类固醇和肿瘤坏死因子拮抗剂联合治疗对克罗恩病诱导缓解的影响：系统评价和汇总分析。
Effect of Concomitant Therapy With Steroids and Tumor Necrosis Factor Antagonists for Induction of Remission in Patients With Crohn's Disease: A Systematic Review and Pooled Meta-analysis.
机构信息
Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York; Gastroenterology, Hepatology and Nutrition Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York; Division of Gastroenterology, Hepatology and Nutrition, University of Minnesota, Minneapolis, Minnesota.
出版信息
Clin Gastroenterol Hepatol. 2021 Feb;19(2):238-245.e4. doi: 10.1016/j.cgh.2020.06.036. Epub 2020 Jun 20.
BACKGROUND & AIMS: It is not clear whether concomitant therapy with corticosteroids and anti-tumor necrosis factor (TNF) agents is more effective at inducing remission in patients with Crohn's disease (CD) than anti-TNF monotherapy. We aimed to determine whether patients with active CD receiving corticosteroids during induction therapy with anti-TNF agents had higher rates of clinical improvement than patients not receiving corticosteroids during induction therapy.
METHODS
We systematically searched the MEDLINE, Embase, and CENTRAL databases, through January 20, 2016, for randomized trials of anti-TNF agents approved for treatment of CD and identified 14 trials (5 of adalimumab, 5 of certolizumab, and 4 of infliximab). We conducted a pooled meta-analysis of individual patient and aggregated data from these trials. We compared data from participants who continued oral corticosteroids during induction with anti-TNF therapy to those treated with anti-TNF agents alone. The endpoints were clinical remission (CD activity index [CDAI] scores <150) and clinical response (a decrease in CDAI of 100 points) at the end of induction (weeks 4-14 of treatment).
RESULTS
We included 4354 patients who received induction therapy with anti-TNF agents, including 1653 [38.0%] who were receiving corticosteroids. The combination of corticosteroids and an anti-TNF agent induced clinical remission in 32.0% of patients, whereas anti-TNF monotherapy induced clinical remission in 35.5% of patients (odds ratio [OR], 0.93; 95% CI, 0.74-1.17). The combination of corticosteroids and an anti-TNF agent induced a clinical response in 42.7% of patients, whereas anti-TNF monotherapy induced a clinical response in 46.8% (OR 0.84; 95% CI, 0.73-0.96). These findings did not change with adjustment for baseline CDAI scores and concurrent use of immunomodulators.
CONCLUSIONS
Based on a meta-analysis of data from randomized trials of anti-TNF therapies in patients with active CD, patients receiving corticosteroids during induction therapy with anti-TNF agents did not have higher rates of clinical improvement compared with patients not receiving corticosteroids during induction therapy. Given these findings and the risks of corticosteroid use, clinicians should consider early weaning of corticosteroids during induction therapy with anti-TNF agents for patients with corticosteroid-refractory CD.
背景与目的
目前尚不清楚在接受抗 TNF 治疗的克罗恩病（CD）患者中，皮质激素联合抗 TNF 治疗是否比单独使用抗 TNF 治疗更能诱导缓解。我们旨在确定在接受抗 TNF 诱导治疗期间接受皮质激素治疗的活动期 CD 患者的临床改善率是否高于未接受皮质激素诱导治疗的患者。
方法
我们通过系统检索 MEDLINE、Embase 和 CENTRAL 数据库，截至 2016 年 1 月 20 日，确定了批准用于治疗 CD 的抗 TNF 药物的随机试验，并鉴定了 14 项试验（5 项阿达木单抗，5 项 Certolizumab，4 项英夫利昔单抗）。我们对这些试验的个体患者和汇总数据进行了荟萃分析。我们比较了在接受抗 TNF 治疗诱导期间继续接受口服皮质激素治疗的参与者与单独接受抗 TNF 药物治疗的参与者的数据。终点是诱导结束时（治疗的第 4-14 周）的临床缓解（CD 活动指数[CDAI]评分<150）和临床反应（CDAI 下降 100 分）。
结果
我们纳入了 4354 例接受抗 TNF 药物诱导治疗的患者，其中 1653 例（38.0%）正在接受皮质激素治疗。皮质激素联合抗 TNF 药物诱导缓解的患者为 32.0%，而单独使用抗 TNF 药物诱导缓解的患者为 35.5%（比值比[OR]，0.93；95%CI，0.74-1.17）。皮质激素联合抗 TNF 药物诱导临床反应的患者为 42.7%，而单独使用抗 TNF 药物诱导临床反应的患者为 46.8%（OR 0.84；95%CI，0.73-0.96）。这些发现并未因调整基线 CDAI 评分和同时使用免疫调节剂而改变。
结论
基于对活动期 CD 患者接受抗 TNF 治疗的随机试验数据的荟萃分析，在接受抗 TNF 诱导治疗期间接受皮质激素治疗的患者与未接受皮质激素诱导治疗的患者相比，临床改善率没有更高。鉴于这些发现和皮质激素使用的风险，对于皮质激素难治性 CD 患者，临床医生应考虑在抗 TNF 诱导治疗期间早期逐渐停用皮质激素。
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