OBJECTIVE To determine, among patients with axial spondyloarthritis (axSpA), whether the risk of inflammatory bowel disease (IBD) varies between patients treated with biologic therapies and those treated with other therapies and, specifically, whether the risk is higher in patients treated with etanercept (ETN). METHODS The British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR-AS) was used to determine the incidence of IBD during follow-up and to calculate the incidence rate difference (IRD) per 1000 person-years (PY), between biologic treatment and other treatment groups. We then conducted a systematic review, involving observational studies and randomized controlled trials (RCTs), to perform a metaanalysis to quantify the difference in incidence of IBD between treatment groups. RESULTS According to the BSRBR-AS, among people with axSpA, exposure to biologic therapy was associated with an increased incidence of IBD compared to those who were not exposed to biologic therapy (IRD 11.9, 95% CI 4.3-19.6). This finding was replicated across observational studies but was not seen in placebo-controlled RCTs (IRD 2.2, 95% CI -4.1 to 8.5). Data from the BSRBR-AS do not suggest that excess incidence of IBD is associated with exposure to ETN compared to other anti-tumor necrosis factor (TNF) therapies (IRD -6.5, 95% CI -21.3 to 8.5). RCTs and their extensions suggest a small-yet not statistically significant-absolute increased incidence associated with ETN of between 2.1 and 5.8 per 1000 PY compared to other anti-TNF therapies. CONCLUSION There was an excess risk of IBD among persons treated with biologics in observational studies. Only evidence from RCTs suggested that ETN was associated with an increased risk compared to other anti-TNF therapies, albeit with considerable uncertainty.

中文翻译：

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使用 BSRBR-AS 和荟萃分析确定接受生物制剂治疗的中轴型脊柱关节炎患者的炎症性肠病风险。

目的 确定在中轴型脊柱关节炎 (axSpA) 患者中，炎症性肠病 (IBD) 的风险在接受生物疗法治疗的患者和接受其他疗法治疗的患者之间是否存在差异，特别是接受依那西普治疗的患者的风险是否更高（ETN）。方和其他治疗组。然后，我们进行了一项系统评价，包括观察性研究和随机对照试验 (RCT)，以进行荟萃分析以量化治疗组之间 IBD 发病率的差异。结果根据 BSRBR-AS，在 axSpA 患者中，与未接受生物治疗的患者相比，接受生物治疗与 IBD 发病率增加相关（IRD 11.9，95% CI 4.3-19.6）。这一发现在观察性研究中得到重复，但在安慰剂对照的 RCT 中未见（IRD 2.2，95% CI -4.1 至 8.5）。来自 BSRBR-AS 的数据并未表明与其他抗肿瘤坏死因子 (TNF) 疗法相比，IBD 的高发病率与暴露于 ETN 相关（IRD -6.5，95% CI -21.3 至 8.5）。随机对照试验及其扩展表明，与其他抗 TNF 疗法相比，与 ETN 相关的绝对发生率在每 1000 PY 2.1 至 5.8 例之间有小幅但无统计学意义的绝对增加。结论 在观察性研究中，接受生物制剂治疗的人患 IBD 的风险较高。