دورية أكاديمية
Efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis with inadequate response, intolerance or contraindication to ciclosporin: results from a randomized, placebo-controlled, phase III clinical trial (BREEZE-AD4).
| العنوان: | Efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis with inadequate response, intolerance or contraindication to ciclosporin: results from a randomized, placebo-controlled, phase III clinical trial (BREEZE-AD4). |
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| المؤلفون: | Bieber, Thomas, Reich, Kristian, Paul, Carle, Tsunemi, Yuichiro, Augustin, Matthias, Lacour, Jean-Philippe, Ghislain, Pierre-Dominique, Dutronc, Yves, Liao, Ran, Yang, Fan E, Brinker, Dennis, DeLozier, Amy M, Meskimen, Eric, Janes, Jonathan M, Eyerich, Kilian, BREEZE-AD4 study group |
| المساهمون: | UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, UCL - (SLuc) Service de dermatologie |
| المصدر: | The British journal of dermatology, Vol. 187, no.3, p. 338-352 (2022) |
| بيانات النشر: | Oxford University Press |
| سنة النشر: | 2022 |
| المجموعة: | DIAL@UCL (Université catholique de Louvain) |
| مصطلحات موضوعية: | Adrenal Cortex Hormones, Azetidines, Contraindications, Cyclosporine, Dermatitis, Atopic, Dermatologic Agents, Double-Blind Method, Headache, Herpes Simplex, Humans, Influenza, Human, Nasopharyngitis, Purines, Pyrazoles, Severity of Illness Index, Sulfonamides, Treatment Outcome |
| الوصف: | BACKGROUND: Baricitinib, an oral selective Janus kinase (JAK)1 and JAK 2 inhibitor, was shown to improve the signs and symptoms of moderate-to-severe atopic dermatitis (AD). OBJECTIVES: To evaluate the efficacy and safety of baricitinib with background topical corticosteroids (TCS) in patients with moderate-to-severe AD and inadequate response, intolerance or contraindication to ciclosporin A (CA). METHODS: In this double-blind, randomized, placebo-controlled, phase III study, patients were randomized 1: 1: 2: 1 to placebo (N = 93), baricitinib 1 mg (N = 93), 2 mg (N = 185) or 4 mg (N = 92) with background TCS. The primary endpoint was the proportion of patients receiving baricitinib 4 mg or 2 mg (+ TCS) vs. placebo + TCS who achieved ≥ 75% improvement from baseline in the Eczema Area and Severity Index (EASI 75) at week 16. RESULTS: Baricitinib 4 mg + TCS was superior to placebo + TCS for EASI 75 (4 mg: 32%, placebo: 17%, P = 0·031) at week 16 and for improvements in itch, skin pain and number of night-time awakenings owing to itch. Improvements were maintained through 52 weeks of treatment. Treatment-emergent adverse events (TEAEs) were more common with baricitinib than placebo (+ TCS); most were mild or moderate. The most frequent TEAEs with baricitinib 4 mg + TCS were nasopharyngitis, herpes simplex, influenza and headache. No deaths or deep vein thromboses were reported. CONCLUSIONS: Baricitinib 4 mg + TCS improved the signs and symptoms of moderate-to-severe AD through 52 weeks of treatment in patients with inadequate response, intolerance or contraindication to CA. The safety profile was consistent with previous studies of baricitinib in moderate-to-severe AD. What is already known about this topic? Ciclosporin A is indicated for the treatment of atopic dermatitis that is refractory to topical therapies. However, its use is limited by safety concerns and it may not provide adequate response for some patients. Baricitinib, an oral selective Janus kinase (JAK)1 and JAK2 inhibitor, has been shown to ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0007-0963 1365-2133 |
| العلاقة: | boreal:278134; http://hdl.handle.net/2078.1/278134Test; info:pmid/35484697; urn:ISSN:0007-0963; urn:EISSN:1365-2133 |
| DOI: | 10.1111/bjd.21630 |
| الإتاحة: | https://doi.org/10.1111/bjd.21630Test http://hdl.handle.net/2078.1/278134Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.9166ED11 |
| قاعدة البيانات: | BASE |
| تدمد: | 00070963 13652133 |
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| DOI: | 10.1111/bjd.21630 |