PDF(Pubmed)
Abstract：
OBJECTIVE: The aim of this study was to investigate the burden of disease among a real-world cohort of patients with prevalent Crohn\'s disease (CD) in Germany.
METHODS: We conducted a retrospective cohort analysis using administrative claims data from the German AOK PLUS health insurance fund. Continuously insured patients with a CD diagnosis between 01 October 2014 and 31 December 2018 were selected and followed for at least 12 months or longer until death or end of data availability on 31 December 2019. Medication use (biologics, immunosuppressants (IMS), steroids, 5-aminosalicylic acid) was assessed sequentially in the follow-up period. Among patients with no IMS or biologics (advanced therapy), we investigated indicators of active disease and corticosteroid use.
RESULTS: Overall, 9284 prevalent CD patients were identified. Within the study period, 14.7% of CD patients were treated with biologics and 11.6% received IMS. Approximately 47% of all prevalent CD patients had mild disease, defined as no advanced therapy and signs of disease activity. Of 6836 (73.6%) patients who did not receive advanced therapy in the follow-up period, 36.3% showed signs of active disease; 40.1% used corticosteroids (including oral budesonide), with 9.9% exhibiting steroid dependency (≥ 1 prescription every 3 months for at least 12 months) in the available follow-up.
CONCLUSIONS: This study suggests that there remains a large burden of disease among patients who do not receive IMS or biologics in the real world in Germany. A revision of treatment algorithms of patients in this setting according to the latest guidelines may improve patient outcomes.
METHODS: We conducted a retrospective cohort analysis using administrative claims data from the German AOK PLUS health insurance fund. Continuously insured patients with a CD diagnosis between 01 October 2014 and 31 December 2018 were selected and followed for at least 12 months or longer until death or end of data availability on 31 December 2019. Medication use (biologics, immunosuppressants (IMS), steroids, 5-aminosalicylic acid) was assessed sequentially in the follow-up period. Among patients with no IMS or biologics (advanced therapy), we investigated indicators of active disease and corticosteroid use.
RESULTS: Overall, 9284 prevalent CD patients were identified. Within the study period, 14.7% of CD patients were treated with biologics and 11.6% received IMS. Approximately 47% of all prevalent CD patients had mild disease, defined as no advanced therapy and signs of disease activity. Of 6836 (73.6%) patients who did not receive advanced therapy in the follow-up period, 36.3% showed signs of active disease; 40.1% used corticosteroids (including oral budesonide), with 9.9% exhibiting steroid dependency (≥ 1 prescription every 3 months for at least 12 months) in the available follow-up.
CONCLUSIONS: This study suggests that there remains a large burden of disease among patients who do not receive IMS or biologics in the real world in Germany. A revision of treatment algorithms of patients in this setting according to the latest guidelines may improve patient outcomes.
摘要：
目的：本研究的目的是调查德国克罗恩病（CD）患者的实际队列中的疾病负担。
方法：我们使用德国AOKPLUS医疗保险基金的行政索赔数据进行了回顾性队列分析。选择在2014年10月1日至2018年12月31日期间诊断为CD的连续参保患者，并随访至少12个月或更长时间，直到死亡或2019年12月31日数据可用性结束。药物使用（生物制剂，免疫抑制剂（IMS），类固醇,5-氨基水杨酸）在随访期间依次评估。在没有IMS或生物制剂（晚期治疗）的患者中，我们调查了活动性疾病和皮质类固醇使用的指标.
结果：总体而言，确定了9284名流行的CD患者。在学习期间,14.7%的CD患者接受生物制剂治疗，11.6%接受IMS治疗。所有流行的CD患者中约有47％患有轻度疾病，定义为没有先进的治疗和疾病活动的迹象。6836例（73.6%）在随访期间未接受晚期治疗的患者中，36.3％的患者出现活动性疾病迹象；40.1％的患者使用皮质类固醇（包括口服布地奈德），在可用的随访中，有9.9％表现出类固醇依赖性（至少12个月，每3个月≥1个处方）。
结论：这项研究表明，在德国的现实世界中，没有接受IMS或生物制剂的患者仍然存在很大的疾病负担。根据最新指南对这种情况下患者的治疗算法进行修订可能会改善患者的预后。
方法：我们使用德国AOKPLUS医疗保险基金的行政索赔数据进行了回顾性队列分析。选择在2014年10月1日至2018年12月31日期间诊断为CD的连续参保患者，并随访至少12个月或更长时间，直到死亡或2019年12月31日数据可用性结束。药物使用（生物制剂，免疫抑制剂（IMS），类固醇,5-氨基水杨酸）在随访期间依次评估。在没有IMS或生物制剂（晚期治疗）的患者中，我们调查了活动性疾病和皮质类固醇使用的指标.
结果：总体而言，确定了9284名流行的CD患者。在学习期间,14.7%的CD患者接受生物制剂治疗，11.6%接受IMS治疗。所有流行的CD患者中约有47％患有轻度疾病，定义为没有先进的治疗和疾病活动的迹象。6836例（73.6%）在随访期间未接受晚期治疗的患者中，36.3％的患者出现活动性疾病迹象；40.1％的患者使用皮质类固醇（包括口服布地奈德），在可用的随访中，有9.9％表现出类固醇依赖性（至少12个月，每3个月≥1个处方）。
结论：这项研究表明，在德国的现实世界中，没有接受IMS或生物制剂的患者仍然存在很大的疾病负担。根据最新指南对这种情况下患者的治疗算法进行修订可能会改善患者的预后。
