Long-Term Safety of Tofacitinib for Treatment of Moderate-to-Severe Ulcerative Colitis: Three Years of Korean National Data

Ulcerative colitis (UC) requires long-term treatment. Tofacitinib, a JAK inhibitor approved for UC, raises safety concerns regarding serious adverse events (SAEs) such as thromboembolism, major adverse cardiovascular events (MACEs), and opportunistic infections. This study aimed to evaluate the long...

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Published in:	Journal of Korean medical science Vol. 40; no. 39; pp. e259 - 9
Main Authors:	Song, Eun Mi, Seo, Gi Hyeon, Jung, Sung Hoon
Format:	Journal Article
Language:	English
Published:	Korea (South) 대한의학회 13.10.2025
Subjects:	Adult Aged Colitis, Ulcerative - drug therapy Colitis, Ulcerative - pathology Databases, Factual Female Herpes Zoster - epidemiology Humans Incidence Janus Kinase Inhibitors - adverse effects Janus Kinase Inhibitors - therapeutic use Male Middle Aged Piperidines - adverse effects Piperidines - therapeutic use Protein Kinase Inhibitors - adverse effects Protein Kinase Inhibitors - therapeutic use Pyrimidines - adverse effects Pyrimidines - therapeutic use Republic of Korea - epidemiology Risk Factors Severity of Illness Index Thromboembolism - epidemiology Thromboembolism - etiology Tumor Necrosis Factor Inhibitors - adverse effects Tumor Necrosis Factor Inhibitors - therapeutic use Young Adult 의학일반 Republic of Korea Cardiovascular Diseases Tofacitinib Ulcerative Colitis Infections Inflammatory Bowel Disease Safety Thromboembolism Korea
ISSN:	1011-8934, 1598-6357, 1598-6357
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Abstract	Ulcerative colitis (UC) requires long-term treatment. Tofacitinib, a JAK inhibitor approved for UC, raises safety concerns regarding serious adverse events (SAEs) such as thromboembolism, major adverse cardiovascular events (MACEs), and opportunistic infections. This study aimed to evaluate the long-term safety of tofacitinib versus anti-tumor necrosis factor (TNF) inhibitors in Korean patients with UC using a nationwide population-based cohort. We analyzed data from the National Health Insurance Service database from May 2019 to April 2022. Patients with UC were identified using the International Classification of Diseases, 10th revision and rare intractable disease codes. We compared the incidence of SAEs, including MACE, thromboembolic events, herpes zoster, tuberculosis, and malignancy, between the tofacitinib and anti-TNF inhibitor groups. The risk factors for SAEs in all patients with UC and tofacitinib users were also analyzed. A total of 1,816 patients with UC were included (521 treated with tofacitinib and 1,295 treated with anti-TNF inhibitors). The overall incidence of SAEs was similar between the tofacitinib and anti-TNF inhibitor groups (4.41/100 person-years vs. 5.33/100 person-years, = 0.332). Thromboembolic events, including MACE, pulmonary thromboembolism, and deep vein thrombosis, were comparable between the two groups ( = 0.151). The incidence of opportunistic infections (herpes zoster and tuberculosis) and malignancy did not differ significantly between the two groups. Among tofacitinib users, older age (≥ 60 years) and concomitant hypertension were significant risk factors for SAEs. Tofacitinib demonstrates a safety profile comparable to that of anti-TNF inhibitors in Korean patients with UC. Despite safety concerns, tofacitinib can be safely used in this population with caution in older patients and those with comorbidities.
AbstractList	Background: Ulcerative colitis (UC) requires long-term treatment. Tofacitinib, a JAK inhibitor approved for UC, raises safety concerns regarding serious adverse events (SAEs) such as thromboembolism, major adverse cardiovascular events (MACEs), and opportunistic infections. This study aimed to evaluate the long-term safety of tofacitinib versus anti-tumor necrosis factor (TNF) inhibitors in Korean patients with UC using a nationwide populationbased cohort. Methods: We analyzed data from the National Health Insurance Service database from May 2019 to April 2022. Patients with UC were identified using the International Classification of Diseases, 10th revision and rare intractable disease codes. We compared the incidence of SAEs, including MACE, thromboembolic events, herpes zoster, tuberculosis, and malignancy, between the tofacitinib and anti-TNF inhibitor groups. The risk factors for SAEs in all patients with UC and tofacitinib users were also analyzed. Results: A total of 1,816 patients with UC were included (521 treated with tofacitinib and 1,295 treated with anti-TNF inhibitors). The overall incidence of SAEs was similar between the tofacitinib and anti-TNF inhibitor groups (4.41/100 person-years vs. 5.33/100 personyears, P = 0.332). Thromboembolic events, including MACE, pulmonary thromboembolism, and deep vein thrombosis, were comparable between the two groups (P = 0.151). The incidence of opportunistic infections (herpes zoster and tuberculosis) and malignancy did not differ significantly between the two groups. Among tofacitinib users, older age (≥ 60 years) and concomitant hypertension were significant risk factors for SAEs. Conclusion: Tofacitinib demonstrates a safety profile comparable to that of anti-TNF inhibitors in Korean patients with UC. Despite safety concerns, tofacitinib can be safely used in this population with caution in older patients and those with comorbidities. KCI Citation Count: 0 Ulcerative colitis (UC) requires long-term treatment. Tofacitinib, a JAK inhibitor approved for UC, raises safety concerns regarding serious adverse events (SAEs) such as thromboembolism, major adverse cardiovascular events (MACEs), and opportunistic infections. This study aimed to evaluate the long-term safety of tofacitinib versus anti-tumor necrosis factor (TNF) inhibitors in Korean patients with UC using a nationwide population-based cohort. We analyzed data from the National Health Insurance Service database from May 2019 to April 2022. Patients with UC were identified using the International Classification of Diseases, 10th revision and rare intractable disease codes. We compared the incidence of SAEs, including MACE, thromboembolic events, herpes zoster, tuberculosis, and malignancy, between the tofacitinib and anti-TNF inhibitor groups. The risk factors for SAEs in all patients with UC and tofacitinib users were also analyzed. A total of 1,816 patients with UC were included (521 treated with tofacitinib and 1,295 treated with anti-TNF inhibitors). The overall incidence of SAEs was similar between the tofacitinib and anti-TNF inhibitor groups (4.41/100 person-years vs. 5.33/100 person-years, = 0.332). Thromboembolic events, including MACE, pulmonary thromboembolism, and deep vein thrombosis, were comparable between the two groups ( = 0.151). The incidence of opportunistic infections (herpes zoster and tuberculosis) and malignancy did not differ significantly between the two groups. Among tofacitinib users, older age (≥ 60 years) and concomitant hypertension were significant risk factors for SAEs. Tofacitinib demonstrates a safety profile comparable to that of anti-TNF inhibitors in Korean patients with UC. Despite safety concerns, tofacitinib can be safely used in this population with caution in older patients and those with comorbidities. Ulcerative colitis (UC) requires long-term treatment. Tofacitinib, a JAK inhibitor approved for UC, raises safety concerns regarding serious adverse events (SAEs) such as thromboembolism, major adverse cardiovascular events (MACEs), and opportunistic infections. This study aimed to evaluate the long-term safety of tofacitinib versus anti-tumor necrosis factor (TNF) inhibitors in Korean patients with UC using a nationwide population-based cohort.BACKGROUNDUlcerative colitis (UC) requires long-term treatment. Tofacitinib, a JAK inhibitor approved for UC, raises safety concerns regarding serious adverse events (SAEs) such as thromboembolism, major adverse cardiovascular events (MACEs), and opportunistic infections. This study aimed to evaluate the long-term safety of tofacitinib versus anti-tumor necrosis factor (TNF) inhibitors in Korean patients with UC using a nationwide population-based cohort.We analyzed data from the National Health Insurance Service database from May 2019 to April 2022. Patients with UC were identified using the International Classification of Diseases, 10th revision and rare intractable disease codes. We compared the incidence of SAEs, including MACE, thromboembolic events, herpes zoster, tuberculosis, and malignancy, between the tofacitinib and anti-TNF inhibitor groups. The risk factors for SAEs in all patients with UC and tofacitinib users were also analyzed.METHODSWe analyzed data from the National Health Insurance Service database from May 2019 to April 2022. Patients with UC were identified using the International Classification of Diseases, 10th revision and rare intractable disease codes. We compared the incidence of SAEs, including MACE, thromboembolic events, herpes zoster, tuberculosis, and malignancy, between the tofacitinib and anti-TNF inhibitor groups. The risk factors for SAEs in all patients with UC and tofacitinib users were also analyzed.A total of 1,816 patients with UC were included (521 treated with tofacitinib and 1,295 treated with anti-TNF inhibitors). The overall incidence of SAEs was similar between the tofacitinib and anti-TNF inhibitor groups (4.41/100 person-years vs. 5.33/100 person-years, P = 0.332). Thromboembolic events, including MACE, pulmonary thromboembolism, and deep vein thrombosis, were comparable between the two groups (P = 0.151). The incidence of opportunistic infections (herpes zoster and tuberculosis) and malignancy did not differ significantly between the two groups. Among tofacitinib users, older age (≥ 60 years) and concomitant hypertension were significant risk factors for SAEs.RESULTSA total of 1,816 patients with UC were included (521 treated with tofacitinib and 1,295 treated with anti-TNF inhibitors). The overall incidence of SAEs was similar between the tofacitinib and anti-TNF inhibitor groups (4.41/100 person-years vs. 5.33/100 person-years, P = 0.332). Thromboembolic events, including MACE, pulmonary thromboembolism, and deep vein thrombosis, were comparable between the two groups (P = 0.151). The incidence of opportunistic infections (herpes zoster and tuberculosis) and malignancy did not differ significantly between the two groups. Among tofacitinib users, older age (≥ 60 years) and concomitant hypertension were significant risk factors for SAEs.Tofacitinib demonstrates a safety profile comparable to that of anti-TNF inhibitors in Korean patients with UC. Despite safety concerns, tofacitinib can be safely used in this population with caution in older patients and those with comorbidities.CONCLUSIONTofacitinib demonstrates a safety profile comparable to that of anti-TNF inhibitors in Korean patients with UC. Despite safety concerns, tofacitinib can be safely used in this population with caution in older patients and those with comorbidities.
Author	Song, Eun Mi Seo, Gi Hyeon Jung, Sung Hoon
Author_xml	– sequence: 1 givenname: Eun Mi orcidid: 0000-0002-2428-1551 surname: Song fullname: Song, Eun Mi organization: Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea – sequence: 2 givenname: Gi Hyeon orcidid: 0000-0001-7414-0258 surname: Seo fullname: Seo, Gi Hyeon organization: Department of Healthcare Review and Assessment Committee, Health Insurance Review and Assessment Service, Wonju, Korea – sequence: 3 givenname: Sung Hoon orcidid: 0000-0001-9075-2027 surname: Jung fullname: Jung, Sung Hoon organization: Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
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Snippet	Ulcerative colitis (UC) requires long-term treatment. Tofacitinib, a JAK inhibitor approved for UC, raises safety concerns regarding serious adverse events... Background: Ulcerative colitis (UC) requires long-term treatment. Tofacitinib, a JAK inhibitor approved for UC, raises safety concerns regarding serious...
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SubjectTerms	Adult Aged Colitis, Ulcerative - drug therapy Colitis, Ulcerative - pathology Databases, Factual Female Herpes Zoster - epidemiology Humans Incidence Janus Kinase Inhibitors - adverse effects Janus Kinase Inhibitors - therapeutic use Male Middle Aged Piperidines - adverse effects Piperidines - therapeutic use Protein Kinase Inhibitors - adverse effects Protein Kinase Inhibitors - therapeutic use Pyrimidines - adverse effects Pyrimidines - therapeutic use Republic of Korea - epidemiology Risk Factors Severity of Illness Index Thromboembolism - epidemiology Thromboembolism - etiology Tumor Necrosis Factor Inhibitors - adverse effects Tumor Necrosis Factor Inhibitors - therapeutic use Young Adult 의학일반
Title	Long-Term Safety of Tofacitinib for Treatment of Moderate-to-Severe Ulcerative Colitis: Three Years of Korean National Data
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