University of Calgary, Department of Medicine, Calgary, AB, Canada.
IBD Unit, Karolinska Institutet, Stockholm, Sweden.
J Crohns Colitis. 2019 May 27;13(6):725-734. doi: 10.1093/ecco-jcc/jjy223.
Analyses of Crohn's Disease [CD] studies of anti-TNF agents, including adalimumab, have reported higher remission rates among patients with shorter disease duration. To further explore the relationship between disease duration and clinical efficacy, we analysed a larger patient cohort.
Data were pooled from 10 clinical trials in patients with moderately to severely active CD who received treatment with either adalimumab or placebo. Analyses of efficacy using Crohn's Disease Activity Index [CDAI] endpoints [remission, clinical response [CR]-70, CR-100, patient-reported outcome [PRO] remission] or Harvey-Bradshaw Index [HBI] endpoints [remission/response] were conducted for induction and maintenance treatment periods. Logistic regression was used for comparisons between adalimumab and placebo treatment. Cochran-Armitage trend tests were used for comparisons between disease-duration subgroups [<1 year, ≥1-<2 years, 2-≤5 years, and >5 years].
During induction, the proportion of patients achieving CDAI remission was higher in adalimumab- versus placebo-treated patients [p <0.001] and was highest [adalimumab: 45.8%] in the <1 year subgroup compared with longer disease-duration subgroups [≥1-<2 years: 31.0%; 2-≤5 years: 23.1%; >5 years: 23.6%, Cochran-Armitage p = 0.026]. In the majority of maintenance treatment analyses, patients with <1 year disease duration had the highest efficacy responses, with statistically significant differences in remission rates across disease-duration subgroups.
This analysis demonstrates that earlier initiation of adalimumab treatment shortly after diagnosis in patients with moderately to severely active CD leads to improved long-term clinical outcomes.
分析抗 TNF 药物（包括阿达木单抗）治疗克罗恩病（CD）的研究报告称，疾病持续时间较短的患者缓解率更高。为了进一步探讨疾病持续时间与临床疗效的关系，我们分析了更大的患者队列。
数据来自 10 项临床试验，纳入接受阿达木单抗或安慰剂治疗的中重度活动期 CD 患者。使用克罗恩病活动指数（CDAI）终点[缓解、临床反应（CR）-70、CR-100、患者报告结局（PRO）缓解]或 Harvey-Bradshaw 指数（HBI）终点[缓解/反应]分析疗效。采用逻辑回归比较阿达木单抗与安慰剂治疗的疗效。采用 Cochran-Armitage 趋势检验比较疾病持续时间亚组（<1 年、≥1-<2 年、2-≤5 年和>5 年）之间的差异。
在诱导期，阿达木单抗治疗组患者达到 CDAI 缓解的比例高于安慰剂治疗组（p<0.001），与较长疾病持续时间亚组相比，<1 年疾病持续时间亚组的缓解率最高[阿达木单抗：45.8%；≥1-<2 年：31.0%；2-≤5 年：23.1%；>5 年：23.6%，Cochran-Armitage p=0.026]。在大多数维持治疗分析中，疾病持续时间<1 年的患者具有最高的疗效反应，疾病持续时间亚组之间的缓解率存在统计学差异。
本分析表明，在中重度活动期 CD 患者确诊后尽早开始阿达木单抗治疗可改善长期临床结局。
