Evaluating Inadequate Therapy Response in Ulcerative Colitis Adult Patients: A Retrospective Analysis of German Health Claims Data on Advanced Therapy Initiation

Axel Dignass, Irina Blumenstein, Carolina Schwedhelm, Katrin Strassen, Leonie Berger, Sophie Marquardt, Anna Seiffert, Nataliia Kulchytska, Ivonne Haensel, Alexa Benson, Agnes Kisser
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Abstract

Background: The treatment landscape for active ulcerative colitis (UC) is rapidly evolving and current real-world evidence on response to advanced therapy is limited. This study aimed to determine indicators of inadequate therapeutic response among patients with UC in Germany initiating advanced therapy. Methods: This retrospective analysis used German claims data (2015-2022) from adult patients (≥18 years). Prevalence and incidence of UC (ICD-10-GM: K51.X) were estimated. Inadequate response to therapy was evaluated in patients initiating advanced therapy based on eight predefined indicators observed for 12 months following index treatment prescription. Results: Mean UC patient age in 2016-2022 ranged from 49.6 to 51.5 years, 47.6%-48.3% were female. Administrative prevalence ranged from 0.45% in 2016 to 0.53% in 2022. Number of patients initiating advanced treatment ranged from 157 to 347 across the study years (3.2%-4.9% of overall treated study population). On average from 2016-2021, 78.8% had inadequate response in the 12 months following index treatment. Common indicators included prolonged use of corticosteroids (46.2%) and augmentation with conventional therapies (43.9%). Conclusions: Adult UC patients showed a high prevalence of inadequate response to advanced therapies. Our findings reveal a need for improved UC advanced therapy options, providing insight into inadequate response patterns. This may help identify patients who could benefit from a change in therapy to improve long-term outcomes.
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评估溃疡性结肠炎成人患者的治疗反应不足:对德国健康索赔数据中有关晚期治疗启动情况的回顾性分析
背景:活动性溃疡性结肠炎(UC)的治疗格局正在迅速演变,而目前现实世界中关于晚期治疗反应的证据非常有限。本研究旨在确定德国开始接受晚期治疗的 UC 患者治疗反应不充分的指标:这项回顾性分析使用了德国成年患者(≥18 岁)的索赔数据(2015-2022 年)。估算了 UC(ICD-10-GM:K51.X)的患病率和发病率。根据指数治疗处方后12个月内观察到的8项预定指标,对开始接受高级治疗的患者的治疗反应不充分情况进行了评估:2016-2022年UC患者的平均年龄在49.6-51.5岁之间,47.6%-48.3%为女性。行政患病率从 2016 年的 0.45% 到 2022 年的 0.53%。在各研究年度中,开始晚期治疗的患者人数从 157 人到 347 人不等(占总体治疗研究人群的 3.2%-4.9% )。从 2016 年到 2021 年,平均 78.8% 的患者在指标治疗后的 12 个月内反应不充分。常见指标包括长期使用皮质类固醇激素(46.2%)和使用常规疗法(43.9%):结论:成年 UC 患者对先进疗法反应不足的发生率很高。我们的研究结果表明,有必要改进 UC 先进疗法的选择,以便深入了解反应不足的模式。这可能有助于确定哪些患者可以从改变疗法中获益,从而改善长期预后。
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