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P407 Real-world safety of tofacitinib in inflammatory bowel diseases: a multi-centre study

A. Yarur*1, L. Bixuan1, P. Deepak2, A. Khatiwada2, G. Christophi2, M. Ciorba2, R. Ungaro3, M. Fenster3, C. Dimopoulos3, G. Syal4, R. Hirten3, J-F. Colombel3, C. Ha4, R. Weisshof5, J. Pekow5, A. Patel6, P. Beniwal-Patel1, B. Cohen3

1Medical College of Wisconsin, Gastroenterology, Milwaukee, USA, 2Washington University in St Louis School of Medicine, Gastroenterology, Saint Louis, USA, 3Icahn School of Medicine at Mount Sinai, Gastroenterology, New York, USA, 4CedarsSinai Medical Center, Gastroenterology, Los Angeles, USA, 5University of Chicago, Section of Gastroenterology, Hepatology, and Nutrition, Chicago, USA, 6Brooke Army Medical Center, Gastroenterology, Fort Sam Houston, USA

Background

Our aim was to examine adverse events (AEs) during real-world usage of tofacitinib in inflammatory bowel diseases (IBD).

Methods

A multi-centre cohort was assembled across six tertiary IBD centres in the US. Data on demographics, IBD-specific variables, concomitant medications and AEs (including herpes zoster [HZ], hyperlipidaemia and leukopoenia) were collected. AEs were defined as serious AE if life-threatening, resulting in a hospitalisation, disability or discontinuation of therapy. Abnormal lipid profile was defined as total cholesterol 200 mg/dl, LDL 130 mg/dl, HDL <40 mg/dl or triglycerides 150 mg/dl.

Results

A total of 140 IBD patients were analysed, 125 with UC, 11 Crohn’s disease (CD) and 4 IBD unclassified. Median age of the cohort was 36 years (interquartile range (IQR), 26–46) with a majority of males (77, 55%) and median follow-up 75.5 days (IQR, 49.8–124.5). A majority of patients (133, 95%) were initiated at 10 mg twice a day (bid) dose with 102 (72.9%) continuing therapy to date. Nineteen patients experienced an AE; of which, 8 (42.1%) were serious AE resulting in discontinuation of therapy: 5 with HZ, 2 with leukopoenia, and 1 with increased urinary frequency/incontinence. There were no significant differences in baseline characteristics between those with or without an AE (Table 1). Five patients (3.6%) initiated on 10 bid dose developed HZ at median age 30 years (range 16–47) and median time from initiation of Tofacitinib of 7 weeks (range, 5–24). Three of these patients were female while 2 each were African-American and Hispanic and 1 was Caucasian. Three of the 5 patients were on concomitant steroids and none had received Shingrix vaccine. The HZ was single-dermatome in 4 and multi-dermatome in 1 patient. One hundred and nine patients (77.9%) had baseline lipid levels checked with 73 (52.1%) having it repeated at Week 8. Nine out of 49 patients (18.4%) with previously normal lipids had abnormal lipids at 8 weeks of treatment at 10 mg twice a day (bid), 4 of whom were initiated on a statin. Other AEs reported include rash (1 patient) and joint pain (1 patient). Sixteen patients underwent surgery (4 CD, 12 UC) within 4 weeks of last dose of Tofacitinib. Five patients required readmission within 30 days of surgery (3 UC, 2 CD). Four patients (3 UC, 1 CD) had an infection within 30 days of surgery. No post-operative thrombotic complications or reoperations occurred within 30 days of surgery.

Conclusion

The safety profile of tofacitinib in IBD looks similar in real life to what has been observed in clinical trials. No new safety signal was detected.

Table 1. Comparison of baseline characteristics of patients with adverse events. *Missing data in 3; **missing data in 10; (a) Mann–Whitney test; (b) χ2 test; (c) Fisher exact test)

Characteristic*Adverse event, n = 19No adverse event, n = 121p-Value
Age at Tofacitinib initiation, mean (SD)*44.6 (17.7)36.2 (13.5)0.075a
Male sex, n (%)*10 (52.6)66 (55.9)0.79b
Caucasian race, n (%)9 (47.4)73 (61.9)0.23b
Body mass index, mean (SD)**27.7 (4.8)26.2 (6.1)0.21a
Tofacitinib induction dose at 10 mg bid, n (%)19 (100)114 (94.2)0.59c