REMIT-UC: Real-World Effectiveness and Safety of Tofacitinib for Moderate-to-Severely Active Ulcerative Colitis A Canadian IBD Research Consortium Multicenter National Cohort Study

被引：25

作者：

Ma, Christopher ^{[1
,2
,3
]}

Panaccione, Remo ^{[1
]}

Xiao, Yasi ^{[4
]}

Khandelwal, Yuvan ^{[5
]}

Murthy, Sanjay K. ^{[6
,7
]}

Wong, Emily C. L. ^{[8
]}

Narula, Neeraj ^{[8
]}

Tsai, Catherine ^{[9
]}

Peerani, Farhad ^{[9
]}

Reise-Filteau, Marica ^{[10
]}

Bressler, Brian ^{[10
]}

Starkey, Samantha Y. ^{[11
]}

Loomes, Dustin ^{[12
]}

Sedano, Rocio ^{[3
]}

Jairath, Vipul ^{[3
,13
,14
,15
]}

Bessissow, Talat ^{[16
]}

机构：

[1] Univ Calgary, Dept Med, Div Gastroenterol & Hepatol, Calgary, AB, Canada

[2] Univ Calgary, Dept Community Hlth Sci, Calgary, AB, Canada

[3] Alimentiv Inc, London, ON, Canada

[4] Univ Toronto, Div Gastroenterol & Hepatol, Toronto, ON, Canada

[5] Univ Ottawa, Fac Med, Ottawa, ON, Canada

[6] Ottawa Hosp, IBD Ctr, Ottawa, ON, Canada

[7] Univ Ottawa, Dept Med, Ottawa, ON, Canada

[8] McMaster Univ, Div Gastroenterol, Hamilton, ON, Canada

[9] Univ Alberta, Dept Med, Div Gastroenterol, Edmonton, AB, Canada

[10] Univ British Columbia, Div Gastroenterol, Vancouver, BC, Canada

[11] Univ British Columbia, Fac Med, Vancouver, BC, Canada

[12] Univ British Columbia, Royal Jubilee Hosp, Vancouver Isl IBD Clin, Pacific Digest Hlth, Victoria, BC, Canada

[13] Western Univ, London Hlth Sci Ctr, Dept Med, Div Gastroenterol, London, ON, Canada

[14] Western Univ, Dept Epidemiol, London, ON, Canada

[15] Western Univ, Dept Biostat, London, ON, Canada

[16] McGill Univ, Hlth Ctr, Div Gastroenterol, Dept Med, Montreal, PQ, Canada

来源：

AMERICAN JOURNAL OF GASTROENTEROLOGY | 2023年 / 118卷 / 05期

关键词：

colitis; effectiveness; Janus kinase; safety; ofacitinib; ACTIVATION;

D O I：

10.14309/ajg.0000000000002129

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

INTRODUCTION: We aimed to evaluate the real-world effectiveness and safety of tofacitinib for the treatment of ulcerative colitis (UC).METHODS: REMIT-UC is a Canadian multicenter cohort study. Standardized data collection was performed on 334 consecutive adult outpatients with UC treated with tofacitinib. The primary outcomes were achievement of clinical and endoscopic remission. Safety outcomes were reported using incidence rates (events/100 patient-years of exposure). A multivariable Cox proportional hazards model was used to evaluate predictors of loss of response after tofacitinib dose de-escalation to 5 mg twice daily (BID).RESULTS: Clinical remission was achieved by 35.3% (106/300), 36.0% (104/289), and 35.2% (93/264) of patients at weeks 12, 24, and 52, respectively. Endoscopic remission was achieved by 18.5% (15/81), 23.0% (28/122), and 25.7% (35/136) of patients at weeks 12, 24, and 52, respectively. Incidence of serious infections, herpes zoster, and venous thromboembolism were 2.1 [0.9-4.2], 0.5 [0.1-1.9], and 1.1 [0.3-2.7], respectively. Among responders, 44.5% (109/245) lost response during follow-up, which was recaptured in 54.9% (39/71) of patients who re-escalated to 10 mg BID. Patients with a baseline Mayo endoscopic score of 3 (adjusted hazard ratio 3.60 [95% confidence interval: 1.70-7.62]) and prior biologic failure (adjusted hazard ratio 3.89 [95% confidence interval: 1.28-11.86]) were at a higher risk for losing response after dose reduction.DISCUSSION: One-third of patients with UC treated with tofacitinib achieved clinical remission with few serious adverse events. However, half of patients lost response with de-escalation, which was only partially recaptured with increasing the maintenance dose. Those with negative prognostic factors should be counselled about the risks and benefits of continuing high doses of tofacitinib.

引用

页码：861 / 871

页数：11

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