Objectives To better understand the real-world impact of biologic therapy in persons with Crohn’s disease (CD) and ulcerative colitis (UC), we evaluated the effect of marketplace introduction of infliximab on the population rates of hospitalisations and surgeries and public payer drug costs. Design We used health administrative data to study adult persons with CD and UC living in Ontario, Canada between 1995 and 2012. We used an interrupted time series design with segmented regression analysis to evaluate the impact of infliximab introduction on the rates of IBD-related hospitalisations, intestinal resections and public payer drug costs over 10 years among patients with CD and 5 years among patients with UC, allowing for a 1-year transition. Results Relative to what would have been expected in the absence of infliximab, marketplace introduction of infliximab did not produce significant declines in the rates of CD-related hospitalisations (OR at the last observation quarter 1.06, 95% CI 0.811 to 1.39) or intestinal resections (OR 1.10, 95% CI 0.810 to 1.50), or in the rates of UC-related hospitalisations (OR 1.22, 95% CI 1.07 to 1.39) or colectomies (OR 0.933, 95% CI 0.54 to 1.61). The findings were similar among infliximab users, except that hospitalisation rates declined substantially among UC patients following marketplace introduction of infliximab (OR 0.515, 95% CI 0.342 to 0.777). There was a threefold rise over expected trends in public payer drug cost among patients with CD following infliximab introduction (OR 2.98,95% CI 2.29 to 3.86), suggesting robust market penetration in this group, but no significant change among patients with UC (OR 1.06, 95% CI 0.955 to 1.18). Conclusions Marketplace introduction of infliximab has not yielded anticipated reductions in the population rates of IBD-related hospitalisations or intestinal resections, despite robust market penetration among patients with CD. Misguided use of infliximab in CD patients and underuse of infliximab in UC patients may largely explain our study findings.

中文翻译：

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引入抗 TNF 治疗并未使炎症性肠病的住院率和肠切除率预期下降：一项基于人群的间断时间序列研究

目的 为了更好地了解生物疗法对克罗恩病 (CD) 和溃疡性结肠炎 (UC) 患者的现实影响，我们评估了英夫利昔单抗的市场引入对住院和手术人口率以及公共支付药物成本的影响。设计 我们使用健康管理数据来研究 1995 年至 2012 年居住在加拿大安大略省的 CD 和 UC 成年患者。我们使用带有分段回归分析的间断时间序列设计来评估英夫利昔单抗引入对 IBD 相关住院率的影响、肠切除术和公共支付药物费用在 CD 患者中超过 10 年，在 UC 患者中超过 5 年，允许 1 年过渡。结果 相对于在没有英夫利昔单抗的情况下预期的结果，英夫利昔单抗的市场引入并未显着降低 CD 相关住院率（最后一个观察季度的 OR 为 1.06，95% CI 0.811 至 1.39）或肠切除术（OR 1.10，95% CI 0.810 至 1.50），或UC 相关住院率（OR 1.22，95% CI 1.07 至 1.39）或结肠切除术（OR 0.933，95% CI 0.54 至 1.61）。英夫利昔单抗使用者的研究结果相似，除了在市场引入英夫利昔单抗后，UC 患者的住院率大幅下降（OR 0.515，95% CI 0.342 至 0.777）。英夫利昔单抗引入后 CD 患者的公共支付药物成本比预期趋势高出三倍（OR 2.98,95% CI 2.29 至 3.86），表明该组的市场渗透率强劲，但在 UC 患者中没有显着变化（OR 1.06, 95% CI 0。955 到 1.18）。结论 尽管在 CD 患者中市场渗透率强劲，英夫利昔单抗的市场引入并未使 IBD 相关住院或肠切除术的人群发生率降低。CD 患者误用英夫利昔单抗和 UC 患者未充分使用英夫利昔单抗可能在很大程度上解释了我们的研究结果。