Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
Department of Epidemiology Research, Statens Serum Institute, Copenhagen, Denmark.
Aliment Pharmacol Ther. 2018 Mar;47(5):596-604. doi: 10.1111/apt.14466. Epub 2017 Dec 14.
There are conflicting data on comparative effectiveness of adalimumab and infliximab in patients with Crohn's disease (CD).
To compare the effectiveness and safety of adalimumab and infliximab in biologic-naïve patients with CD, in a nationwide register-based propensity score-matched cohort study in Denmark.
A total of 2908 Danish adults with CD had been treated with adalimumab or infliximab as their first biologic agent between 2005-2014. By Cox regression, we compared rates of all-cause hospitalisation, CD-related hospitalisation, major abdominal surgery and serious infections after variable 2:1 propensity score matching, accounting for baseline disease characteristics, healthcare utilisation and use of CD-related medications.
After propensity-score matching, we included 315 adalimumab- (34.9 ± 12.9 years, 41.9% males) and 512 infliximab-treated (33.6 ± 12.6 years, 40.8% males) patients, with median disease duration 4.0 years; 36.9% had prior abdominal surgery. Over a median follow-up 2.3 years after starting biological therapy, there were no significant differences in rate of CD-related hospitalisation (hazard ratio [HR], 0.81 [95% CI, 0.55-1.20]) or major abdominal surgery (HR, 1.24 [0.66-2.33]) between adalimumab- and infliximab-treated patients, though rate of all-cause hospitalisation was lower in adalimumab-treated patients (HR, 0.74 [0.56-0.97]). There was no significant difference in incidence of serious infections requiring hospitalisation (HR, 1.06 [0.26-4.21]). These results were stable in patients treated with biological monotherapy (all-cause hospitalisation: HR, 0.75 [0.53-1.05]; CD-related hospitalisation: HR, 0.82 [0.51-1.32], abdominal surgery: HR, 1.47 [0.63-3.47]) or in combination with immunomodulators (all-cause hospitalisation: HR, 0.70 [0.44-1.11]; CD-related hospitalisation: HR, 0.80 [0.42-1.52], abdominal surgery: HR, 1.02 [0.39-2.64]).
In this population-based, propensity score matched, real-life cohort study using administrative claims, there was no significant difference in effectiveness and safety of adalimumab and infliximab in biologic-naïve patients with CD.
在克罗恩病（CD）患者中，阿达木单抗和英夫利昔单抗的比较疗效存在相互矛盾的数据。
在丹麦的全国基于登记的倾向评分匹配队列研究中，比较阿达木单抗和英夫利昔单抗在生物初治 CD 患者中的疗效和安全性。
2005-2014 年间，2908 名丹麦成年人首次接受阿达木单抗或英夫利昔单抗治疗。通过 Cox 回归，我们比较了全因住院、CD 相关住院、主要腹部手术和严重感染的发生率，采用了变量 2:1 的倾向评分匹配，考虑了基线疾病特征、医疗保健利用情况和 CD 相关药物的使用情况。
在进行倾向评分匹配后，我们纳入了 315 名接受阿达木单抗（34.9±12.9 岁，41.9%为男性）和 512 名接受英夫利昔单抗治疗的患者（33.6±12.6 岁，40.8%为男性），中位疾病持续时间为 4.0 年；36.9%有过腹部手术史。在开始生物治疗后的中位随访 2.3 年后，阿达木单抗和英夫利昔单抗治疗组的 CD 相关住院率（风险比 [HR]，0.81 [95%CI，0.55-1.20]）或主要腹部手术率（HR，1.24 [0.66-2.33]）没有显著差异，尽管阿达木单抗治疗组的全因住院率较低（HR，0.74 [0.56-0.97]）。严重感染需要住院治疗的发生率无显著差异（HR，1.06 [0.26-4.21]）。在接受生物单药治疗（全因住院：HR，0.75 [0.53-1.05]；CD 相关住院：HR，0.82 [0.51-1.32]，腹部手术：HR，1.47 [0.63-3.47]）或联合免疫调节剂治疗的患者中（全因住院：HR，0.70 [0.44-1.11]；CD 相关住院：HR，0.80 [0.42-1.52]，腹部手术：HR，1.02 [0.39-2.64]），这些结果是稳定的。
在这项基于人群的、采用倾向评分匹配的真实世界队列研究中，使用行政索赔数据，生物初治 CD 患者中阿达木单抗和英夫利昔单抗的疗效和安全性无显著差异。
