11/17/2025 | Estadão Communication Agency | PRNewswire

https://bluestudio.estadao.com.br/agencia-de-comunicacao/prnewswire/ans-abre-consulta-publica-para-decidir-sobre-a-inclusao-de-novo-medicamento-para-dermatite-atopica/ 

Lebriquizumab was approved by ANVISA for severe cases of the disease.

The public consultation is a stage of social participation in which people living with atopic dermatitis, healthcare professionals, and family members can contribute by giving their opinions regarding the availability of the treatment through health plans. Until November 24th, it is possible to participate through the ANS website.

Atopic dermatitis (AD) is a chronic, immune-mediated, and debilitating disease that has physical, psychological, and socioeconomic impacts on the lives of patients and their families. These impacts include sleep disorders, anxiety, depression, and impairments in quality of life, productivity at work/school, and social activities[1],[2],[3]. Intense itching occurs in most patients with AD and is considered the most disabling symptom of the disease. Daily itching is present in more than 85% of patients with severe atopic dermatitis, and 42% report itching for more than 18 hours a day.3 Skin pain is present in 60% of adults with atopic dermatitis and may be associated with itching, excoriations, fissures, and possibly a neuropathic component1. Individualized care for a chronic and debilitating disease demands effective and sustainable therapeutic alternatives over time, and even with an extensive therapeutic arsenal, a significant portion of the population still has difficulty keeping the disease under control in the long term. [4],[5]

To decide on the inclusion of the treatment in the coverage list, the National Health Agency (ANS) opens Public Consultation No. 163/2025 this Wednesday, November 5, 2025.[6] Participation is free and voluntary and open to all of society, allowing each citizen to express their opinion on the subject. Simply access the ANS website to access the informational materials and register your opinion. Based on the technical documentation and public collaboration, the agency will decide whether or not health plans should start providing the medication for adults with severe Alzheimer's disease who experience failure, intolerance, or contraindication to cyclosporine, when prescribed by a doctor.

Lebriquizumab, from Lilly, is a monoclonal antibody that has demonstrated efficacy in treating adults with severe atopic dermatitis who have failed or are intolerant to cyclosporine, showing a favorable safety profile and no significant increase in adverse events. Patients in clinical trials showed a reduction in pruritus (itching) and significant improvements in skin lesions and quality of life, compared to placebo[7],[8].

“Studies show that this is a medication that can contribute to the physical and psychosocial health of people impacted by this disease, which goes far beyond skin lesions. Severe cases, if not adequately treated, increase the risk of skin and systemic infections, as well as greater demand for care and hospitalizations. Furthermore, as this is a cost-minimizing alternative, we can also consider more efficient investments in the supplementary health system. Within this clinical and structural context, participation in the public consultation is important and can help expand access to innovative therapies,” says Luiz André Magno, senior director of Eli Lilly Brazil.

While mild atopic dermatitis can be controlled with topical treatments such as ointments, severe atopic dermatitis often necessitates the inclusion of systemic medications such as immunosuppressants, including cyclosporine, in the treatment regimen.[9],[10],[11] Currently, the ANS (Brazilian National Agency for Supplementary Health) only includes one option for patients who do not respond adequately to cyclosporine.

About Atopic Dermatitis

AD is a chronic, relapsing inflammatory skin disease whose main symptom is intense itching. It is a multifactorial disease, meaning it is frequently associated with a genetic component, environmental factors – such as climate – and immunological predisposition, characteristic of inflammatory diseases such as allergic rhinitis and asthma.[12][13][14][15] The prevalence of the disease in the Brazilian population is estimated to be 2.7%, with 8.3% of cases diagnosed as severe.[16]

Patients with severe and active disease have poorer sleep quality, leading to daytime fatigue, mood changes, and impaired school or work performance. Worsening sleep appears to be strongly related to itching and scratching, which intensify at night and are more difficult to control during this period.[4],[5],[6]

About Ebglyss™

Ebglyss™ was approved by Anvisa in October 2024 for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older, based on the results of three phase 3 clinical studies, ADvocate 1, ADvocate 2, and ADhere, which included more than 1000 patients.[17]

The drug is a monoclonal antibody that targets the inhibition of interleukin IL-13, responsible for the inflammation that results in the classic symptoms of the disease, such as reddish or dark patches, itching, and dryness.[18][19][20][21] The 250 mg/2 mL injection can be used with or without topical corticosteroids and is administered as a single monthly maintenance injection of 250 mg every four weeks after the treatment induction period. [19]

About ADvocate 1 and ADvocate 2

ADvocate 1 and ADvocate 2 are 52-week, randomized, double-blind, placebo-controlled, parallel-group, global, Phase 3 studies designed to evaluate EBGLYSS as monotherapy in adults and children (aged 12 to less than 18 years and weighing at least 40 kg) with severe atopic dermatitis.[8],[9]

During the 16-week treatment induction period, patients received Ebglyss™ 500 mg initially and at two weeks, followed by Ebglyss™ 250 mg or placebo every two weeks. During the maintenance period, patients with severe atopic dermatitis who achieved a clinical response at 16 weeks of treatment with Ebglyss™ were re-randomized to receive Ebglyss™ every two weeks or four weeks or placebo for a further 36 weeks. Patients who required rescue treatment during the induction period or who did not meet the protocol-defined response criteria at 16 weeks were transferred to the open-label treatment arm of the study and received Ebglyss™ every two weeks for a further 36 weeks.[8],[9]

The primary outcome was measured by an Investigator Global Assessment (IGA) score of lesion-free (0) or nearly lesion-free (1) skin with a reduction of at least two points from baseline at 16 weeks. Key secondary outcomes were measured by the Eczema Area and Severity Index (EASI) and the Pruritus Numeric Rating Scale (NRS). The EASI measures the extent and severity of the disease, and the NRS measures the intensity of itching.[8],[9]

About ADhere

ADhere is a randomized, double-blind, placebo-controlled, parallel-group, global, 16-week Phase 3 randomized study to evaluate the efficacy and safety of Ebglyss™ in combination with topical corticosteroids (TCs) initiated in 211 adults and children (aged 12 to less than 18 years and weighing at least 40 kg) with severe atopic dermatitis. In the study, patients' baseline atopic dermatitis symptoms were inadequately controlled by TCs with or without topical calcineurin inhibitors (CAIs). The study was designed to be more consistent with clinical practice where patients received medium-potency CTs (0.1% triamcinolone acetonide cream) or low-potency CTs (1% hydrocortisone cream, for use on sensitive skin areas), which could be tapered, interrupted, or resumed at the patient's discretion.[22]

About Eli Lilly Brazil?

Lilly is a medical company that transforms science into healing to improve the lives of people around the world. We have been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people worldwide. By harnessing the power of biotechnology, chemistry, and genetic medicine, we continue to advance new discoveries to solve some of the world's most important health challenges: redefining diabetes treatment; treating obesity and reducing its devastating long-term effects; advancing the fight against Alzheimer's disease; and providing solutions for some of the most debilitating immune system disorders. ...and transform the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we are motivated by one thing: improving the lives of millions of people. This includes conducting innovative clinical studies that reflect the diversity of our world and working to ensure that our medicines are more accessible to patients. To learn more, visit the Lilly do Brasil website and our social media: Instagram, Facebook, and LinkedIn.

CMAT-01943 – November 2025
Material intended for the general public

References:

[1] Ring J, Zink A, Arents BWM, et al. Atopic eczema: burden of disease and individual suffering – results from a large EU study in adults. J Eur Acad Dermatol Venereol. Jul 2019;33(7):1331-1340. doi:10.1111/jdv.15634

[2] Silverberg JI, Gelfand JM, Margolis DJ, et al. Patient burden and quality of life in atopic dermatitis in US adults: A population-based cross-sectional study. Ann Allergy Asthma Immunol. Sep 2018;121(3):340-347. doi:10.1016/j.anai.2018.07.006

[3] Simpson EL, Bieber T, Eckert L, et al. Patient burden of moderate to severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults. J Am Acad Dermatol. Mar 2016;74(3):491-8. doi:10.1016/j.jaad.2015.10.043

[4] Lobefaro F, et al. Biomedicines. 2022;10(11):2927.

[5] Puar N, et al. Ann Allergy Asthma Immunol. 2021;126:21-31

[6] BRAZIL. National Supplementary Health Agency. Technical Note nº 46/2025/GCITS/GGRAS/DIRAD-DIPRO/DIPRO. Rio de Janeiro: ANS, 2025. Available at: https://componentes-portal.ans.gov.br/link/ConsultaPublica/163. Accessed on: 5 Nov. 2025.

[7] Silverberg, et al. Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis. N Engl J Med 2023; 388:1080-1091. DOI: 10.1056/NEJMoa2206714

[8] Blauvelt A, Thyssen JP, Guttman-Yassky E, et al. Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: 52-week results of two randomized double-blinded placebo-controlled phase III trials. Br J Dermatol. 2023 May 24;188(6):740-748.

[9] Prado E, Pastorino AC, Harari DK, et al. Severe atopic dermatitis: practical treatment guide from the Brazilian Association of Allergy and Immunology and the Brazilian Society of Pediatrics. Arq Asma Alerg Imunol. 2022;6(4):462-67. doi: http://dx.doi.org/10.5935/2526-5393.20220053 – Accessed on 10/14/2025

[10] Orfali RL, Lorenzini D, Bressan A, et al. Consensus on the therapeutic management of atopic dermatitis – Brazilian Society of Dermatology: update on phototherapy and systemic therapy using the e-Delphi method. 10.1016/j.abdp.2023.05.021. Brazilian Annals of Dermatology (Portuguese). 2023;98(6):814-836. doi:10.1016/j.abdp.2023.05.021

[11] Wollenberg A, Kinberger M, Arents B, et al. European guideline (EuroGuiDerm) on atopic eczema – part II: non-systemic treatments and treatment recommendations for special AE patient populations. J Eur Acad Dermatol Venereol. Nov 2022;36(11):1904-1926. doi:10.1111/jdv.18429

[12] Spergel JM. From atopic dermatitis to asthma: the atopic march. Ann Allergy Asthma Immunol. Aug 2010;105(2):99-106; quiz 107-9, 117. doi:10.1016/j.anai.2009.10.002

[13] Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. Feb 2014;70(2):338-51. doi:10.1016/j.jaad.2013.10.010

[14] Schram ME, Tedja AM, Spijker R, Bos JD, Williams HC, Spuls PI. Is there a rural/urban gradient in the prevalence of eczema? A systematic review. Br J Dermatol. May 2010;162(5):964-73. doi:10.1111/j.1365-2133.2010.09689.x

[15] Williams H, Flohr C. How epidemiology has challenged 3 prevailing concepts about atopic dermatitis. J Allergy Clin Immunol. Jul 2006;118(1):209-13. doi:10.1016/j.jaci.2006.04.043

[16] Pontes LM SN, de Souza MLP, Alves AFV, Amarante MS de LD, Silva PRS e, Brandão BJF. Epidemiological profile of patients diagnosed with atopic dermatitis treated at the dermatology service. BWS Journal. 2020;3(0):1-6.

[17] Official Gazette of the Union – Anvisa Regulatory Approval – Available at https://www.in.gov.br/en/web/dou/-/resolucao-re-n-3.952-de-24-de-outubro-de-2024-592775888 – Accessed on 10/14/2025

[18] 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

[19] Ultsch M, et al. Structural basis of signaling blockade by anti-IL-13 antibody Lebrikizumab. J Mol Biol. 2013;425(8):1330-1339. doi:10.1016/j.jmb.2013.01.024

[20] Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergies. 2020;75(1):54-62. doi:10.1111/all.13954

[21] 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

[22] Simpson EL, Bruin-Weller M, Hong CH, et al. Lebrikizumab Provides Rapid Clinical Responses Across All Eczema Area and Severity Index Body Regions and Clinical Signs in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis Dermatol Ther (Heidelb) (2024) 14: 1145-1160

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SOURCE Eli Lilly do Brasil