Lebrikizumab provides up to four years of sustained disease control in moderate-to-severe atopic dermatitis
Lebrikizumab Almirall, a global biopharmaceutical company dedicated to advancing medical dermatology, has announced encouraging long-term interim results from its ongoing Phase 3b ADlong clinical trial evaluating lebrikizumab in patients with moderate-to-severe atopic dermatitis (AD). The findings highlight the therapy’s ability to deliver sustained disease control, including significant improvements in skin clearance and itch relief, for up to four years of continuous treatment.
Atopic dermatitis is a chronic inflammatory skin condition characterized by recurrent flares, intense itching, and a substantial impact on quality of life. Achieving durable disease control remains a major goal in its management, particularly for patients with moderate-to-severe disease who often require long-term systemic therapy. The ADlong study was designed to assess the long-term efficacy and safety of lebrikizumab, a targeted monoclonal antibody therapy, in both adult and adolescent populations.
According to the interim data, a remarkable 94% of patients achieved EASI-75, indicating at least a 75% improvement in the Eczema Area and Severity Index compared to baseline. This level of response underscores the therapy’s strong and consistent effectiveness over extended periods. Additionally, 75% of patients reached EASI-90, reflecting near-complete skin clearance, while 68% achieved an Investigator’s Global Assessment (IGA) score of 0 or 1, corresponding to “clear” or “almost clear” skin.
Equally important, the treatment demonstrated significant benefits in reducing itch, one of the most distressing symptoms associated with atopic dermatitis. The data show that 78% of patients reported meaningful itch relief, defined as a Pruritus Numeric Rating Scale (NRS) score of 4 or lower. This improvement is particularly meaningful, as itch is often the symptom that most severely disrupts sleep, daily activities, and overall well-being.
The study results presented reflect outcomes at week 48, with patients continuing treatment for up to four years. Notably, the majority of participants achieved these outcomes while on lebrikizumab monotherapy, with 77% not requiring additional systemic treatments. Furthermore, approximately 80% of patients reached these results without the use of topical corticosteroids, emphasizing the therapy’s potential to reduce reliance on adjunctive treatments.
Another key finding is that 80% of patients maintained their clinical improvements with a convenient monthly maintenance dosing regimen. This aspect of treatment is particularly relevant for long-term adherence and patient satisfaction, as less frequent dosing can ease the burden of chronic disease management.
Safety outcomes from the study further reinforce the favorable profile of lebrikizumab. During the first year of the ADlong trial, no new safety signals were identified, and the treatment’s safety remained consistent with previously established data. Most adverse events were mild to moderate in severity and did not lead to treatment discontinuation. The most commonly reported treatment-related adverse events included nasopharyngitis, upper respiratory tract infections, and conjunctivitis.
These findings were presented at the American Academy of Dermatology (AAD) Annual Meeting, a major global platform for dermatology research and innovation. The presentation of these data highlights the growing body of evidence supporting lebrikizumab as a long-term treatment option capable of delivering sustained clinical benefits in patients with moderate-to-severe atopic dermatitis.
Karl Ziegelbauer, Chief Scientific Officer at Almirall, emphasized the company’s commitment to advancing dermatological science and improving patient outcomes. He noted that the ADlong study results further validate the long-term value of lebrikizumab, demonstrating its potential to significantly improve disease control and positively impact patients’ quality of life over time.
Experts in the field have also underscored the importance of these findings. Professor Weidinger from the University Medical Center Schleswig-Holstein highlighted that long-term efficacy is critical in a chronic condition like atopic dermatitis, which is marked by persistent inflammation and unpredictable disease flares. He pointed out that treatments capable of providing sustained control of both visible symptoms and itch over multiple years have the potential to redefine treatment expectations and transform patients’ daily lives.
The ADlong study remains ongoing and will continue for an additional year, providing further insights into the durability of response and long-term safety of lebrikizumab. These interim findings build upon previously published data demonstrating that continued treatment over two years enabled a significant proportion of patients—approximately 41%—to achieve complete skin clearance and itch relief. Together, these results suggest that prolonged therapy may lead to even greater levels of disease control for certain patients.
In addition to the ADlong study results, Almirall and its partners showcased a broad range of research at the AAD Annual Meeting, presenting more than 15 posters across multiple dermatological conditions, including atopic dermatitis, psoriasis, actinic keratosis, and acne. This extensive scientific presence highlights the company’s ongoing commitment to advancing dermatological care through innovation and research.
Almirall’s broader pipeline reflects a strategic focus on addressing unmet needs in dermatology through novel therapeutic approaches. The company is actively exploring treatments for several challenging and often debilitating conditions, including hidradenitis suppurativa, alopecia areata, and atopic dermatitis. By leveraging diverse modalities and cutting-edge science, Almirall aims to deliver more effective and personalized treatment options for patients worldwide.
Overall, the interim results from the ADlong Phase 3b study reinforce lebrikizumab’s potential as a long-term therapeutic option for moderate-to-severe atopic dermatitis. The combination of high response rates, sustained efficacy, meaningful itch reduction, and a consistent safety profile positions the therapy as a promising advancement in the management of this chronic condition.
As research continues and additional data emerge, lebrikizumab may play an increasingly important role in redefining treatment goals for atopic dermatitis, shifting the focus toward sustained disease control, improved quality of life, and long-term remission.
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 Germany and Poland who completed the 100-week ADjoin extension study, including responders from the ADvocate 1 and 2 trials (52 weeks), ADore trial (52 weeks) and the ADhere (16 weeks) trial, were eligible to enroll in ADlong. Patients (N=174) in this analysis receive open-label lebrikizumab 250 mg Q4W, regardless of their previous treatment in ADjoin (Q2W or Q4W dose). The approved maintenance dose of lebrikizumab is 250 mg once monthly, after taking lebrikizumab every two weeks for the four-month initial dosing phase (or later once achieving adequate clinical response)5. Intermittent use of topical rescue medications and short-term systemic treatments was allowed6. If response was below EASI50, Q2W could be used and thereafter Q4W could be resumed.
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 Europe, under the brand name Ebglyss®, for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy15.
Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe, while Eli Lilly and Company retains rights for development and commercialization in the U.S. and the rest of the world outside Europe.
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 Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2025: €1114.5 MM, over 2100 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries.
