LEO Pharma presents new Adtralza® safety data in moderate-to-severe atopic dermatitis at the 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 Adtralza® (tralokinumab) 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

BALLERUP, Denmark, September 8, 2022 – LEO Pharma A/S, a global leader in medical dermatology, today announced new safety data for Adtralza® (tralokinumab) 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 evaluated the long-term safety of Adtralza, 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 Adtralza 300 mg every two weeks (Q2W) with optional topical corticosteroids (TCS) demonstrated a 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 Adtralza for adult patients with moderate-to-severe atopic dermatitis, which build on the long-term safety data presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting,” said Jörg Möller, Executive Vice President, Global Research and Development, LEO Pharma A/S. “We’re committed to supporting patients and clinicians in their quest to find long-term treatment options that help reduce the signs and symptoms of atopic dermatitis, and hope these latest results can help support treatment decisions with Adtralza.”

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 Adtralza 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 Adtralza or placebo in the parent trials.^1,2

The safety profile in this analysis of ECZTEND was consistent up to 3.5 years of Adtralza 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

To access the full presentation, please visit: https://www.leopharmaposters.net/congresses/eadv-2022/presentations/ecztend-42-month-safety

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 Adtralza® (tralokinumab) in patients with atopic dermatitis who participated in the previous Adtralza monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy Adtralza 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 Adtralza plus TCS trial in Japanese subjects (ECZTRA 8), and the Adtralza 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 Adtralza or placebo.^1,3

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.⁴ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁵ Type 2 cytokines, including IL-13, play an important role in atopic dermatitis pathophysiology.⁶

About Adtralza® (tralokinumab)

Adtralza^® (tralokinumab) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine⁷, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.^6,8 Adtralza 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

Adtralza is approved for the treatment of adults with moderate-to-severe AD in the European Union, Great Britain, Canada, the United Arab Emirates, and Switzerland.⁸ It also is approved in the United States under the tradename Adbry^TM (tralokinumab-ldrm). 

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, 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. 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.
4. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
5. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.
6. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
7. 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.

Adtralza^® (tralokinumab) EU Product Information. LEO Pharma; June 2021.