Background & Aims

Despite the increased numbers of older adults with inflammatory bowel diseases (IBDs), there are few studies regarding the safety and effectiveness of IBD treatments in older adults. The aim of this study was to compare the safety and effectiveness of anti–tumor necrosis factor (TNF)-α agents and vedolizumab in older adults with IBD.

Methods

We conducted a retrospective cohort study using an active comparator, new-user design for adults age 65 years and older with IBD initiating anti–TNF-α agents and vedolizumab in the Medicare claims database from 2014 to 2017. The primary safety outcome was infection-related hospitalization (excluding intra-abdominal and perianal abscesses). Co-primary outcomes to estimate effectiveness were IBD-related hospitalization, IBD-related surgery, and new corticosteroid use 60 days or more after biologic initiation. We performed propensity score weighting to control for confounding and estimated adjusted hazard ratios and 95% confidence intervals using standardized morbidity ratio–weighted variables.

Results

We identified 1152 anti–TNF-α new users and 480 vedolizumab new users. The median age was 71 years in both cohorts and 11% were age 80 years or older. Crohn’s disease patients comprised 54% of the anti–TNF-α cohort and 57% of the vedolizumab cohort. There was no significant difference in demographics, health care utilization, or frailty in both cohorts. More than half of both cohorts had a Charlson comorbidity index of 2 or higher. Vedolizumab users had a decreased risk of infection-related hospitalization (adjusted hazard ratio, 0.47; 95% confidence interval, 0.25–0.86). There was no significant difference in the outcomes approximating effectiveness.

Conclusions

Older IBD patients treated with vedolizumab had a lower risk of infection-related hospitalization compared with those initiating anti-TNFs. We observed no difference in effectiveness defined by hospitalizations, surgery, or new corticosteroid use.

中文翻译：

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在老年人中，与抗肿瘤坏死因子药物相比，维多珠单抗与较低的严重感染风险相关

背景与目标

尽管患有炎症性肠病 (IBD) 的老年人数量不断增加，但关于老年人 IBD 治疗的安全性和有效性的研究却很少。本研究的目的是比较抗肿瘤坏死因子 (TNF)-α 药物和维多珠单抗对患有 IBD 的老年人的安全性和有效性。

方法

我们对 2014 年至 2017 年 Medicare 索赔数据库中 65 岁及以上患有 IBD 初始抗 TNF-α 药物和维多珠单抗的成年人使用主动比较器、新用户设计进行了一项回顾性队列研究。主要安全性结果是感染-相关住院（不包括腹腔内和肛周脓肿）。评估有效性的共同主要结果是 IBD 相关住院、IBD 相关手术和生物制剂开始后 60 天或更长时间使用新皮质类固醇。我们进行了倾向评分加权以控制混杂，并使用标准化发病率加权变量估计调整后的风险比和 95% 置信区间。

结果

我们确定了 1152 名抗 TNF-α 新用户和 480 名维多珠单抗新用户。两个队列的中位年龄均为 71 岁，11% 的患者年龄在 80 岁或以上。克罗恩病患者占抗 TNF-α 队列的 54% 和维多珠单抗队列的 57%。两个队列在人口统计学、医疗保健利用或虚弱方面没有显着差异。两个队列中超过一半的 Charlson 合并症指数为 2 或更高。维多珠单抗使用者感染相关住院的风险降低（调整后的风险比，0.47；95% 置信区间，0.25–0.86）。近似有效性的结果没有显着差异。

结论

与开始使用抗肿瘤坏死因子的患者相比，接受维多珠单抗治疗的老年 IBD 患者感染相关住院的风险较低。我们没有观察到由住院、手术或新皮质类固醇使用定义的有效性差异。