Song Joo Hye, Hong Sung Noh, Lee Jung Eun, Kim Kyunga, Kim Tae Jun, Kim Eun Ran, Chang Dong Kyung, Kim Young-Ho
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul , Korea.
Research Institute for Future Medicine, Samsung Medical Center, Biostatistics and Clinical Epidemiology Center , Seoul , Korea.
Scand J Gastroenterol. 2019 Jul;54(7):876-885. doi: 10.1080/00365521.2019.1638962. Epub 2019 Jul 15.
The objective of this study is to identify clinical predictors of primary non-response (PNR) and secondary loss of response (LOR), in Crohn's disease (CD) patients treated with anti-tumor necrosis factor α (anti-TNF) agents. This retrospective, longitudinal, and observational cohort study included 283 patients with CD who received anti-TNF treatments from November 2006 to July 2017 at Samsung Medical Center, Seoul, Korea. A total of 212 patients with CD were eligible and based on clinical responses, divided into three groups: PNR, LOR, and responder groups. PNR occurred in 13 patients (6.1%). C-Reactive protein (CRP) level at initiation of anti-TNF (baseline CRP) was a possible predictor of PNR compared to the non-PNR group (baseline CRP >1 mg/dl, OR = 4.34, 95% CI = 1.06-17.83, .042). During maintenance therapy, incidence of LOR was 12.2% at 1-year, 23.6% at 2-years, 36.3% at 3-years, and 52.1% at 5-years. Combining baseline CRP level and CRP reduction rate [(CRP at 12-14 weeks-baseline CRP)/baseline CRP] was a possible predictor of 1-year LOR compared to the responder group (baseline CRP >1 mg/dl and CRP reduction rate > -70%, OR = 18.86, 95% CI = 3.40-104.55, .001). In the Cox hazard proportional model, a combination of baseline CRP level and CRP reduction rate was possible predictors of long-term LOR during maintenance therapy (baseline CRP >1 mg/dl and CRP reduction rate > -70%, HR = 5.84, 95% CI = 2.75-12.41, .001). Baseline CRP level and CRP reduction rate might be clinical predictors for PNR or LOR to anti-TNF in patients with CD, and could guide proper therapeutic interventions in patients with CD.
本研究的目的是确定接受抗肿瘤坏死因子α(抗TNF)药物治疗的克罗恩病(CD)患者原发性无反应(PNR)和继发性反应丧失(LOR)的临床预测因素。这项回顾性、纵向观察性队列研究纳入了2006年11月至2017年7月在韩国首尔三星医疗中心接受抗TNF治疗的283例CD患者。共有212例CD患者符合条件,并根据临床反应分为三组:PNR组、LOR组和反应者组。13例患者(6.1%)出现PNR。与非PNR组相比,抗TNF治疗开始时的C反应蛋白(CRP)水平(基线CRP)可能是PNR的预测因素(基线CRP>1mg/dl,OR=4.34,95%CI=1.06-17.83,P=0.042)。在维持治疗期间,LOR的发生率在1年时为12.2%,2年时为23.6%,3年时为36.3%,5年时为52.1%。与反应者组相比,将基线CRP水平和CRP降低率[(12-14周时的CRP-基线CRP)/基线CRP]相结合可能是1年LOR的预测因素(基线CRP>1mg/dl且CRP降低率>-70%,OR=18.86,95%CI=3.40-104.55,P=0.001)。在Cox风险比例模型中,基线CRP水平和CRP降低率的组合可能是维持治疗期间长期LOR的预测因素(基线CRP>1mg/dl且CRP降低率>-70%,HR=5.84,95%CI=2.75-12.41,P=0.001)。基线CRP水平和CRP降低率可能是CD患者抗TNF治疗PNR或LOR的临床预测因素,并可指导CD患者进行适当的治疗干预。