New data show Lilly's EBGLYSS™ (lebrikizumab-lbkz) provided sustained disease control for up to three years in more than 80% of adults and adolescents with moderate-to-severe atopic dermatitis
Eli Lilly and Company (NYSE: LLY) announced new long-term results for EBGLYSS™ (lebrikizumab-lbkz) in treating moderate-to-severe atopic dermatitis. The data, from the ADjoin long-term extension study, will be presented at the European Academy of Dermatology and Venereology Congress.
Key findings include:
- Over 80% of adults and adolescents who responded to EBGLYSS at Week 16 maintained clear or almost-clear skin for up to three years with monthly maintenance dosing.
- 84% of patients on monthly dosing and 83% on bi-weekly dosing maintained clear or almost-clear skin (IGA 0,1) at three years.
- 87% of monthly dosing patients and 79% of bi-weekly dosing patients achieved or maintained at least 90% improvement in disease extent and severity (EASI-90) at three years.
- The safety profile remained consistent with previous studies, with no new safety signals observed.
EBGLYSS, an IL-13 inhibitor, was recently approved by the FDA and is also approved in the EU and Japan.
Eli Lilly and Company (NYSE: LLY) ha annunciato nuovi risultati a lungo termine per EBGLYSS™ (lebrikizumab-lbkz) nel trattamento della dermatite atopica da moderata a severa. I dati, provenienti dallo studio di estensione a lungo termine ADjoin, saranno presentati al Congresso dell'Accademia Europea di Dermatologia e Venereologia.
I risultati chiave includono:
- Oltre l'80% degli adulti e degli adolescenti che hanno risposto a EBGLYSS nella Settimana 16 ha mantenuto una pelle chiara o quasi chiara per un massimo di tre anni con dosaggio di mantenimento mensile.
- Il 84% dei pazienti in trattamento mensile e l'83% di quelli in trattamento bisettimanale hanno mantenuto una pelle chiara o quasi chiara (IGA 0,1) dopo tre anni.
- Il 87% dei pazienti in trattamento mensile e il 79% di quelli in trattamento bisettimanale hanno raggiunto o mantenuto almeno il 90% di miglioramento nell'estensione e nella severità della malattia (EASI-90) dopo tre anni.
- Il profilo di sicurezza è rimasto coerente con studi precedenti, senza nuovi segnali di sicurezza osservati.
EBGLYSS, un inibitore dell'IL-13, è stato recentemente approvato dalla FDA ed è anche approvato nell'UE e in Giappone.
Eli Lilly and Company (NYSE: LLY) anunció nuevos resultados a largo plazo para EBGLYSS™ (lebrikizumab-lbkz) en el tratamiento de la dermatitis atópica de moderada a severa. Los datos, provenientes del estudio de extensión a largo plazo ADjoin, serán presentados en el Congreso de la Academia Europea de Dermatología y Venereología.
Los hallazgos clave incluyen:
- Más del 80% de los adultos y adolescentes que respondieron a EBGLYSS en la Semana 16 mantuvieron la piel clara o casi clara durante hasta tres años con tratamiento de mantenimiento mensual.
- El 84% de los pacientes con dosificación mensual y el 83% con dosificación quincenal mantuvieron la piel clara o casi clara (IGA 0,1) a los tres años.
- El 87% de los pacientes con dosificación mensual y el 79% de los pacientes con dosificación quincenal lograron o mantuvieron al menos un 90% de mejora en la extensión y severidad de la enfermedad (EASI-90) a los tres años.
- El perfil de seguridad se mantuvo consistente con estudios anteriores, sin nuevos señales de seguridad observadas.
EBGLYSS, un inhibidor de IL-13, fue recientemente aprobado por la FDA y también está aprobado en la UE y Japón.
엘리 릴리(Eli Lilly and Company) (NYSE: LLY)는 중증 아토피 피부염 치료를 위한 EBGLYSS™ (레브리키주맙-lbkz)에 대한 새로운 장기 결과를 발표했습니다. 이 데이터는 ADjoin 장기 확장 연구에서 나온 것이며, 유럽 피부과 및 성병학 아카데미 Congress에서 발표될 예정입니다.
주요 발견은 다음과 같습니다:
- EBGLYSS에 반응한 성인 및 청소년의 80% 이상이 16주차에서 3년 동안 월간 유지 요법으로 맑거나 거의 맑은 피부를 유지했습니다.
- 월간 복용 환자의 84%와 격주 복용 환자의 83%가 3년 후에 맑거나 거의 맑은 피부(IGA 0,1)를 유지했습니다.
- 월간 복용 환자의 87%와 격주 복용 환자의 79%가 3년 후 질병 범위 및 중증도가 90% 이상 개선된 것을 달성하거나 유지했습니다 (EASI-90).
- 안전성 프로파일은 이전 연구와 일관되며, 새로운 안전성 신호는 관찰되지 않았습니다.
EBGLYSS는 IL-13 억제제로, 최근 FDA의 승인을 받았고 EU 및 일본에서도 승인되었습니다.
Eli Lilly and Company (NYSE: LLY) a annoncé de nouveaux résultats à long terme pour EBGLYSS™ (lebrikizumab-lbkz) dans le traitement de la dermatite atopique modérée à sévère. Les données, issues de l'étude d'extension à long terme ADjoin, seront présentées au Congrès de l'Académie Européenne de Dermatologie et de Vénéréologie.
Les principales conclusions incluent :
- Plus de 80 % des adultes et des adolescents ayant répondu à EBGLYSS à la Semaine 16 ont maintenu une peau claire ou presque claire pendant jusqu'à trois ans avec un traitement d'entretien mensuel.
- 84 % des patients sous traitement mensuel et 83 % sous traitement bi-hebdomadaire ont maintenu une peau claire ou presque claire (IGA 0,1) après trois ans.
- 87 % des patients sous traitement mensuel et 79 % des patients sous traitement bi-hebdomadaire ont atteint ou maintenu au moins 90 % d'amélioration dans l'extension et la gravité de la maladie (EASI-90) après trois ans.
- Le profil de sécurité est resté cohérent avec les études précédentes, sans nouveaux signaux de sécurité observés.
EBGLYSS, un inhibiteur de l'IL-13, a été récemment approuvé par la FDA et est également approuvé dans l'UE et au Japon.
Eli Lilly and Company (NYSE: LLY) hat neue Langzeitergebnisse für EBGLYSS™ (Lebrikizumab-lbkz) bei der Behandlung von moderater bis schwerer atopischer Dermatitis angekündigt. Die Daten stammen aus der ADjoin-Langzeitstudie und werden auf dem Kongress der Europäischen Akademie für Dermatologie und Venerologie präsentiert.
Wichtige Erkenntnisse sind:
- Mehr als 80 % der Erwachsenen und Jugendlichen, die in Woche 16 auf EBGLYSS reagierten, hielten für bis zu drei Jahre mit monatlicher Erhaltungsdosis eine klare oder fast klare Haut.
- 84 % der Patienten mit monatlicher Dosis und 83 % mit alle zwei Wochen Dosis hielten nach drei Jahren eine klare oder fast klare Haut (IGA 0,1).
- 87 % der Patienten mit monatlicher Dosis und 79 % der Patienten mit alle zwei Wochen Dosis erreichten oder hielten mindestens 90 % Verbesserung in Ausmaß und Schwere der Erkrankung (EASI-90) nach drei Jahren.
- Das Sicherheitsprofil blieb konstant zu früheren Studien, ohne neue Sicherheitszeichen festgestellt.
EBGLYSS, ein IL-13-Inhibitor, wurde kürzlich von der FDA genehmigt und ist auch in der EU und Japan zugelassen.
- Over 80% of patients maintained clear or almost-clear skin for up to three years with monthly maintenance dosing
- 87% of patients on monthly dosing achieved or maintained at least 90% improvement in disease extent and severity at three years
- Nearly 87% of patients did not require high-potency topical corticosteroids or systemic treatments during the three-year study
- Safety profile at three years was consistent with previously published two-year results, with no new safety signals observed
- EBGLYSS recently approved by FDA, EU, and Japan, with additional markets expected later this year
- Less than 3% of patients experienced adverse events leading to treatment discontinuation
- Most common side effects included conjunctivitis, injection site reactions, and shingles (herpes zoster)
Insights
The three-year data for EBGLYSS (lebrikizumab) in treating moderate-to-severe atopic dermatitis is highly significant. Key findings include:
- Sustained efficacy: Over
80% of responders maintained clear or almost-clear skin for up to 3 years with monthly dosing. - High response rates:
84% on monthly dosing and83% on bi-weekly dosing maintained IGA 0,1 scores at 3 years. - Reduced need for additional treatments:
87% of monthly dosed patients didn't require high-potency topical corticosteroids or systemic treatments. - Consistent safety profile: No new safety signals observed over 3 years, with most adverse events being mild to moderate.
These results demonstrate EBGLYSS's potential as a long-term treatment option for atopic dermatitis, offering durable efficacy and a favorable safety profile. The data supports its recent FDA approval and could strengthen its market position against competitors like Dupixent.
The positive long-term data for EBGLYSS has significant implications for Eli Lilly (LLY):
- Market potential: With sustained efficacy and safety over 3 years, EBGLYSS could capture a substantial share of the growing atopic dermatitis market, estimated to reach
$24 billion by 2027. - Competitive advantage: The long-term data may differentiate EBGLYSS from competitors, potentially leading to increased market share and revenue growth.
- Revenue stream: As a chronic treatment, EBGLYSS could provide a steady, long-term revenue source for Lilly.
- Global expansion: Recent approvals in the U.S., EU and Japan, with more markets expected, indicate strong global growth potential.
Investors should monitor EBGLYSS's market penetration and sales performance in the coming quarters, as it could become a significant driver for Lilly's future growth and stock performance.
Monthly EGBLYSS maintenance dosing sustained clear or almost-clear skin for up to three years in the vast majority of ADvocate 1 and 2 responders
Nearly 87 percent of patients taking EBGLYSS did not require either high-potency topical corticosteroids or systemic treatments during the three-year study
The safety profile at three years was consistent with the previously published two-year results
EBGLYSS is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity.2,3,4 The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.5,6
"The chronic and persistent signs and symptoms of atopic dermatitis affect patients' daily lives, highlighting the need for a treatment that can provide sustained, long-term relief," said Eric Simpson, M.D., M.C.R., professor of dermatology and director of clinical research at Oregon Health & Science University School of Medicine in
Patients taking EBGLYSS who completed 52 weeks in ADvocate 1 or 2 could enroll in ADjoin for an additional 100 weeks of continued treatment (up to 152 weeks of continuous treatment). Patients in this analysis of the long-term extension trial received treatment either 250 mg every two weeks (Q2W) or once monthly (Q4W). The approved maintenance dose of EBGLYSS is 250 mg Q4W. These data presented are part of ADjoin, the long-term extension study of the EBGLYSS trials, and include participants who responded to EBGLYSS treatment at Week 16 from ADvocate 1 and ADvocate 2. 1
- 84 percent of these patients taking EBGLYSS once monthly and 83 percent taking EBGLYSS every two weeks maintained clear or almost-clear skin (IGA 0,1) at three years.1
- 87 percent of these patients taking EBGLYSS once monthly and 79 percent taking EBGLYSS every two weeks achieved or maintained at least 90 percent improvement in disease extent and severity (EASI-90) at three years.1
- 83 percent of these patients taking EBGLYSS once monthly and 91 percent taking EBGLYSS every two weeks did not require either high-potency topical corticosteroids or systemic treatments.1
The safety profile of these patients taking EBGLYSS in ADjoin was consistent with previous EBGLYSS studies, and no new safety signals were observed up to three years of treatment. The majority of adverse events were mild or moderate. Less than three percent of patients experienced adverse events leading to treatment discontinuation. The most common side effects of EBGLYSS were conjunctivitis, injection site reactions and shingles (herpes zoster).1
"Without adequate treatment, atopic dermatitis can leave people struggling with uncontrolled symptoms," said Mark Genovese, M.D., senior vice president of Immunology Development at Lilly. "EBGLYSS selectively targets IL-13, one of the main drivers of inflammation in eczema. These three-year data demonstrate that EBGLYSS given once monthly provides durable symptom relief for patients who need it most."
Additional data from this clinical study is underway, with results to be presented at future congresses.
EBGLYSS was approved in the
"These latest clinical data for EBGLYSS show the potential of this innovative medicine to provide sustained improvement of moderate-to-severe atopic dermatitis, a chronic and often debilitating condition," said Volker Koscielny, M.D., Chief Medical Officer at Almirall. "The data can help inform clinical decision-making and are reassuring, as they show that the vast majority of patients who respond to the treatment will continue to respond over time."
Lilly has exclusive rights for development and commercialization of EBGLYSS in the
About ADjoin
ADjoin (NCT04392154) evaluated the long-term safety and efficacy of EBGLYSS treatment in patients with moderate-to-severe atopic dermatitis for up to 100 weeks (up to 152 weeks of continuous treatment with the parent studies). Patients taking EBGLYSS who completed any of the parent studies (ADvocate 1 and 2, ADhere, ADore, ADopt-VA) were able to enroll in ADjoin. The ADhere parent study includes patients taking topical corticosteroids with EBGLYSS as a combination therapy. Patients could also enroll directly into ADjoin without participating in a parent study. Patients in this analysis of the long-term extension trial received either EBGLYSS 250 mg every two weeks or once monthly.1
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
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
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
- itching
- swelling of the face, lips, mouth, tongue or throat
- fainting, dizziness, feeling lightheaded
- skin rash
- hives
- 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.
LK CON BS AD APP
EBGLYSS™ and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
About EBGLYSS
EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate.3,4,7 EBGLYSS binds to the IL-13 cytokine at an area that overlaps with the binding site of the IL-4Rα subunit of the IL-13Rα1/IL-4Rα heterodimer, preventing formation of this receptor complex and inhibiting IL-13 signaling.5 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-13.7
The EBGLYSS Phase 3 program consists of five key global studies evaluating over 1,300 patients, including two monotherapy studies (ADvocate 1 and 2), a combination study with topical corticosteroids (ADhere), as well as long-term extension (ADjoin) and adolescent open label (ADore) studies. Further data results from ADmirable and ADapt are expected to be shared in 2024 and early 2025.
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 more than 51 million 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
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 Thaci E, et al. Efficacy and Safety of Lebrikizumab is Maintained up to Three Years in Patients with Moderate-to-Severe Atopic Dermatitis: ADvocate 1, ADvocate 2, and ADjoin Long Term Extension Trial. 2024 European Academy of Dermatology and Venereology Congress. September 25, 2024.
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 EBGLYSS. Prescribing Information. Lilly
Refer to: | Rachel Hoffmeyer; rachel.hoffmeyer@lilly.com; +1-463-276-8558 (Media) |
Joe Fletcher; jfletcher@lilly.com; +1-317-296-2884 (Investors) |
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FAQ
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