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

Parakkal Deepak, Quazim A Alayo, Aava Khatiwada, Bixuan Lin, Marc Fenster, Christina Dimopoulos, Geoffrey Bader, Roni Weisshof, Michael Jacobs, Alexandra Gutierrez, Matthew A Ciorba, George P Christophi, Anish Patel, Robert P Hirten, Jean-Frederic Colombel, David T Rubin, Christina Ha, Poonam Beniwal-Patel, Ryan C Ungaro, Gaurav Syal, Joel Pekow, Benjamin L Cohen, Andres Yarur
Clinical Gastroenterology and Hepatology 2020 July 3

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 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.

RESULTS: 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).

CONCLUSIONS: 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.

Full Text Links

We have located links that may give you full text access.


You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read

Save your favorite articles in one place with a free QxMD account.


Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"