BACKGROUND AND AIMS While a minority of inflammatory bowel disease (IBD) patients receives biologics in Germany, little is known about therapeutic needs of patients receiving non-biologic therapies. This study aimed to identify indicators of active disease/steroid dependency in patients with moderate to severe Crohn's disease (CD) and ulcerative colitis (UC) treated with conventional therapies and to describe health care resource use (HCRU)/cost. METHODS CD/UC patients treated with immunosuppressants (IS) and/or systemic or locally acting oral corticosteroids (CS) were identified in German claims data (2013-2017) and followed for 12 months post-therapy start. Indicators of active disease/steroid dependency during follow-up period were (i) ≥ 2 prescriptions of CS (sensitivity ≥ 4) or (ii) ≥ 1 IBD-related surgery or (iii) > 7 days IBD-related hospitalization(s). RESULTS Of 9871 included IBD patients (5170 CD, 4701 UC), 25.7%/19.9% (CD/UC) received ≥ 2 prescriptions of CS (sensitivity, 17.4%/15.7%) (i), 3.2% experienced IBD-related surgeries (ii), and 2.5% > 7 days of hospitalizations (iii). Altogether, 44.4% had indicators of active disease/steroid dependency (sensitivity, 23.9%). Among patients with active disease/steroid dependency, 78.0% received CS monotherapy at baseline. Of these, 89.6% received a CS monotherapy in the follow-up period, too. Proportionally, fewer patients with CS monotherapy (57.4%) than IS therapy (91.0%) visited a specialist. HCRU/cost per patient year was significantly higher in patients with than without active disease/steroid dependency. CONCLUSIONS A substantial percentage of biologic-naïve IBD patients suffers from active disease/steroid dependency. The majority receives a monotherapy with systemic CS. Referral to gastroenterologists for treatment optimization is recommended, also because active disease/steroid dependency is associated with increased HCRU/cost.

中文翻译：

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在德国现实世界中未接受生物制剂治疗的炎症性肠病患者的活动性疾病和类固醇依赖性指标。

背景和目标 虽然德国有少数炎症性肠病 (IBD) 患者接受生物制剂治疗，但人们对接受非生物制剂治疗的患者的治疗需求知之甚少。本研究旨在确定接受常规疗法治疗的中度至重度克罗恩病（CD）和溃疡性结肠炎（UC）患者的活动性疾病/类固醇依赖性指标，并描述医疗保健资源使用（HCRU）/成本。方法 德国索赔数据（2013-2017 年）中确定了接受免疫抑制剂 (IS) 和/或全身或局部作用的口服皮质类固醇 (CS) 治疗的 CD/UC 患者，并在治疗开始后随访 12 个月。随访期间活动性疾病/类固醇依赖性指标为 (i) ≥ 2 次 CS 处方（敏感性≥ 4）或 (ii) ≥ 1 次 IBD 相关手术或 (iii) > 7 天 IBD 相关住院。结果 在 9871 名 IBD 患者（5170 例 CD，4701 UC）中，25.7%/19.9%（CD/UC）接受了 ≥ 2 种 CS 处方（敏感性，17.4%/15.7%）(i)，3.2% 经历过 IBD 相关手术(ii) 和 2.5% > 7 天的住院治疗 (iii)。总共，44.4% 的人有活动性疾病/类固醇依赖的指标（敏感性，23.9%）。在患有活动性疾病/类固醇依赖的患者中，78.0% 在基线时接受了 CS 单药治疗。其中，89.6% 的患者在随访期间也接受了 CS 单一疗法。按比例来看，接受 CS 单一疗法的患者 (57.4%) 比接受 IS 疗法 (91.0%) 就诊的患者要少。与没有活动性疾病/类固醇依赖的患者相比，患有活动性疾病/类固醇依赖的患者每年的 HCRU/费用显着更高。结论 相当大比例的未使用过生物制剂的 IBD 患者患有活动性疾病/类固醇依赖性。大多数人接受全身 CS 单一疗法。建议转诊胃肠病学家进行治疗优化，也是因为活动性疾病/类固醇依赖性与 HCRU/成本增加相关。