Alexander Tobias, Sewerin Philipp, Strangfeld Anja, Schulte Marcus, Borchert Julia, Garcia Tarcyane Barata, Schrom Eva
Charité, Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin und Humboldt-Universität zu Berlin, Berlin, Germany.
Department and Hiller Research Unit for Rheumatology, UKD, Heinrich-Heine University, Düsseldorf, Germany.
Rheumatol Ther. 2025 Apr;12(2):237-254. doi: 10.1007/s40744-024-00735-5. Epub 2025 Jan 8.
This study evaluated the prevalence and incidence of systemic lupus erythematosus (SLE) in Germany and explored real-world data on sequence of therapy (SOT; sequence of drugs as prescribed in clinical practice).
This retrospective, observational, longitudinal cohort study using German claims data from the WIG2 GmbH Scientific Institute for Health Economics and Health System Research database (January 2011-December 2019), extrapolated to the statutory health insurance (SHI)-insured population, evaluated prevalence and incidence in an epidemiological analysis group and SLE treatment patterns in an incident cohort (subgroup ≥ 18 years of age with incident disease and ≥ 24-month follow-up post index date). Analyses were descriptive.
Based on the epidemiological analysis (N = 3017), annual SLE prevalence per 100,000 gradually increased from 40.47 in 2012 to 59.87 in 2019 in the SHI population. In contrast, annual SLE incidence was relatively stable, ranging from 8.83 in 2012 to 8.86 in 2019. In the incident cohort (n = 941), based on SOT analysis (n = 681), treatment gaps of > 60 days were common: 67.1%, 51.2% and 54.9% in SOT1, SOT2 and SOT3, respectively. Corticosteroids were the most frequent monotherapy in SOT1 (31.0% vs 0% in SOT2/SOT3); 30.0-70.0% of patients received a corticosteroid combination therapy across SOTs. Over 50% of patients in each SOT received an antimalarial therapy (combination or monotherapies). The use of biologic disease-modifying drugs was low, ranging from 0.4% in SOT1 to 9.7% in SOT3.
Our data demonstrate an increased prevalence of SLE with stable incidence in Germany, suggesting improved survival of affected patients. Nevertheless, suboptimal treatment patterns, including limited use of biologics, reflect a high unmet need for optimised and personalised therapies in patients with SLE.
本研究评估了德国系统性红斑狼疮（SLE）的患病率和发病率，并探讨了治疗顺序（SOT；临床实践中规定的药物使用顺序）的真实世界数据。
这项回顾性、观察性、纵向队列研究使用了来自WIG2 GmbH健康经济与卫生系统科学研究所数据库（2011年1月至2019年12月）的德国索赔数据，并外推至法定医疗保险（SHI）参保人群，在一个流行病学分析组中评估患病率和发病率，在一个发病队列（年龄≥18岁且发病后随访≥24个月的亚组）中评估SLE治疗模式。分析为描述性分析。
基于流行病学分析（N = 3017），SHI人群中每10万人的SLE年患病率从2012年的40.47逐渐增加到2019年的59.87。相比之下，SLE年发病率相对稳定，范围从2012年的8.83到2019年的8.86。在发病队列（n = 941）中，基于SOT分析（n = 681），超过60天的治疗中断很常见：SOT1、SOT2和SOT3中分别为67.1%、51.2%和54.9%。皮质类固醇是SOT1中最常用的单一疗法（SOT2/SOT3中为0%）；30.0% - 70.0%的患者在各个SOT中接受了皮质类固醇联合疗法。每个SOT中超过50%的患者接受了抗疟治疗（联合或单一疗法）。生物性疾病改善药物的使用比例较低，范围从SOT1中的0.4%到SOT3中的9.7%。
我们的数据表明德国SLE患病率上升而发病率稳定，这表明受影响患者的生存率有所提高。然而，包括生物制剂使用有限在内的次优治疗模式反映出SLE患者对优化和个性化治疗的高度未满足需求。
