目的:透壁愈合(TH)正在成为一个潜在的克罗恩病(CD)治疗目标。早期生物治疗似乎与改善疾病预后有关。但其对TH的影响尚不清楚。我们旨在评估早期生物治疗对TH的影响及其对CD预后的影响。
方法:这项多中心回顾性研究包括开始生物治疗的成人CD患者。在治疗开始后12±6个月,使用磁共振小肠造影(MRE)评估TH,由盲目的放射科专家进行放射学检查。TH被定义为所有MRE参数的完全归一化。生物治疗开始的时间被分析为一个连续变量,使用Youden指数和临床相关性确定最佳截止值。使用倾向评分调整分析的Logistic回归来评估早期生物治疗开始与TH之间的关联。长期结果(肠损伤进展,CD相关手术,CD-耀斑住院治疗,和治疗升级)进行评估。
结果:在154例CD患者中,诊断后12个月内的早期生物治疗开始与显着较高的TH率相关(aOR3.23,95%CI1.36-7.70,p<0.01),在调整以前的生物治疗使用后仍然存在(aOR2.82,95%CI1.13-7.06,p=0.03)。事件发生时间分析表明,TH与肠损伤进展前的时间减少显著相关(aHR0.28,95%CI0.10-0.79,p=0.02)。CD相关手术(aHR0.21,95%CI0.05-0.88,p=0.03)和治疗升级(aHR0.35,95CI0.14-0.88,p=0.02),独立于早期生物治疗。
结论:在诊断后12个月内早期开始生物治疗显著增加了TH率,改善CD患者的长期结局。
OBJECTIVE: Transmural healing (TH) is emerging as a potential Crohn´s Disease (CD) treatment target. Early biological treatment seems to be associated with improved disease outcomes, but its impact on TH remains unclear. We aimed to assess the impact of early biological treatment initiation on TH and its influence on CD prognosis.
METHODS: This multicenter retrospective study included adult CD patients starting biological therapy. TH was assessed using magnetic resonance enterography (MRE) at 12±6 months post-therapy initiation, with radiological examinations reviewed by blinded expert radiologists. TH was defined as complete normalization of all MRE parameters. Timing of biological therapy initiation was analyzed as a continuous variable, with optimal cut-off determined using the Youden index and clinical relevance. Logistic regression with propensity score-adjusted analysis was used to assess the association between early biological therapy initiation and TH. Long-term outcomes (bowel damage progression, CD-related surgery, CD-flare hospitalization, and therapy escalation) were evaluated.
RESULTS: Among 154 CD patients, early biological therapy initiation within 12 months of diagnosis was associated with significantly higher TH rates (aOR 3.23, 95% CI 1.36-7.70, p<0.01), which persisted after adjusting for previous biological therapy use (aOR 2.82, 95% CI 1.13-7.06, p=0.03). Time-to-event analysis demonstrated that TH was significantly associated with reduced time until bowel damage progression (aHR 0.28, 95% CI 0.10-0.79, p=0.02), CD-related surgery (aHR 0.21, 95% CI 0.05-0.88, p=0.03) and therapy escalation (aHR 0.35, 95%CI 0.14-0.88, p=0.02), independently of early biological therapy.
CONCLUSIONS: Early initiation of biological therapy within 12 months of diagnosis significantly increases TH rates, leading to improved long-term outcomes in CD patients.