"Abrocitinib"

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                            1
                            2024NIHR HTA programme
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                            Abrocitinib, tralokinumab and upadacitinib for treating moderate-to-severe atopic dermatitis Abrocitinib, tralokinumab and upadacitinib for treating moderate-to-severe atopic dermatitis * Text only * * Home * Journals * * Other NIHR research * * For authors * For reviewers * About * Policies * * Accessibility * Journals LibraryNHS NIHR - National Institute for Health Research Select EME GHR
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                            2023Institute for Quality and Efficiency in Healthcare (IQWiG)
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                            Abrocitinib (atopic dermatitis, adolescents 12 years and older) ' Benefit assessment according to ' 35a Social Code Book V 1 Translation of Sections I 1 to I 6 of the dossier assessment Abrocitinib (atopische Dermatitis bei Jugendlichen ≥ 12 Jahre) – Nutzenbewertung gemäß § 35a SGB V. Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Abrocitinib (atopic dermatitis in adolescents ≥ 12 years) Benefit assessment according to §35a SGB V1 EXTRACT Project: A24-45 Version: 1.0 Status: 26 Jul 2024 DOI: 10.60584/A24-45_en Extract of dossier assessment A24-45 Version 1.0 Abrocitinib ( atopic dermatitis in adolescents ≥ 12 years
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                            Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis Technology appraisal guidance Published: 3 August 2022 www.nice.org.uk/guidance/ta814 © NICE 2022. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of-rights and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis (TA814)© NICE 2022. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of-rights).Page 2 of28Contents Contents 1 Recommendations
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                            Abrocitinib (Cibinqo) Skip to main contentSwitch to basic HTML versionLanguage selectionFrançaisSearchSearch Canada.caSearchTopics menuMAINMENU You are here:Home Health Drug and health products Licensing, authorizing and manufacturing drug and health products Drug and health product review and approval Clinical information on drugs and health products Search for clinical information on drugs
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                            2024Appropriate Care Guides, Agency for Care Effectiveness (Singapore)
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                            Abrocitinib, baricitinib, upadacitinib and dupilumab for treating atopic dermatitis Published: 2 January 2024 Driving Better Decision-Making in Healthcare Page 1 Abrocitinib, baricitinib, upadacitinib and dupilumab for treating atopic dermatitis Technology Guidance from the MOH Drug Advisory Committee Guidance Recommendations The Ministry of Health’s Drug Advisory Committee has recommended:  Abrocitinib 50 mg, 100 mg and 200 mg film-coated tablets for treating moderate-to-severe atopic dermatitis in patients who have had an inadequate response, intolerance or contraindication to at least one systemic therapy such as ciclosporin, methotrexate, azathioprine and mycophenolate mofetil. Funding status Abrocitinib 50 mg, 100 mg and 200 mg film-coated tablets
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                            2022Institute for Quality and Efficiency in Healthcare (IQWiG)
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                            Abrocitinib (atopic dermatitis) - Benefit assessment according to '35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Abrocitinib (atopische Dermatitis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 April 2022). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A22-06 Abrocitinib (atopic dermatitis) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A22-06 Version 1.0 Abrocitinib (atopic dermatitis) 13 April 2022 Institute for Quality and Efficiency
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                            2022Institute for Quality and Efficiency in Healthcare (IQWiG)
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                            Abrocitinib (atopic dermatitis) - Addendum to Commission A22-06 1 Translation of addendum A22-60 Abrocitinib (atopische Dermatitis) – Addendum zum Auftrag A22-06 (Version 1.0; Status: 10 June 2022). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However , solely the German original text is absolutely authoritative and legally binding. Addendum 10 June 2022 1.0 Commission: A22-60 Version: Status: IQWiG Reports – Commission No. A22-60 Abrocitinib (atopic dermatitis) – Addendum to Commission A22-061 Addendum A22-60 Version 1.0 Abrocitinib – Addendum to Commission A22-06 10 June 2022 Institute for Quality and Efficiency in Health Care (IQWiG) - i
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                            2022FDA - Drug Approval Package
                            Abrocitinib (Cibinqo) - To treat refractory, moderate-to-severe atopic dermatitis Drug Approval Package: CIBINQO * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices
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                            2023CADTH - Reimbursement Review
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                            Abrocitinib (Cibinqo) - Atopic dermatitis View of Abrocitinib (Cibinqo) | Canadian Journal of Health TechnologiesReturn to Article DetailsAbrocitinib (Cibinqo)
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                            2021European Medicines Agency - EPARs
                            Abrocitinib (Cibinqo) - atopic dermatitis Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. EMA/700036/2021 EMEA/H/C/005452 Cibinqo (abrocitinib) An overview of Cibinqo and why it is authorised in the EU What is Cibinqo and what is it used for? Cibinqo is a medicine for treating adults with moderate to severe atopic dermatitis (also known as eczema, when the skin is itchy, red and dry). It is used in patients for whom treatment applied directly to the skin cannot
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                            2022Scottish Medicines Consortium
                            Abrocitinib (Cibinqo) - atopic dermatitis 1 Published 13 June 2022 1 SMC2431 abrocitinib 50mg, 100mg, and 200mg film-coated tablets (Cibinqo®) Pfizer Ltd 06 May 2022 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC Executive, advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission abrocitinib (Cibinqo®) is accepted for restricted use within NHSScotland. Indication under review: for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. SMC restriction: for use in patients who have not responded to, or have lost
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                            Blood transcriptome signature as indicator and predictor for efficacy of abrocitinib in treatment of atopic dermatitis. Atopic dermatitis (AD) patients exhibit significant blood transcriptome alterations, reflecting systemic inflammation. The effects of abrocitinib, a Janus kinase 1 inhibitor, on the blood transcriptome of AD remain unclear. This study aim to investigate abrocitinib's effects on the blood transcriptome in AD patients and identify transcriptomic predictors of treatment efficacy. Blood cell mRNA sequencing was conducted on 31 AD patients at baseline, 4, and 12 weeks of 100 mg abrocitinib daily treatment. Differential gene expression, immune infiltration, and weighted gene co-expression network analyses (WGCNA) were performed, along with correlation analysis of transcriptomic data
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                            2025Allergy
                            Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis. Abrocitinib has demonstrated long-term efficacy (48 weeks) and safety (~4 years) in adults and adolescents with moderate-to-severe atopic dermatitis (AD). This analysis evaluated abrocitinib efficacy in adolescents through 112 weeks, and safety of up to 4.6 years of exposure. Data and Severity Index (EASI-75/-90). Treatment-emergent adverse events (TEAEs) and AEs of special interest were reported as incidence rate/100 patient-years. A substudy of JADE TEEN assessed immune response to vaccination. Efficacy was assessed in 170 and 187 patients in the abrocitinib 200-mg and 100-mg arms, respectively; median exposure was 971.0 and 899.0 days. At Week 112, comparable proportions
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                            2025Allergy
                            Real-World Efficacy and Safety of Abrocitinib in Chinese Atopic Dermatitis Patients: A Single-Center Prospective Study. Phase 3 trials have demonstrated the efficacy and safety of abrocitinib for atopic dermatitis (AD), but real-world evidence remains limited. This study prospectively enrolled 117 moderate-to-severe AD patients at Huashan Hospital, Shanghai, China. Physician- and patient -reported outcomes were evaluated at multiple time points. Blood eosinophil counts, serum IgE, and 24 cytokines/chemokines were measured. Abrocitinib treatment led to rapid and potent improvements in disease severity. At week 12, 74.3% and 50.5% of AD patients achieved at least 75% and 90% improvement in the eczema area and severity index (EASI), respectively. Compared to dupilumab, abrocitinib showed
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                            Abrocitinib alleviates the symptoms of Netherton syndrome and is well tolerated. To investigate the potential genetic basis of Netherton syndrome (NS) through first- and second-generation DNA sequencing techniques. Additionally, we evaluated the therapeutic efficacy of Abrocitinib in NS patients. We conducted whole-exome sequencing analysis on a pedigree comprising one affected individual with NS. Subsequently, the identified patient was treated with Abrocitinib, and clinical improvements in cutaneous manifestations were systematically assessed. Genetic analysis revealed that the patient harbored compound heterozygous mutations in the SPINK5 gene, including a missense mutation in exon 26 (c.2475G > T, p.Trp825Cys). Following six months of Abrocitinib therapy, the patient exhibited marked
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                            Abrocitinib versus dupilumab: impact on skin barrier function and proteomics in atopic dermatitis. The comparative impact of dupilumab and abrocitinib on skin barrier function and associated proteomics in atopic dermatitis (AD) remains not fully identified. To investigate the effects of dupilumab versus abrocitinib on skin barrier function and proteomic profiles in AD. In this study, 33 patients with moderate-to-severe AD were randomized into two groups: 16 received dupilumab and 17 received abrocitinib. Clinical outcomes and skin barrier parameters (transepidermal water loss [TEWL] and hydration) were assessed at baseline, 4 weeks, and 12 weeks. Skin tape strips were collected for four-dimensional data-independent acquisition-based proteomics. Both therapies improved skin barrier function
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                            2024Acta Dermato-Venereologica
                            Real-world Experience of Abrocitinib Treatment in Patients with Atopic Dermatitis and Hand Eczema: Up to 28-week Results from the BioDay Registry. Limited daily practice data on the effect of abrocitinib in patients with atopic dermatitis are available. The aim of this multicentre prospective study is to evaluate the effectiveness and safety of abrocitinib in patients with atopic dermatitis treated in daily practice. In a subgroup, the effectiveness of abrocitinib on hand eczema was evaluated. A total of 103 patients from the BioDay registry were included in the study: week 4 (n = 95), week 16 (n = 61) and week 28 (n = 39). At week 28, the Eczema Area and Severity Index (EASI)-50/75/90 was achieved by 81.8%, 57.6%, and 18.2%, respectively, and the weekly average pruritus numerical rating
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                            Oral abrocitinib in the treatment of granuloma annulare: a case report. To evaluate the therapeutic efficacy and safety of JAK inhibitor abrocitinib in patients with localized granuloma annulare (GA) and to review the available cases documented in English. We presented a patient who had a persistent, localized granuloma anulare (GA) for one year and did not respond to traditional therapies . This patient was treated with oral abrocitinib at a dosage of 150 mg daily. After 6 weeks of treatment with abrocitinib, the patient exhibited notable symptom improvement with no new lesions. No adverse events or recurrences were reported during the 5-month follow-up period. Abrocitinib may be a promising and safe treatment option for patients with localized GA who do not respond to traditional therapies.
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                            2024Dermatology and therapy
                            Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Early prediction of abrocitinib efficacy in atopic dermatitis (AD) could help identify candidates for an early dose increase. A predictive model determined week 12 efficacy based on week 4 responses in patients receiving abrocitinib 100 mg/day and assessed the effect of an abrocitinib dose increase on platelet counts. Analysis included the phase 3 trials JADE MONO-1 (NCT03349060), MONO-2 (NCT03575871), COMPARE (NCT03720470), and TEEN (NCT03796676). For platelet counts and simulations, a phase 2 psoriasis trial (NCT02201524) and phase 2b (NCT02780167) and phase 3 (MONO-1, MONO-2, and REGIMEN (NCT03627767)) abrocitinib trials
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                            Optimizing maintenance therapy in responders to abrocitinib induction: A post hoc analysis of JADE REGIMEN. Treatment optimization may require dosing flexibility. The Phase 3 JADE REGIMEN trial (NCT03627767) evaluated maintenance of abrocitinib 200 mg-induced response in patients with moderate-to-severe atopic dermatitis (AD) randomly assigned to subsequent maintenance with continuous-dose abrocitinib (200 mg), reduced-dose abrocitinib (100 mg) or placebo. Maintenance with continuous-dose abrocitinib was associated with a stronger prevention of disease flares, but also with a higher occurrence of adverse events, compared with the reduced dose. This post hoc analysis of JADE REGIMEN aimed to identify predictors of not flaring during the maintenance period and to generate tools that can be used