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描述成人特应性皮炎患者使用口服 Janus 激酶抑制剂的真实世界安全性概况:源自类风湿关节炎人群的证据转移。

Characterizing real world safety profile of oral Janus kinase inhibitors among adult atopic dermatitis patients: evidence transporting from the rheumatoid arthritis population.

机构信息

Department of Medicine, Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA, USA.

Sanofi, Bridgewater, NJ, USA.

出版信息

Curr Med Res Opin. 2022 Aug;38(8):1431-1437. doi: 10.1080/03007995.2022.2088715. Epub 2022 Jun 28.

Abstract

OBJECTIVE

To address potential safety concerns of Janus Kinase Inhibitors (JAK-Is), we characterized their safety profile in the atopic dermatitis (AD) patient population.

METHODS

In this retrospective observational study, we used propensity score-based methods and a Poisson modeling framework to estimate the incidence of health outcomes of interest (HOI) for the AD patient. To that end, two mutually exclusive cohorts were created using a real world data resource: a rheumatoid arthritis (RA) cohort, where we directly quantify the safety risk of JAK-Is on HOIs, and an AD cohort, that comprises the target population of interest and to whom we transport the results obtained from the RA cohort. The RA cohort included all adults who filled at least one prescription for a JAK-I (tofacitinib, baricitinib, or upadacitinib) between 1 January 2017 and 31 January 2020. The AD cohort consisted of all adults diagnosed with AD during the same period. We first estimated the incidence rate of each HOI in the RA cohort, and then transported the results to the AD population.

RESULTS

The RA and AD cohorts included 5,296 and 261,855 patients, respectively. On average, patients in the AD cohort were younger, more often male, more likely to be Asian, and had higher household income. They also had a lower prevalence of several comorbid conditions including hypertension, chronic kidney disease, obesity, and depression. Overall, the transported incidence rates of the HOIs to the AD cohort were lower than those obtained in the RA cohort by 13-50%.

CONCLUSION

We applied transportability methods to characterize the risk of the HOIs in the AD population and found absolute risks higher than that of the general population. Future work is needed to validate these conclusions in comparable populations.

摘要

目的

为了解决 Janus 激酶抑制剂(JAK-Is)的潜在安全问题,我们对特应性皮炎(AD)患者人群中的安全性概况进行了特征描述。

方法

在这项回顾性观察性研究中,我们使用倾向评分匹配方法和泊松建模框架来估计 AD 患者感兴趣的健康结果(HOI)的发生率。为此,我们使用真实世界数据资源创建了两个相互排斥的队列:一个是类风湿关节炎(RA)队列,我们在该队列中直接量化 JAK-Is 对 HOIs 的安全风险;另一个是 AD 队列,该队列包含目标人群,并将从 RA 队列中获得的结果应用于该队列。RA 队列包括在 2017 年 1 月 1 日至 2020 年 1 月 31 日期间至少开具过一种 JAK-I(托法替尼、巴瑞替尼或乌帕替尼)处方的所有成年人。AD 队列由同期诊断为 AD 的所有成年人组成。我们首先估计 RA 队列中每种 HOI 的发生率,然后将结果传输到 AD 人群。

结果

RA 队列和 AD 队列分别纳入了 5296 名和 261855 名患者。平均而言,AD 队列中的患者更年轻,更多为男性,更可能是亚裔,家庭收入更高。他们也有较低的几种合并症的患病率,包括高血压、慢性肾脏病、肥胖和抑郁症。总体而言,将 HOI 的传输发生率从 RA 队列应用于 AD 队列时,降低了 13%-50%。

结论

我们应用可转移性方法来描述 AD 人群中 HOI 的风险,发现绝对风险高于一般人群。需要在可比人群中进一步验证这些结论。

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