Zheng Fang-Yuan, Yang Kai-Si, Min Wen-Cheng, Li Xin-Zhu, Xing Yu, Wang Shuai, Zhang Ying-Shi, Zhao Qing-Chun
Teaching Hospital of Shenyang Pharmaceutical University, General Hospital of Northern Theater Command, Shenyang 110016, Liaoning Province, China.
World J Gastrointest Surg. 2024 Feb 27;16(2):571-584. doi: 10.4240/wjgs.v16.i2.571.
The efficacy and safety of anti-tumor necrosis factor-α (TNF-α) monoclonal antibody therapy [adalimumab (ADA) and infliximab (IFX)] with therapeutic drug monitoring (TDM), which has been proposed for inflammatory bowel disease (IBD) patients, are still controversial.
To determine the efficacy and safety of anti-TNF-α monoclonal antibody therapy with proactive TDM in patients with IBD and to determine which subtype of IBD patients is most suitable for proactive TDM interventions.
As of July 2023, we searched for randomized controlled trials (RCTs) and observational studies in PubMed, Embase, and the Cochrane Library to compare anti-TNF-α monoclonal antibody therapy with proactive TDM with therapy with reactive TDM or empiric therapy. Pairwise and network meta-analyses were used to determine the IBD patient subtype that achieved clinical remission and to determine the need for surgery.
This systematic review and meta-analysis yielded 13 studies after exclusion, and the baseline indicators were balanced. We found a significant increase in the number of patients who achieved clinical remission in the ADA [odds ratio (OR) = 1.416, 95% confidence interval (CI): 1.196-1.676] and RCT (OR = 1.393, 95%CI: 1.182-1.641) subgroups and a significant decrease in the number of patients who needed surgery in the proactive reactive (OR = 0.237, 95%CI: 0.101-0.558) and IFX + ADA (OR = 0.137, 95%CI: 0.032-0.588) subgroups, and the overall risk of adverse events was reduced (OR = 0.579, 95%CI: 0.391-0.858) according to the pairwise meta-analysis. Moreover, the network meta-analysis results suggested that patients with IBD treated with ADA (OR = 1.39, 95%CI: 1.19-1.63) were more likely to undergo TDM, especially in comparison with patients with reactive TDM (OR = 1.38, 95%CI: 1.07-1.77).
Proactive TDM is more suitable for IBD patients treated with ADA and has obvious advantages over reactive TDM. We recommend proactive TDM in IBD patients who are treated with ADA.
针对炎症性肠病（IBD）患者提出的抗肿瘤坏死因子-α（TNF-α）单克隆抗体疗法[阿达木单抗（ADA）和英夫利昔单抗（IFX）]联合治疗药物监测（TDM）的疗效和安全性仍存在争议。
确定IBD患者接受抗TNF-α单克隆抗体联合主动TDM治疗的疗效和安全性，并确定哪种IBD患者亚型最适合主动TDM干预。
截至2023年7月，我们在PubMed、Embase和Cochrane图书馆中检索随机对照试验（RCT）和观察性研究，以比较抗TNF-α单克隆抗体联合主动TDM治疗与反应性TDM治疗或经验性治疗。采用成对和网状荟萃分析来确定实现临床缓解的IBD患者亚型，并确定手术需求。
排除后，本系统评价和荟萃分析纳入13项研究，基线指标均衡。我们发现ADA亚组[比值比（OR）=1.416，95%置信区间（CI）：1.196 - 1.676]和RCT亚组（OR = 1.393，95%CI：1.182 - 1.641）中实现临床缓解的患者数量显著增加，主动 - 反应性亚组（OR = 0.237，95%CI：0.101 - 0.558）和IFX + ADA亚组（OR = 0.137，95%CI：0.032 - 0.588）中需要手术的患者数量显著减少，根据成对荟萃分析，不良事件的总体风险降低（OR = 0.579，95%CI：0.391 - 0.858）。此外，网状荟萃分析结果表明，接受ADA治疗的IBD患者（OR = 1.39，95%CI：1.19 - 1.63）更有可能接受TDM，特别是与反应性TDM患者相比（OR = 1.38，95%CI：1.07 - 1.77）。
主动TDM更适合接受ADA治疗的IBD患者，且比反应性TDM具有明显优势。我们建议对接受ADA治疗的IBD患者采用主动TDM。
