Aparato Digestivo , Hospital Clínico San Carlos , España.
Aparato Digestivo , Hospital Universitario La Paz, España.
Rev Esp Enferm Dig. 2019 Nov;111(11):846-851. doi: 10.17235/reed.2019.6148/2018.
to compare the need for and time to adalimumab dose escalation and de-escalation between patients with Crohn's disease (CD) and ulcerative colitis (UC).
this observational cohort study included patients with luminal CD or patients with UC treated with adalimumab. Adalimumab dose optimization was decided based on the Harvey-Bradshaw index (CD) or the partial Mayo score (UC). The co-primary endpoints were the differences in the rate of dose escalation and the cumulative probability of escalation-free survival between cohorts. We also evaluated the rates of de-escalation and predictors of adalimumab dose escalation and de-escalation.
twenty-four of 43 CD patients (56%) and 28 of 43 UC patients (65%) required adalimumab dose escalation. UC patients had a higher adjusted rate of dose escalation (hazard ratio [HR] 2.33, 95% confidence interval [CI] 1.19-4.56; p = 0.013) than CD patients. The median time to dose escalation was significantly shorter for UC than CD patients (3.2 months, interquartile range [IQR]: 2.0-10.3 vs 12.2 months, IQR: 6.1-35.7; p = 0.001). Survival curves showed that UC patients had an increased probability of dose escalation (p < 0.001). Prior anti-TNF therapy was associated with dose escalation (HR 2.13, 95% CI 1.05-4.34; p = 0.037). Adalimumab dose de-escalation was attempted in 32% of UC patients and 50% of CD patients. Survival curves showed that CD patients had an increased probability of dose de-escalation (p = 0.030).
UC patients more frequently required adalimumab dose escalation than CD patients. UC patients required optimization earlier than CD patients. More CD patients than UC patients can be dose de-escalated later on during treatment.
比较克罗恩病(CD)和溃疡性结肠炎(UC)患者阿达木单抗剂量升级和降级的需求和时间。
本观察性队列研究纳入了接受阿达木单抗治疗的腔肠 CD 患者或 UC 患者。阿达木单抗剂量优化基于 Harvey-Bradshaw 指数(CD)或部分 Mayo 评分(UC)决定。主要共同终点是两个队列之间剂量升级率和无升级生存累积概率的差异。我们还评估了降级率和阿达木单抗剂量升级和降级的预测因素。
43 例 CD 患者中有 24 例(56%)和 43 例 UC 患者中有 28 例(65%)需要阿达木单抗剂量升级。UC 患者的剂量升级调整率更高(风险比[HR]2.33,95%置信区间[CI]1.19-4.56;p=0.013)。UC 患者达到剂量升级的中位时间明显短于 CD 患者(3.2 个月,四分位距[IQR]:2.0-10.3 与 12.2 个月,IQR:6.1-35.7;p=0.001)。生存曲线表明 UC 患者剂量升级的可能性增加(p<0.001)。既往抗 TNF 治疗与剂量升级相关(HR 2.13,95%CI 1.05-4.34;p=0.037)。32%的 UC 患者和 50%的 CD 患者尝试了阿达木单抗剂量下调。生存曲线表明 CD 患者剂量下调的可能性增加(p=0.030)。
UC 患者比 CD 患者更频繁地需要阿达木单抗剂量升级。UC 患者比 CD 患者更早需要优化治疗。在治疗过程中,更多的 CD 患者可以在后期下调剂量。