma A/S.

References

1. Blauvelt A, Langley R, Simpson E, et al. Long-term safety and efficacy of tralokinumab in more than 1400 moderate-to-severe atopic dermatitis patients treated for up to 42 months: an interim analysis of ECZTEND. Presented at American Academy of Dermatology (AAD) 2022 Annual Meeting, Boston, Mass., March 25-29, 2022.
2. Adbry™ (tralokinumab-ldrm) Prescribing Information. LEO Pharma; December 2021.
3. Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017; 429:208–19.
4. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
5. ClinicalTrials.gov. National Library of Medicine (U.S.). Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials – ECZTEND. https://clinicaltrials.gov/ct2/show/NCT03587805.
6. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
7. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.