Safety of Tofacitinib in a Real-World Cohort of Patients With Ulcerative Colitis

Abstract

BACKGROUND & AIMS: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. METHODS:We collected data from 260 patients with UC in the Tofacitinib Real-world Outcomes in Patients with ulceratIve colitis and Crohn's disease consortium study, performed at 6 medical centers in the United States. Patients were followed up for a median of 6 months (interquartile range, 2.7-11.5 mo). AEs were captured using a standardized data collection instrument before study

S0897 Efficacy and Safety of Combining Tofacitinib With a Biologic in Patients With Refractory Inflammatory Bowel Diseases

“…11,13 Furthermore, the incidence rate of AE (20.7/100 PYF) reported here is lower than what we reported in our recently published realworld study of tofacitinib monotherapy in UC (IR: 27.2 (95% CI, 24.4-30.7) /100 PYF. 29 Similarly, the proportion of patients with SAE in our TBT cohort is also lower compared to these previous tofacitinib monotherapy studies. This unexpected finding is likely due to differences in the definition and monitoring of AE between clinical trials and real-world data in our study as well as the relatively shorter duration of follow-up in the current study.…”

Effectiveness and Safety of Combining Tofacitinib with a Biologic in Patients with Refractory Inflammatory Bowel Diseases

“…11, 13 Furthermore, the incidence rate of AE (20.7/100 PYF) reported here is lower than what we reported in our recently published real-world study of tofacitinib monotherapy in UC (IR: 27.2 (95% CI, 24.4–30.7) /100 PYF. 29 Similarly, the proportion of patients with SAE in our TBT cohort is also lower compared to these previous tofacitinib monotherapy studies. This unexpected finding is likely due to differences in the definition and monitoring of AE between clinical trials and real-world data in our study as well as the relatively shorter duration of follow-up in the current study.…”

Biomarker dynamics during infliximab salvage for acute severe ulcerative colitis: C-reactive protein (CRP)-lymphocyte ratio and CRP-albumin ratio are useful in predicting colectomy

“…17,26 Our study has highlighted the difference in biomarker dynamics between patients who required and avoided colectomy and demonstrated the potential utility of CAR and CLR early in the treatment course (day 3 post salvage) in predicting infliximab failure. With the expansion of efficacious treatments such as newer biologic therapies and small molecule inhibitors, [27][28][29][30] the ability to predict disease trajectory in ASUC should inform treatment choice-for example, a patient who is likely to require longer term colectomy despite infliximab salvage may warrant more proactive optimization of maintenance therapy with a biologic agent (a top-down approach), while patients with a lower risk of colectomy may only require conventional therapy. [31][32][33] Although the ability to continue biologic therapy in all patients may appear attractive, a careful risk-benefit assessment should be made given such a strategy introduces an additional risk of infections and may not be cost-effective.…”