Safety of Tofacitinib in a Real-World Cohort of Patients With Ulcerative Colitis.
Safety of Tofacitinib in a Real-World Cohort of Patients With Ulcerative Colitis.
复制标题
DOI：
10.1016/j.cgh.2020.06.050
复制
发表时间：
2021-08
期刊：
影响因子：
--
通讯作者：
Yarur A
中科院分区：
文献类型：
--
作者：
Deepak P;Alayo QA;Khatiwada A;Lin B;Fenster M;Dimopoulos C;Bader G;Weisshof R;Jacobs M;Gutierrez A;Ciorba MA;Christophi GP;Patel A;Hirten RP;Colombel JF;Rubin DT;Ha C;Beniwal-Patel P;Ungaro RC;Syal G;Pekow J;Cohen BL;Yarur A
托法替尼治疗溃疡性结肠炎（UC）的临床试验报告了包括带状疱疹（HZ）复发和静脉血栓栓塞（VTE）在内的不良事件（AE）。我们在接受托法替尼治疗的UC患者的真实世界研究中调查了AE的发生率。我们在TROPIC联盟研究中收集了260例UC患者的数据，该研究在美国的6个医疗中心进行。患者随访的中位时间为6个月（四分位距，2.7-11.5个月）。在研究开始前和第8、16、26、39和52周，使用标准化数据收集工具采集AE。严重AE定义为危及生命或导致住院、残疾或治疗中止。进行Logistic回归以检查AE的风险因素。41例患者（15.7%）发生AE;大多数为感染（N = 13，5.0%）。任何AE的发生率为27.2 [95% CI，24.4-30.7/100随访患者年（PYF）]。15例为严重AE（占AE的36.6%），12例患者停用托法替布（占队列的4.6%）。严重AE的发生率为10.0（95% CI，8.9-11.2/100 PYF）。5例患者发生HZ感染，2例发生VTE（均接受10 mg托法替尼，每日2次）。托法替尼的真实世界安全性信号与临床试验相似，近16%的患者报告了AE。接受10 mg托法替尼每日两次治疗的患者发生HZ感染和VTE。这些结果支持诱导治疗后剂量递减，以降低AE风险。
Adverse events (AEs) including reactivation of herpes zoster (HZ) and venous thromboembolism (VTE) have been reported from clinical trials of tofacitinib in ulcerative colitis (UC). We investigated the incidence rates of AEs in a real-world study of UC patients given tofacitinib. We collected data from 260 patients with UC in the TROPIC consortium study, performed at 6 medical centers in the United States. Patients were followed for a median time of 6 months (interquartile range, 2.7–11.5 months). AEs were captured using a standardized data collection instrument before study initiation and at weeks 8, 16, 26, 39, and 52. Serious AEs were defined as life-threatening or resulting in a hospitalization, disability, or discontinuation of therapy. Logistic regression was performed to examine risk factors for AEs. AEs occurred in 41 patients (15.7%); most were infections (N = 13, 5.0%). The incidence rate of any AE was 27.2 [95% CI, 24.4–30.7 per 100 patient-years of follow up (PYF)]. Fifteen were serious AEs (36.6% of AEs), and tofacitinib was discontinued for 12 patients (4.6% of cohort). The incidence rates of serious AE was 10.0 (95% CI, 8.9–11.2 per 100 PYF). Five patients developed HZ infection and 2 developed VTE (all receiving 10 mg tofacitinib, twice per day). Real-world safety signals for tofacitinib are similar to those for clinical trials, with AEs reported from almost 16% of patients. HZ infection and VTE occurred in patients receiving 10 mg tofacitinib twice per day. These results support dose de-escalation after induction therapy, to reduce the risk of AEs.
登录
查看更多内容
影响因子：
7.6
作者：
Sandborn, William J.;Panes, Julian;Danese, Silvio
通讯作者：
Danese, Silvio
影响因子：
12.6
作者：
Sandborn, William J.;Panes, Julian;Chan, Gary
通讯作者：
Chan, Gary
影响因子：
7.6
作者：
Sands, Bruce E.;Armuzzi, Alessandro;Marshall, John K.;Lindsay, James O.;Sandborn, William J.;Danese, Silvio;Panes, Julian;Bressler, Brian;Colombel, Jean-Frederic;Lawendy, Nervin;Maller, Eric;Zhang, Haiying;Chan, Gary;Salese, Leonardo;Tsilkos, Konstantinos;Marren, Amy;Su, Chinyu
通讯作者：
Su, Chinyu
影响因子：
158.5
作者：
Sandborn, William J.;Su, Chinyu;Panes, Julian
通讯作者：
Panes, Julian
影响因子：
158.5
作者：
Sandborn, William J.;Ghosh, Subrata;Niezychowski, Wojciech
通讯作者：
Niezychowski, Wojciech