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评估标准治疗方案在管理未能充分控制的中重度特应性皮炎的成年日本患者中的疗效:ADDRESS-J 疾病登记研究的两年数据。

Evaluation of standard treatments for managing adult Japanese patients with inadequately controlled moderate-to-severe atopic dermatitis: Two-year data from the ADDRESS-J disease registry.

机构信息

Department of Dermatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan.

Department of Dermatology, Nippon Medical School, Tokyo, Japan.

出版信息

J Dermatol. 2022 Sep;49(9):903-911. doi: 10.1111/1346-8138.16485. Epub 2022 Jun 17.

DOI:10.1111/1346-8138.16485
PMID:35715964
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9543354/
Abstract

Atopic dermatitis (AD), a chronic relapsing inflammatory skin disease with a high disease burden, is one of the most common dermatological conditions in Japan. Herein, we report the disease profiles and current AD treatment during 2-year management of Japanese adults with moderate-to-severe AD. ADDRESS-J was a prospective, longitudinal, observational study that evaluated real-world effectiveness and safety of current AD treatments of adult patients with moderate-to-severe AD (Investigator's Global Assessment score 3 or 4) in Japan. The maximum follow-up period was 2 years. Among 300 patients enrolled, 288 had ≥1 post-baseline evaluation and were analyzed (mean age, 35.5 years; 60.1% male). Almost all patients (99.7%) received topical therapy; the most commonly used therapy was topical corticosteroids of the second-highest potency (86.5%) (e.g., 0.1% mometasone furoate) followed by medium-potency topical corticosteroids (50.3%) (e.g., 0.05% clobetasol butyrate). At month 12 of the study, 10.4% of patients had Investigator's Global Assessment 0/1, similarly at month 24 (10.8%). A total of 132 patients (45.8%) had ≥1 AD flare-up during the observation period, with the majority of first flares occurring within the first year of the study. Various physician- and patient-reported outcomes improved considerably during the first 3 months of the study, with only minor changes after this time. In this cohort, 16.7% of patients had skin infections requiring treatment; 7.3% had adverse events (AE) potentially related to treatment; 1.7% had serious AE; and 1.0% had treatment discontinuations due to AE. Limitations include missing data at later timepoints and the inclusion criteria limiting generalizability. In summary, this analysis of the ADDRESS-J study showed that some patients with moderate or severe AD respond to conventional therapies, while others do not. For those with inadequately controlled moderate-to-severe AD, the newly emerged systemic agents, such as biologics, may provide a potential strategy for long-term disease management.

摘要

特应性皮炎(AD)是一种慢性复发性炎症性皮肤病,疾病负担高,是日本最常见的皮肤病之一。在此,我们报告了在 2 年的时间里,日本中重度 AD 成年患者的疾病特征和当前 AD 治疗情况。ADDRESS-J 是一项前瞻性、纵向、观察性研究,评估了日本中重度 AD(研究者整体评估评分 3 或 4)成年患者当前 AD 治疗的真实世界疗效和安全性。最大随访时间为 2 年。在入组的 300 例患者中,有 288 例(平均年龄 35.5 岁;60.1%为男性)至少进行了 1 次基线后评估并进行了分析。几乎所有患者(99.7%)均接受了局部治疗;最常用的治疗方法是使用第二强效的局部皮质类固醇(86.5%)(如 0.1%糠酸莫米松),其次是中效局部皮质类固醇(50.3%)(如 0.05%丙酸氯倍他索)。在研究的第 12 个月,有 10.4%的患者达到研究者整体评估 0/1,在第 24 个月时同样为 10.8%。在观察期间,共有 132 例患者(45.8%)发生了 1 次或多次 AD 发作,大多数首次发作发生在研究的前 1 年内。在研究的前 3 个月内,各种医生和患者报告的结局有了显著改善,此后变化很小。在该队列中,有 16.7%的患者发生了需要治疗的皮肤感染;有 7.3%的患者出现了可能与治疗相关的不良事件(AE);有 1.7%的患者发生了严重 AE;有 1.0%的患者因 AE 而停止治疗。局限性包括后期时间点的数据缺失和纳入标准限制了普遍性。总之,对 ADDRESS-J 研究的这项分析表明,一些中重度 AD 患者对常规治疗有反应,而另一些患者则没有。对于那些中重度 AD 控制不佳的患者,新出现的全身性药物,如生物制剂,可能为长期疾病管理提供一种潜在策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/10f9/9543354/53beec299f4a/JDE-49-903-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/10f9/9543354/bdd4948875fd/JDE-49-903-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/10f9/9543354/4989736f2482/JDE-49-903-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/10f9/9543354/53beec299f4a/JDE-49-903-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/10f9/9543354/bdd4948875fd/JDE-49-903-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/10f9/9543354/4989736f2482/JDE-49-903-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/10f9/9543354/53beec299f4a/JDE-49-903-g002.jpg

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