Seo Hyungil, Ye Byong Duk, Song Eun Mi, Lee Sun-Ho, Chang Kiju, Lee Ho-Su, Hwang Sung Wook, Park Sang Hyoung, Yang Dong-Hoon, Kim Kyung-Jo, Byeon Jeong-Sik, Myung Seung-Jae, Yang Suk-Kyun
Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea.
Inflammatory Bowel Disease Center, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Dig Dis Sci. 2017 Oct;62(10):2882-2893. doi: 10.1007/s10620-017-4715-7. Epub 2017 Aug 18.
Large-scale studies regarding the long-term outcomes of adalimumab (ADA) treatment in Asian patients with Crohn's disease (CD) are still scarce.
We retrospectively analyzed the long-term outcomes of ADA treatment in Korean CD patients who commenced on scheduled ADA treatment at Asan Medical Center between November 2008 and July 2016. Clinical response was defined as maintaining ADA treatment without dose intensification (DI) and/or major abdominal surgery (MAS).
Of the 254 patients who received at least two doses of ADA at 2-week intervals as induction therapy, 250 patients (98.4%) showed an initial favorable response by week 4. Among responders, 243 patients were followed up for longer than 4 weeks and were included for further analysis. The median duration of ADA maintenance therapy was 19.4 months. At the last follow-up, 45 patients (18.5%) required DI after a median of 16.8 months and 31 (12.8%) required MAS after a median of 8.9 months. Finally, 161 patients (66.3%) were still receiving ADA without DI and/or MAS. The cumulative probability of maintaining ADA without DI and/or MAS was 81.1% at 1 year, and 36.5% at 5 years. Secondary loss of response to previous infliximab (P = 0.001) and elevated baseline C-reactive protein at starting ADA treatment (P = 0.008) were identified as independent predictors of a poor response to ADA treatment using multivariate regression analysis.
The long-term outcome of ADA treatment in a real-life cohort of Korean patients with CD appears to be comparable to that reported in previously published Western studies.
关于阿达木单抗（ADA）治疗亚洲克罗恩病（CD）患者长期疗效的大规模研究仍然较少。
我们回顾性分析了2008年11月至2016年7月在峨山医学中心开始接受ADA常规治疗的韩国CD患者的长期疗效。临床缓解定义为持续接受ADA治疗且无需增加剂量（DI）和/或进行大腹部手术（MAS）。
在254例接受至少两剂ADA诱导治疗（每2周一次）的患者中，250例（98.4%）在第4周时显示出初始良好反应。在反应者中，243例患者接受了超过4周的随访并纳入进一步分析。ADA维持治疗的中位持续时间为19.4个月。在最后一次随访时，45例患者（18.5%）在中位16.8个月后需要增加剂量，31例患者（12.8%）在中位8.9个月后需要进行大腹部手术。最后，161例患者（66.3%）仍在接受ADA治疗且无需增加剂量和/或进行大腹部手术。在1年时，无需增加剂量和/或进行大腹部手术而持续接受ADA治疗的累积概率为81.1%，在5年时为36.5%。多因素回归分析显示，既往对英夫利昔单抗继发反应丧失（P = 0.001）以及开始ADA治疗时基线C反应蛋白升高（P = 0.008）是ADA治疗反应不佳的独立预测因素。
在韩国CD患者的真实队列中，ADA治疗的长期疗效似乎与先前发表的西方研究报告的结果相当。
