In the ADlong Phase 3b study, nearly all EBGLYSS-treated patients achieved meaningful skin improvement (EASI-75) for up to four years
75% of patients achieved a high bar of near-complete skin clearance (EASI-90) and 78% experienced significant itch relief (Pruritus NRS =4), one of the most bothersome symptoms for patients
80% of patients achieved durable results without the need for topical corticosteroids
INDIANAPOLIS, March 27, 2026 /PRNewswire/ -- New long-term data show Eli Lilly and Company's (NYSE: LLY) EBGLYSS (lebrikizumab-lbkz) delivered durable skin clearance?and?relief from persistent?itch for up to four years for patients with moderate-to-severe atopic dermatitis (eczema) in an open-label extension study offering once-monthly maintenance injection. Interim findings from the first year of the ADlong Phase 3b study will be presented at the American Academy of Dermatology (AAD) Annual Meeting, taking place March 27-31 in Denver.1
"These data underscore our unwavering commitment to expanding what people with moderate-to-severe atopic dermatitis can achieve with treatment," said Adrienne Brown, executive vice president and president, Lilly Immunology. "For too long the focus has been around symptom management and many patients struggle to achieve consistent disease control despite cycling through topical treatments. EBGLYSS is helping transform this treatment paradigm-allowing people the opportunity to reimagine life without the frequent interruptions caused by flares or topicals applied 2-3 times per day."
EBGLYSS is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity and slow dissociation rate.2,3,4 The cytokine IL-13 is a primary cytokine in atopic dermatitis, driving the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.5,6
In the ADlong study, the majority of patients achieved a high bar of near-complete skin clearance and significant itch relief with up to four years of continuous EBGLYSS treatment. Most patients (77%) were on EBGLYSS monotherapy, and 80% achieved results without topical corticosteroids. In addition, 80% achieved these outcomes with EBGLYSS monthly maintenance dosing during the study.
Efficacy results at up to four years of continuous treatment* | |
EASI-75** | 94 % |
EASI-90† | 75 % |
IGA 0,1‡ | 68 % |
Pruritus NRS =4§ | 78 % |
* Data are reported as observed
** EASI=Eczema Area and Severity Index; EASI-75=75% reduction in EASI from baseline
† EASI-90=90% reduction in EASI from baseline
‡ 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
The safety of EBGLYSS in the first year of the ADlong study was consistent with the known profile in patients with moderate-to-severe atopic dermatitis, regardless of dose frequency, 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 conjunctivitis (6.9%) and injection-site reactions (0.6%).
The ADlong study is ongoing and will continue for an additional year of treatment. These results reinforce previously reported long-term results for EBGLYSS for patients with moderate-to-severe atopic dermatitis. In addition, a post-hoc analysis presented at Maui Derm Hawaii 2026 on EASI-75 stable responders showed less than one flare per patient per year with EBGLYSS monthly maintenance dosing used as monotherapy.7
"There is still an unmet need for people with moderate-to-severe atopic dermatitis who frequently experience unpredictable flares and are in need of treatment options that go beyond just symptomatic relief and address the underlying inflammation driving skin symptoms and persistent itch," said Emma Guttman-Yassky, M.D., Ph.D., The Waldman Professor and Health System Chair, Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York. "These four-year findings reinforce that EBGLYSS has the potential to deliver durable disease control, helping patients flare less with or without topicals."
Lilly continues to raise the standard of care in dermatology and boldly invest in the next wave of immunology innovation, which includes big bets on next-generation modalities, the targeted expansion of small molecules and advancing novel science that uncovers the potential of incretins. Lilly recently shared topline findings from the TOGETHER-PsA and TOGETHER-PsO trials investigating the concomitant use of ixekizumab and an incretin-based therapy to treat adults with psoriatic disease and obesity or overweight with at least one additional weight-related comorbid condition. Lilly's investigational therapies include DC-853, a novel oral IL-17 inhibitor being studied for psoriasis, and eltrekibart, a novel monoclonal antibody that targets neutrophil-driven inflammation and is being assessed in hidradenitis suppurativa.
Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe. Lilly's partner Almirall has licensed the rights to develop and commercialize EBGLYSS for the treatment of dermatology indications, including atopic dermatitis, in Europe.
About ADlong
ADlong (NCT05916365) open-label extension study is evaluating the long-term safety and efficacy of EBGLYSS 250 mg dosed every four weeks (Q4W) in patients with moderate-to-severe atopic dermatitis for a total of 108 weeks. Adult and adolescent (ages 12-17, weighing =40 kg) patients from select countries in Europe who completed the 100-week ADjoin extension study, including patients who completed the ADore trial (52 weeks), the ADhere trial (16 weeks), and Week 16 responders who completed the ADvocate 1 and 2 trials (52 weeks), were eligible to enroll in ADlong. Patients (N=174) in this analysis receive open-label EBGLYSS 250 mg Q4W, regardless of their previous treatment in ADjoin (Q2W or Q4W dose). The approved maintenance dose of EBGLYSS is 250 mg once monthly, after taking EBGLYSS every two weeks for the four-month initial dosing phase (or later once achieving adequate clinical response).8 Intermittent use of topical rescue medications and short-term systemic treatments was allowed.1 If response was below EASI-50, Q2W could be used and thereafter Q4W could be resumed.
About EBGLYSS
EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate.3,4,8 EBGLYSS binds to the IL-13 cytokine at an area that overlaps with the binding site of the IL-4Ra subunit of the IL-13Ra1/IL-4Ra heterodimer, preventing formation of this receptor complex and inhibiting IL-13 signaling. IL-13 is implicated as a primary cytokine tied to the pathophysiology of eczema, driving the type-2 inflammatory loop in the skin, and EBGLYSS selectively targets IL-13.8
The EBGLYSS Phase 3 program in atopic dermatitis consists of seven key global studies evaluating over 1,600 patients, including two monotherapy studies (ADvocate 1 and 2), a combination study with topical corticosteroids (ADhere), long-term extension (ADjoin), adolescent open-label (ADore) and pediatric (ADorable 1 and 2) studies. EBGLYSS is also being studied in allergic rhinitis and chronic rhinosinusitis with nasal polyps.
EBGLYSS was approved in the U.S., Japan and Canada in 2024 and in the European Union in 2023. EBGLYSS is a first-line biologic treatment with the option of monotherapy that offers once-monthly maintenance dosing for adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis that is not well controlled with topical prescription therapies.8 EBGLYSS 250 mg/2 mL injection is dosed as a single monthly maintenance injection following the initial phase of treatment. The recommended initial starting dose of EBGLYSS is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later when adequate clinical response is achieved; after this, maintenance dosing is a single monthly injection (250 mg every four weeks) which can be used with or without topical corticosteroids.8
Lilly is committed to serving patients living with moderate-to-severe atopic dermatitis and is working to enable broad first-line biologic access to EBGLYSS for patients not well controlled with topical prescription therapy through commercial insurance. Lilly has coverage with all three major national pharmacy benefit managers and 94% of commercially insured patients have coverage through national health plans. We have expanded Medicaid coverage and are pursuing similarly broad Medicare coverage as part of Lilly's health equity and affordability initiative. Through Lilly Support Services, Lilly offers a patient support program including co-pay assistance for eligible, commercially insured patients.
INDICATION AND SAFETY SUMMARY
EBGLYSS® (EHB-glihs) is an injectable medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. EBGLYSS can be used with or without topical corticosteroids.
It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg).
Warnings - Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients.
Before using
Before using EBGLYSS, tell your healthcare provider about all your medical conditions, including if you:
- Have a parasitic (helminth) infection.
- Are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with EBGLYSS.
- Are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby. If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy.
- Are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Possible side effects
EBGLYSS can cause serious side effects, including:
- Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms:
- breathing problems or wheezing
- swelling of the face, lips, mouth, tongue or throat
- hives
- itching
- fainting, dizziness, feeling lightheaded
- skin rash
- cramps in your stomach area (abdomen)
- Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision.
The most common side effects of EBGLYSS include:
- eye and eyelid inflammation, including redness, swelling, and itching
- injection site reactions
- shingles (herpes zoster)
These are not all of the possible side effects of EBGLYSS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
How to take
- See the detailed "Instructions for Use" that comes with EBGLYSS for information about how to prepare and inject EBGLYSS and how to properly store and throw away (dispose of) used EBGLYSS prefilled pens and prefilled syringes.
- Use EBGLYSS exactly as prescribed by your healthcare provider.
- EBGLYSS is given as an injection under the skin (subcutaneous injection).
- If your healthcare provider decides that you or a caregiver can give the injections of EBGLYSS, you or a caregiver should receive training on the right way to prepare and inject EBGLYSS. Do not try to inject EBGLYSS until you have been shown the right way by your healthcare provider. In children 12 years of age and older, EBGLYSS should be given by a caregiver.
- If you miss a dose of EBGLYSS, inject the missed dose as soon as possible, then inject your next dose at your regular scheduled time.
Learn more
EBGLYSS is a prescription medicine available as a 250 mg/2 mL injection prefilled pen or prefilled syringe. For more information, call 1-800-545-5979 or go to ebglyss.lilly.com
This summary provides basic information about EBGLYSS but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking to your doctor. Be sure to talk to your doctor or other healthcare provider about EBGLYSS and how to take it. Your doctor is the best person to help you decide if EBGLYSS is right for you.
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EBGLYSS®, its delivery device base, and Lilly Support Services are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY
Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
Cautionary Statement Regarding Forward-Looking Statements?
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about EBGLYSS (lebrikizumab-lbkz) as a treatment for patients with moderate-to severe atopic dermatitis and the timeline for future readouts, presentations, and other milestones relating to EBGLYSS and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with the results to date or that EBGLYSS will receive additional regulatory approvals, or that it will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
1 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. American Academy of Dermatology Annual Meeting. March 2026
2 Simpson EL, et al. Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE). J Am Acad Dermatol. 2018;78(5):863-871.e11. doi:10.1016/j.jaad.2018.01.017
3 Okragly A, et al. Binding, Neutralization and Internalization of the Interleukin-13 Antibody, Lebrikizumab. Dermatol Ther (Heidelb). 2023;13(7):1535-1547. doi:10.1007/s13555-023-00947-7
4 Ultsch M, et al. Structural basis of signaling blockade by anti-IL-13 antibody Lebrikizumab. J Mol Biol. 2013;425(8):1330-1339. doi:10.10116/j.jmb.2013.01.024
5 Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54-62. doi:10.1111/all.13954
6 Tsoi LC, et al. Atopic Dermatitis Is an IL-13-Dominant Disease with Greater Molecular Heterogeneity Compared to Psoriasis. J Invest Dermatol. 2019;139(7):1480-1489. doi:10.1016/j.jid.2018.12.018
7 Merola J, et al. Patients with Atopic Dermatitis with a Stable Response to Lebrikizumab Flare Less in a Long-Term Study: A Post-hoc Analysis of the ADjoin Study. Maui Derm Hawaii. January 2026
8 EBGLYSS. Prescribing Information. Lilly USA, LLC.
Refer to: | Kelly Hoffman; [email protected]; 765-736-2555 (Lilly media) |
Michael Czapar; [email protected]; 317-617-0983 (Investors) |
SOURCE Eli Lilly and Company
