Philippoteaux Cécile, Deprez Valentine, Nottez Aurore, Cailliau Emeline, Houvenagel Eric, Deprez Xavier, Philippe Peggy, Pascart Tristan, Flipo René-Marc, Goëb Vincent, Letarouilly Jean-Guillaume
Department of Rheumatology, Lille University Hospital, 59000 Lille, France.
Department of Rheumatology, Amiens University Hospital, 80000 Amiens, France.
J Clin Med. 2022 Dec 27;12(1):207. doi: 10.3390/jcm12010207.
Baricitinib (BARI) or Tofacitinib (TOFA) were the first Janus Kinase Inhibitors (JAKi) to be marketed in rheumatoid arthritis (RA). Concerns regarding venous thromboembolism (VTE) risk have emerged during the past years. The aim of the study was to compare the baseline characteristics of patients initiating BARI or TOFA in RA before versus after European Medicine Agency (EMA)'s VTE warnings and to compare real-world persistence with these two drugs.
In this multicentric cohort study, RA patients initiating BARI or TOFA were included from October 2017, date of BARI marketing authorization in France, to September 2020. Baseline characteristics regarding VTE risk were compared (before vs. after May 2019) by using pre-specified statistical tests. Comparison of persistence was assessed by using propensity-score methods.
232 patients were included; 155 with BARI and 77 with TOFA. Baseline characteristics of patients regarding VTE risk factors were not statistically different when Janus Kinase inhibitor (JAKi) was initiated before vs. after EMA's warnings although a trend towards a lower proportion of VTE history was observed. Five VTE events occurred, four with BARI, one with TOFA. Cumulative persistence rate at 2 years was similar between BARI and TOFA: HR 0.96; 95% Cl: 0.52 to 1.74; = 0.89.
Our study did not show a significant change in patients characteristics starting a JAKi after the EMA's warnings, probably due to a lack of power. Though, the lower proportion of VTE history in patients after May 2019 suggests that rheumatologists have taken into account the potential VTE risk. These results need to be confirmed by further evidence.
巴瑞替尼（BARI）和托法替布（TOFA）是首批在类风湿关节炎（RA）中上市的Janus激酶抑制剂（JAKi）。在过去几年中，人们对静脉血栓栓塞（VTE）风险的担忧日益凸显。本研究的目的是比较在欧洲药品管理局（EMA）发布VTE警告之前和之后开始使用BARI或TOFA治疗RA的患者的基线特征，并比较这两种药物在现实世界中的持续使用情况。
在这项多中心队列研究中，纳入了2017年10月（BARI在法国获得上市许可的日期）至2020年9月开始使用BARI或TOFA的RA患者。通过预先设定的统计检验比较VTE风险的基线特征（2019年5月之前与之后）。使用倾向评分法评估持续使用情况的比较。
共纳入232例患者；其中155例使用BARI，77例使用TOFA。尽管观察到VTE病史比例有降低趋势，但在EMA发布警告之前和之后开始使用Janus激酶抑制剂（JAKi）时，患者VTE风险因素的基线特征无统计学差异。发生了5例VTE事件，4例与BARI相关，1例与TOFA相关。BARI和TOFA在2年时的累积持续使用率相似：风险比（HR）为0.96；95%置信区间（Cl）：0.52至1.74；P = 0.89。
我们的数据显示，在EMA发布警告后开始使用JAKi的患者特征无显著变化，可能是由于样本量不足。不过，2019年5月之后患者中VTE病史比例较低，这表明风湿病学家已考虑到潜在VTE风险。这些结果需要进一步证据来证实。
