LEO Pharma Presents New Interim Long-Term Efficacy Data for Adbry™ (tralokinumab-ldrm) in Moderate-to-Severe Atopic Dermatitis at the 2022 RAD Conference

• Interim post-hoc efficacy analysis from ECZTEND, an open-label, 5-year extension trial, showed long-term improvements in extent and severity of atopic dermatitis and itch in a subgroup of adult patients treated with Adbry for 3 years.¹

• The safety results from the interim analysis were consistent with the known safety profile observed in the previous studies with Adbry.¹

MADISON, N.J.--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced 3-year data that help provide insight into the long-term 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 4th Annual Revolutionizing Atopic Dermatitis (RAD) Conference.¹

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, one of the drivers of AD signs and symptoms.^2,3,4

An interim post-hoc analysis of the ECZTEND long-term, open-label extension trial (NCT03587805) showed treatment with Adbry 300 mg every other week (Q2W) plus optional topical corticosteroids (TCS) for 3 years sustained the improvements in extent and severity of AD that were observed in the parent trials in adult patients with moderate-to-severe AD. Improvements in itch severity, sleep interference, and quality of life also were maintained for up to 3 years in ECZTEND.¹

“This latest readout from ECZTEND helps increase our understanding of the long-term efficacy of Adbry and helps provide healthcare professionals with valuable information as they consider treatment options for patients,” said Richard Langley, MD, FRCPC, FACP, Professor of Medicine and Director of Research in the Division of Clinical Dermatology and Cutaneous Science at Dalhousie University in Halifax, Nova Scotia, Canada. “It is encouraging to have more data available to inform those seeking a biologic option to help manage moderate-to-severe AD.”

The 3-year interim efficacy analysis evaluated a subgroup of 347 patients, among the 1,442 patients enrolled in ECZTEND, who had completed 3 years of treatment with Adbry at data cut-off including 1 year of treatment in the parent trials.¹ Patients were eligible for ECZTEND regardless of their treatment response or whether they were treated with Adbry or placebo in the parent trials.

In patients who completed 3 years of treatment with Adbry, the median Eczema Area and Severity Index (EASI) score improved by 93% (2.0 at 3 years and 26.7 at parent-trial baseline).¹

Additional improvements in extent and severity of AD were sustained at 3 years of treatment with Adbry, including: ¹

• 83% of patients achieved at least 75% improvement in EASI score (EASI-75).¹
• 59% of patients achieved at least 90% improvement in EASI score (EASI-90).¹
• 48% of patients achieved an Investigator Global Assessment score of 0/1 (IGA 0/1), indicating clear or almost clear skin.¹

Furthermore, 83% of patients treated with Adbry for 3 years achieved mild disease, defined as EASI ≤7.¹

Improvements in itch, sleep, and quality of life were maintained at 3 years in ECZTEND:¹

• Median Worst Weekly Pruritus Numeric Rating Scale (NRS) and Eczema-related Weekly Sleep NRS scores remained <4.0 (Pruritus: 3.0 at 3 years, n=273; Sleep: 1.0 at 3 years, n=273)
• Median Dermatology Life Quality Index scores reflected a small (defined as 2 to 5 on a scale of 0 to 30) effect of AD on patient life (2.0 at 3 years, n=270)

Data reported are as observed (n=274). Comparable treatment responses were observed by modified non-responder imputation and last observation carried forward analyses, as reported at the RAD Conference.

The safety profile in this interim analysis was consistent with the safety profile observed in previous controlled studies with Adbry. Among patients who had completed 3 years of Adbry treatment (n=347), 85.0% reported at least one adverse event (AE), 8.9% reported serious AEs, and 2.6% reported AEs leading to withdrawal from the trial.¹ In an interim safety analysis up to 3.5 years presented at AAD 2022 (n=1,442), 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.⁵

“LEO Pharma is pleased that the ECZTEND trial findings continue to provide support for the long-term efficacy profile of Adbry,” said Adriana Guana, M.D., Vice President, U.S. Medical Affairs, LEO Pharma Inc. “We anticipate the availability of these results will have a meaningful impact on the treatment landscape for the AD community and look forward to future readouts.”

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.^1,6

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.⁷ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁸ Type 2 cytokines, including IL-13, play an important role in 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 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.

References

1. Langley R, Reich K, Simpson E, et al. Long-term improvements in disease severity, itch, and quality of life after 3 years of tralokinumab treatment in adults with moderate-to-severe atopic dermatitis. Presented at 4^th Annual Revolutionizing Atopic Dermatitis (RAD) Conference, Baltimore, Md., April 9-11, 2022. Poster Presentation #241.
2. Adbry™ (tralokinumab-ldrm) Prescribing Information. LEO Pharma; January 2022.
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. 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.
6. 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.
7. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
8. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.

MAT-55820 April 2022