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Abstract：
BACKGROUND: This is a secondary database study using the Brazilian public healthcare system database.
OBJECTIVE: To describe intestinal complications (ICs) of patients in the Brazilian public healthcare system with Crohn\'s disease (CD) who initiated and either only received conventional therapy (CVT) or also initiated anti-tumor necrosis factor (anti-TNF) therapy between 2011 and 2020.
METHODS: This study included patients with CD [international classification of diseases - 10th revision (ICD-10): K50.0, K50.1, or K50.8] (age: ≥ 18 years) with at least one claim of CVT (sulfasalazine, azathioprine, mesalazine, or methotrexate). IC was defined as a CD-related hospitalization, pre-defined procedure codes (from rectum or intestinal surgery groups), and/or associated disease (pre-defined ICD-10 codes), and overall (one or more type of ICs).
RESULTS: In the 16809 patients with CD that met the inclusion criteria, the mean follow-up duration was 4.44 (2.37) years. In total, 14697 claims of ICs were found from 4633 patients. Over the 1- and 5-year of follow-up, 8.3% and 8.2% of the patients with CD, respectively, presented at least one IC, of which fistula (31%) and fistulotomy (48%) were the most commonly reported. The overall incidence rate (95%CI) of ICs was 6.8 (6.5-7.04) per 100 patient years for patients using only-CVT, and 9.2 (8.8-9.6) for patients with evidence of anti-TNF therapy.
CONCLUSIONS: The outcomes highlighted an important and constant rate of ICs over time in all the CD populations assessed, especially in patients exposed to anti-TNF therapy. This outcome revealed insights into the real-world treatment and complications relevant to patients with CD and highlights that this disease remains a concern that may require additional treatment strategies in the Brazilian public healthcare system.
OBJECTIVE: To describe intestinal complications (ICs) of patients in the Brazilian public healthcare system with Crohn\'s disease (CD) who initiated and either only received conventional therapy (CVT) or also initiated anti-tumor necrosis factor (anti-TNF) therapy between 2011 and 2020.
METHODS: This study included patients with CD [international classification of diseases - 10th revision (ICD-10): K50.0, K50.1, or K50.8] (age: ≥ 18 years) with at least one claim of CVT (sulfasalazine, azathioprine, mesalazine, or methotrexate). IC was defined as a CD-related hospitalization, pre-defined procedure codes (from rectum or intestinal surgery groups), and/or associated disease (pre-defined ICD-10 codes), and overall (one or more type of ICs).
RESULTS: In the 16809 patients with CD that met the inclusion criteria, the mean follow-up duration was 4.44 (2.37) years. In total, 14697 claims of ICs were found from 4633 patients. Over the 1- and 5-year of follow-up, 8.3% and 8.2% of the patients with CD, respectively, presented at least one IC, of which fistula (31%) and fistulotomy (48%) were the most commonly reported. The overall incidence rate (95%CI) of ICs was 6.8 (6.5-7.04) per 100 patient years for patients using only-CVT, and 9.2 (8.8-9.6) for patients with evidence of anti-TNF therapy.
CONCLUSIONS: The outcomes highlighted an important and constant rate of ICs over time in all the CD populations assessed, especially in patients exposed to anti-TNF therapy. This outcome revealed insights into the real-world treatment and complications relevant to patients with CD and highlights that this disease remains a concern that may require additional treatment strategies in the Brazilian public healthcare system.
摘要：
背景：这是使用巴西公共医疗系统数据库的二级数据库研究。
目的：描述巴西公共医疗系统克罗恩病（CD）患者的肠道并发症（IC），这些患者在2011年至2020年期间开始并仅接受常规治疗（CVT）或开始抗肿瘤坏死因子（anti-TNF）治疗。
方法：这项研究包括患有CD[国际疾病分类-第10次修订（ICD-10）：K50.0，K50.1或K50.8]（年龄：≥18岁）的患者，至少有一项CVT（柳氮磺吡啶，硫唑嘌呤，美沙拉嗪,或甲氨蝶呤）。IC被定义为与CD相关的住院，预定义的程序代码（来自直肠或肠道手术组），和/或相关疾病（预定义的ICD-10代码），和整体（一种或多种类型的IC）。
结果：在符合纳入标准的16809例CD患者中，平均随访时间为4.44(2.37)年.总的来说,从4633名患者中发现了14697项IC索赔。在1年和5年的随访中，8.3％和8.2％的CD患者，分别,至少有一个IC，其中瘘管（31％）和瘘管切开术（48％）是最常见的报道。对于仅使用CVT的患者，IC的总发病率（95CI）为6.8（6.5-7.04）/100患者年，对于有抗TNF治疗证据的患者为9.2（8.8-9.6）。
结论：结果强调了在所有评估的CD人群中，随着时间的推移，IC的重要且恒定的比率，特别是在接受抗TNF治疗的患者中。这一结果揭示了与CD患者相关的现实世界治疗和并发症的见解，并强调这种疾病仍然是一个问题，可能需要在巴西公共医疗系统中采取额外的治疗策略。
目的：描述巴西公共医疗系统克罗恩病（CD）患者的肠道并发症（IC），这些患者在2011年至2020年期间开始并仅接受常规治疗（CVT）或开始抗肿瘤坏死因子（anti-TNF）治疗。
方法：这项研究包括患有CD[国际疾病分类-第10次修订（ICD-10）：K50.0，K50.1或K50.8]（年龄：≥18岁）的患者，至少有一项CVT（柳氮磺吡啶，硫唑嘌呤，美沙拉嗪,或甲氨蝶呤）。IC被定义为与CD相关的住院，预定义的程序代码（来自直肠或肠道手术组），和/或相关疾病（预定义的ICD-10代码），和整体（一种或多种类型的IC）。
结果：在符合纳入标准的16809例CD患者中，平均随访时间为4.44(2.37)年.总的来说,从4633名患者中发现了14697项IC索赔。在1年和5年的随访中，8.3％和8.2％的CD患者，分别,至少有一个IC，其中瘘管（31％）和瘘管切开术（48％）是最常见的报道。对于仅使用CVT的患者，IC的总发病率（95CI）为6.8（6.5-7.04）/100患者年，对于有抗TNF治疗证据的患者为9.2（8.8-9.6）。
结论：结果强调了在所有评估的CD人群中，随着时间的推移，IC的重要且恒定的比率，特别是在接受抗TNF治疗的患者中。这一结果揭示了与CD患者相关的现实世界治疗和并发症的见解，并强调这种疾病仍然是一个问题，可能需要在巴西公共医疗系统中采取额外的治疗策略。
