LEO Pharma presents new AdbryTM (tralokinumab-ldrm) safety data in moderate-to-severe atopic dermatitis at 31st EADV Congress

• An interim safety analysis from ECZTEND, an open-label, 5-year extension trial, demonstrated consistent safety from the parent trials for up to 3.5 years of Adbry™ (tralokinumab-ldrm) treatment in adult patients with moderate-to-severe atopic dermatitis.¹
• Exposure-adjusted incidence rates of adverse events of special interest, including conjunctivitis, eczema herpeticum, and skin infections requiring systemic treatment, were generally lower than rates reported during the placebo-controlled period up to Week 16 and declined over time.¹

MADISON, N.J.--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced new safety data for Adbry^TM (tralokinumab-ldrm) for adult patients with moderate-to-severe atopic dermatitis (AD). Interim results were shared as an oral presentation at the 31st European Academy of Dermatology and Venereology (EADV) Congress.¹

An interim analysis of the ongoing open-label ECZTEND trial (NCT03587805) evaluated the long-term safety of Adbry, including adverse events of special interest (AESI), in adult patients with moderate-to-severe AD.¹ The AESI were predefined based on areas of safety interest for monoclonal antibodies in AD, including conjunctivitis, skin infections requiring systemic treatment, eczema herpeticum, and malignancies diagnosed after dosing.¹ Long-term treatment with Adbry 300 mg every two weeks (Q2W) with optional topical corticosteroids (TCS) demonstrated consistent safety from the parent trials for up to 3.5 years.¹ Exposure-adjusted incidence rates of AESI were generally lower than the rates reported during the placebo-controlled period up to Week 16 and declined over time.¹

“We're pleased to share these latest findings into targeted IL-13 inhibition with Adbry for adult patients with moderate-to-severe atopic dermatitis," said Adriana Guana, M.D., Vice President, U.S. Medical Affairs, LEO Pharma Inc. “These findings build on the long-term safety data presented at the American Academy of Dermatology (AAD) 2022 Annual Meeting, which demonstrated Adbry's consistent safety from the parent trials. We recognize safety is paramount to patients and clinicians as they consider treatment options for moderate-to-severe atopic dermatitis, and we hope these results inspire continued confidence in Adbry.”

The interim safety analysis included 1,442 patients from the ECZTRA 1, 2, 3, 4, 5, and 7 parent trials who had received at least 1 dose of Adbry in ECZTEND as of April 30, 2021.¹ Patients were followed for up to 3.5 years (≤1 year in the parent trials and ≤2.5 years in the open-label extension ECZTEND trial) and were eligible for ECZTEND regardless of their treatment response or whether they were treated with Adbry or placebo in the parent trials.²

The safety profile in this analysis of ECZTEND was consistent up to 3.5 years of Adbry treatment (total exposure time: 2,446.2 patient-years of exposure [PYE]):¹

• Overall, there were 198.7 number of events [nE]/100 PYE, the majority of which were mild (132.6 nE/100 PYE); most serious AEs (4.9 nE/100 PYE) were reported as single events without clustering on type.
• The most frequently reported treatment-emergent AEs (≥5.0% of patients) were viral upper respiratory tract infection (18.2 nE/100 PYE, mainly reported as common cold), atopic dermatitis (17.9 nE/100 PYE), upper respiratory tract infection (5.8 nE/100 PYE), headache (4.4 nE/100 PYE), and conjunctivitis (3.8 nE/100 PYE).

Exposure-adjusted incidence rates of AESI were generally lower than the rates reported during the placebo-controlled period up to Week 16 and declined over time.¹ No events of conjunctivitis AEs were severe AEs, and only 4 (0.3%) patients discontinued due to conjunctivitis AEs.¹

Additional efficacy and safety data for Adbry will be presented by LEO Pharma at EADV Congress 2022, including:

• A post hoc subgroup analysis of ECZTEND that evaluated the efficacy and safety of 3 years of Adbry treatment, using clinically relevant outcomes indicating disease control, in adults with moderate-to-severe AD.³
• Detailed safety data up to 52 weeks from the Phase 3 ECZTRA 6 monotherapy trial (NCT03526861) that assessed Adbry in adolescent patients (age 12-17 years) with moderate-to-severe AD.⁴

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 targets and neutralizes the interleukin (IL)-13 cytokine, one of the drivers of AD signs and symptoms.^5,6,7

To access the full presentations, please visit: https://www.leopharmaposters.net/congresses/eadv-2022

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 Adbry^TM (tralokinumab-ldrm) in patients with atopic dermatitis who participated in the previous Adbry monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy Adbry 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 Adbry plus TCS trial in Japanese subjects (ECZTRA 8), and the Adbry 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 Adbry or placebo.^1,8

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.⁹ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.¹⁰ Type 2 cytokines, including IL-13, play an important role in atopic dermatitis pathophysiology.⁷

About Adbry^™ (tralokinumab-ldrm)

Adbry^TM (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).^6,7

INDICATION AND IMPORTANT SAFETY INFORMATION

What is ADBRY?

• ADBRY^TM (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. Reich K, Simpson E, Langley R, et al. Tralokinumab demonstrated a consistent safety profile with up to 42 months of treatment in moderate-to-severe atopic dermatitis: including adverse events of special interest. Presented at 31st European Academy of Dermatology and Venereology (EADV) Congress, Milan, Italy, September 7-10, 2022. Oral Presentation #FC03.
2. 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.
3. Warren R, Reich K, Simpson E, et al. 3 years of tralokinumab treatment provides long-term disease control as demonstrated by clinically meaningful outcomes in moderate-to-severe atopic dermatitis. Presented at 31st European Academy of Dermatology and Venereology (EADV) Congress, Milan, Italy, September 7-10, 2022. Oral Presentation #FC08.
4. Wollenberg A, Cork M, Flohr C, et al. Safety of tralokinumab in paediatric patients aged 12-17 with moderate-to-severe atopic dermatitis: results from the phase 3 ECZTRA 6 trial. Presented at 31st European Academy of Dermatology and Venereology (EADV) Congress, Milan, Italy, September 7-10, 2022. Oral Presentation #FC02.
5. Adbry™ (tralokinumab-ldrm) Prescribing Information. LEO Pharma; July 2022.
6. 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.
7. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
8. Blauvelt A, et al. Long-term 2-Year Safety and Efficacy of Tralokinumab in Adults with Moderate-to-severe Atopic Dermatitis: Interim Analysis of the ECZTEND Open-label Extension Trial. Journal of the American Academy of Dermatology. 2022.
9. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
10. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.

MAT-59151 September 2022