Lebrikizumab delivered long-term disease control for up to four years in patients with moderate-to-severe atopic dermatitis
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In the ADlong Phase 3b study*, 94% of patients achieved meaningful skin improvement (
EASI -75) with up to four years of lebrikizumab treatment, reinforcing the sustained response achieved over time in patients with moderate-to-severe atopic dermatitis1. -
75% of patients achieved near-complete skin clearance (
EASI -90) and 78% experienced meaningful itch relief (Pruritus NRS ≤4), one of the most bothersome symptoms for patients. - At AAD, Almirall and its partners also presented more than 15 posters across atopic dermatitis, psoriasis, actinic keratosis and acne, strengthening its commitment to improving patient outcomes and aligned with its leadership in medical dermatology.
“At Almirall, we are committed to advancing skin science with meaningful therapies that improve patients’ lives. These interim data from the ADlong study further support the long-term value of lebrikizumab in treating patients with moderate-to-severe atopic dermatitis, highlighting its potential to fundamentally improve disease control and positively transform patients’ quality of life
,
” said
“Long-term efficacy is essential in moderate-to-severe atopic dermatitis, a disease characterized by chronic inflammation and unpredictable flares. When a treatment can offer patients sustained control of both skin symptoms and itch over several years, it has the potential to transform daily life and redefine what we consider achievable in AD management,” said
In the ADlong study, the majority of patients achieved near-complete skin clearance and clinically meaningful itch relief with up to four years of continuous lebrikizumab treatment. Most patients (77%) were on lebrikizumab monotherapy, and the majority of patients (80%) achieved these results without topical corticosteroids. In addition, 80% achieved these outcomes with lebrikizumab monthly maintenance dosing during the study.
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Efficacy results at week 48 of ADlong, up to four years of continuous treatment |
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|
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94% |
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75% |
|
IGA 0,1‡ |
68% |
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Pruritus NRS ≤4§ |
78% |
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*Data are reported as observed
**
† ‡ IGA 0,1=Investigator's Global Assessment 0 or 1 ("clear" or "almost clear") § Pruritus NRS=Numeric Rating Scale rating itch from 0-10 with 10 being worst imaginable itch within the past 24 hours |
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The safety of lebrikizumab in this first year of the ADlong study was consistent with the established safety profile in patients with moderate-to-severe atopic dermatitis, and no new safety signals were observed. The majority of adverse events were mild or moderate and did not lead to discontinuation. Reported treatment-related adverse events in the study included nasopharyngitis, URTI and conjunctivitis.
The ADlong study is ongoing and will continue for an additional year of treatment. These results reinforce the sustained response achieved with lebrikizumab over time in patients with moderate-to-severe atopic dermatitis3, building on recently published findings showing that continued treatment for two years enabled a substantial proportion of responder population (41%) to achieve complete skin clearance and itch relief4.
At AAD, Almirall and its partners shared new data and more than 15 posters across atopic dermatitis, psoriasis, actinic keratosis and acne, reinforcing its commitment to improving patient outcomes through advancing science and a diverse portfolio that uses novel modalities to address debilitating conditions such as hidradenitis suppurativa, alopecia areata, and atopic dermatitis.
About ADlong
ADlong (NCT05916365) open-label extension study is evaluating the long-term safety and efficacy of lebrikizumab 250 mg dosed every four weeks (Q4W) in patients with moderate-to-severe atopic dermatitis for a total of 108 weeks. Adult and adolescent patients (ages 12–17, weighing ≥40 kg) from
About Lebrikizumab
Lebrikizumab (LEB) is a monoclonal antibody that selectively targets the cytokine IL-13 with high affinity, blocking its downstream signaling7,8,9,10,11, while avoiding broader immunosuppression12,13 and preserving IL-13 physiological clearance14. Lebrikizumab is approved in
Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in
About Almirall
Almirall is a global biopharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients’ needs.
Almirall, founded in 1944 and headquartered in
Legal warning
This document includes only summary information and is not intended to be exhaustive. The facts, figures and opinions contained in this document, in addition to the historical ones, are "forward-looking statements". These statements are based on the information currently available and the best estimates and assumptions that the company considers reasonable. These statements involve risks and uncertainties beyond the control of the company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The company expressly waives any obligation to revise or update any forward-looking statements, goals or estimates contained in this document to reflect any changes in the assumptions, events or circumstances on which such forward-looking statements are based, unless required by the applicable law.
*These results are interim findings from the first year of the ADlong Phase 3b study and will be publicly disclosed at the
1 Thaçi, et al. Late breaking news EADV 2024, D1T01.2
2
Weidinger S, et al. Efficacy and Safety of Lebrikizumab is Maintained up to 4 Years in Patients With Moderate-to-Severe Atopic Dermatitis: first year of ADlong Long-Term Extension Trial.
3 Thaçi, et al. Late breaking news EADV 2024, D1T01.2
4 Simpson E, Biedermann T, Kircik L, et al. Raising the bar of efficacy in Atopic Dermatitis: deep response in week 16 responders treated with lebrikizumab over 2 years. J Dermatolog Treat. 2026;37(1):2631233. doi:10.1080/09546634.2026.2631233
5
6
Weidinger S, et al. Efficacy and Safety of Lebrikizumab is Maintained up to 4 Years in Patients With Moderate-to-Severe Atopic Dermatitis: first year of ADlong Long-Term Extension Trial.
7 Moyle M, Cevikbas F, Harden JL, Guttman‑Yassky E. Understanding the immune landscape in atopic dermatitis: the era of biologics and emerging therapeutic approaches. Exp Dermatol. 2019;28(7):756‑768.
8 Okragly AJ, Ryuzoji A, Wulur I, Daniels M, Van Horn RD, Patel CN, et al. Binding, neutralization and internalization of the interleukin‑13 antibody, lebrikizumab. Dermatol Ther (Heidelb). 2023;13(7):1535‑1547.
9 Ultsch M, Bevers J, Nakamura G, et al. Structural basis of signaling blockade by anti‑IL‑13 antibody lebrikizumab. J Mol Biol. 2013;425(8):1330‑1339.
10 Tsuji G, Yamamura K, Kawamura K, Kido‑Nakahara M, Ito T, Nakahara T. Novel therapeutic targets for the treatment of atopic dermatitis. Biomedicines. 2023;11:1303.
11 Furue M, Ulzii D, Nakahara T, Tsuji G, Furue K, Hashimoto‑Hachiya A, et al. Implications of IL‑13Rα2 in atopic skin inflammation. Allergol Int. 2020;69:412‑416.
12 Moyle M, Cevikbas F, Harden JL, Guttman‑Yassky E. Understanding the immune landscape in atopic dermatitis: the era of biologics and emerging therapeutic approaches. Exp Dermatol. 2019;28(7):756‑768.
13 Gonçalves F, Freitas E, Torres T. Selective IL‑13 inhibitors for the treatment of atopic dermatitis. Drugs Context. 2021;10:2021‑1‑7. doi:10.7573/dic.2021‑1‑7.
14 Moyle M, Cevikbas F, Harden JL, Guttman‑Yassky E. Understanding the immune landscape in atopic dermatitis: the era of biologics and emerging therapeutic approaches. Exp Dermatol. 2019;28(7):756‑768.
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