P207: The Long-Term Safety of Tofacitinib as a Treatment for Moderate-to-Severe Ulcerative Colitis Based on Korean National Data

Poster Presenter

Sung Hoon Jung

Professor
The Catholic University of Korea
Korea, Republic of

Objectives

The study evaluating the safety of tofacitinib in Asian patients with ulcerative colitis is very limited, and there is particularly a lack of long-term data. We aimed to evaluate the safety of tofacitinib in moderate-to-severe ulcerative colitis.

Method

We investigated the incidence of serious adverse events (SAEs) in patients with ulcerative colitis using tofacitinib from the NHIS database for the period May 1, 2019, to April 30, 2022. (Tofacitinib was approved for the treatment of moderate-to-severe UC in Korea on May 1, 2019)

Results

From May 1, 2019 to April 30, 2022, The tofacitinib and anti-TNF inhibitor groups contained 521 (28.7%) and 1295 (71.3%) UC patients, respectively. Overall incidence rates of SAEs were 4.41/100 person-years (95% CI, 3.11–6.08) in the tofacitinib group and 5.33/100 person-years (95% CI, 4.27–6.56) in the anti-TNF inhibitor group. The incidence rate of overall thromboembolic events was not significantly different between the tofacitinib and anti-TNF inhibitor groups: 2.74/100 person-years (95% CI, 1.74–4.11) in the tofacitinib group and 3.87/100 person-years (95% CI, 2.98–4.95) in the anti-TNF inhibitor group, respectively (P = 0.151). The incidence of herpes zoster and TB infection did not differ between the tofacitinib and anti-TNF inhibitor groups. In addition, the incidence of malignancy also did not differ between the two groups. Among tofacitinib users, old age > 60 years and concomitant hypertension were the significant risk factors for SAE in the multivariate analysis.

Conclusion

Our study demonstrated that the overall risk of SAE was not significantly different between the tofacitinib group and the anti-TNF group. In addition, the risks of thromboembolic events, including MACE, PTE, and DVT, and of opportunistic infections were comparable between the tofacitinib and anti-TNF agent groups. Our findings indicate that, despite previous safety concerns, tofacitinib, as well as anti-TNF agents, can be safely used in Asian patients with UC. However, because the risk of SAE was reported to be increased in older patients with concomitant hypertension, tofacitinib should be used with caution