Incidence and Risk Factor Analysis of Thromboembolic Events in East Asian Patients With Inflammatory Bowel Disease, a Multinational Collaborative Study

Weng, Meng–Tzu; Park, Sang Hyoung; Matsuoka, Katsuyoshi; Tung, Chien‐Chih; Lee, Jae Yong; Chang, Chin‐Hao; Yang, Suk‐Kyun; Watanabe, Mamoru; Wong, Jau‐Min; Wei, Shu–Chen

doi:10.1093/ibd/izy058

Cited by 52 publications

(69 citation statements)

References 37 publications

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“…in the OLE study were those who completed OCTAVE Induction 1 and 2 without clinical response, and those who completed OCTAVE Sustain but were not in remission, or were early withdrawals due to treatment failure in OCTAVE Sustain. IRs for DVT and PE events with tofacitinib were comparable with those reported for patients with UC …”

Section: Discussionsupporting

confidence: 70%

“…e Severities were assessed as moderate (2) and severe (2). 24,26 The present post hoc analysis provides information for physicians regarding the incidence of DVT and PE in patients with UC who were treated with tofacitinib, but is limited by small sample size and drug exposure. Further studies of venous thromboembolism in patients with UC treated with tofacitinib are needed.…”

Section: Re Sultsmentioning

confidence: 99%

“…23 UC is a known risk factor for DVT/PE events, with reported IRs of 0.07-0.30 for DVT and 0.04-0.20 for PE. [24][25][26] We report incidence of venous thromboembolic events in the tofacitinib UC clinical development programme as of September 2018.…”

Section: Introductionmentioning

confidence: 99%

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Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme

Sandborn

Panés

Sands

et al. 2019

Aliment Pharmacol Ther

142

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Summary Background Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Aim To report incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in the tofacitinib UC programme. Methods DVT and PE were evaluated from one phase 2 and two phase 3 induction studies, one phase 3 maintenance study and an ongoing, open‐label, long‐term extension (OLE) study (September 2018 datacut). Data were analysed in induction, maintenance and overall (patients receiving ≥ 1 dose of tofacitinib 5 or 10 mg b.d. in any phase 2, 3 or OLE study) cohorts. Results 1157 patients (2404 patient‐years’ exposure; ≤ 6.1 years’ tofacitinib treatment) were evaluated in the overall cohort. In induction, one placebo‐treated patient had DVT and one had PE; no tofacitinib‐treated patients had DVT/PE. In maintenance, one placebo‐treated patient had DVT and one had PE; no tofacitinib‐treated patients had DVT/PE. In the overall cohort, one patient had DVT (incidence rate [patients with events/100 patient‐years; 95% CI]: 0.04 [0.00‐0.23]); four had PE (0.16 [0.04‐0.41]); all received predominant dose tofacitinib 10 mg b.d.; all had venous thromboembolism risk factors alongside UC. Conclusions In this post hoc analysis of patients with UC, during tofacitinib exposure, one patient had DVT and four had PE, all during the OLE study, on predominant dose 10 mg b.d. (83% of overall cohort patients received predominant dose 10 mg b.d.) with venous thromboembolism risk factors. This analysis is limited by small sample size and limited drug exposure; further studies are needed. ClinicalTrials.gov: NCT00787202, NCT01465763, NCT01458951, NCT01458574, NCT01470612.

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Section: Discussionsupporting

confidence: 70%

Section: Re Sultsmentioning

confidence: 99%

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Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme

Sandborn

Panés

Sands

et al. 2019

Aliment Pharmacol Ther

142

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“… 17 Our multinational collaborative study enrolled 2,562 hospitalized IBD patients from Korea, Japan and Taiwan showed the average incidence of VTE was 0.72–1.38 per 1,000 persons per year in East-Asian patients with IBD. 18 In Western patients with IBD, the overall incidence of VTE has been determined to be 2.4–2.6 per 1,000 persons per year. 10 11 Because of the relatively low incidence of VTE, the benefits of pharmacological prophylaxis are expected to be small in Asian patients with IBD.…”

mentioning

confidence: 99%

Should Asian inflammatory bowel disease patients need routine thromboprophylaxis?

2018

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“…A VTE prevalence of 2.3-25.3% in hospitalized patients with psychiatric disorders does not seem high compared to the VTE prevalence in hospitalized patients with nonpsychiatric disorders. [2][3][4] The prevalence of VTE has been reported at 0.5-58% in hospitalized non postsurgical patients with nonpsychiatric disorders, [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] and at 4.8-24.4% in those without VTE symptoms. 14,17,19,24 Given the recent increase in the number of people requiring hospitalization for VTE, clarifying the prevalence of VTE in hospitalized patients with psychiatric disorders such as depression is of academic as well as of clinical value.…”

Section: Introductionmentioning

confidence: 99%

<p>Prevalence of Asymptomatic Venous Thromboembolism in Depressive Inpatients</p>

Takeshima

Ishikawa

Y³

et al. 2020

NDT

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While depression has been recognized as a risk factor for venous thromboembolism (VTE), the prevalence of VTE in depressed inpatients has never been investigated. The aim of this study was thus to examine VTE prevalence and factors associated with VTE in depressed inpatients. Patients and Methods: We conducted a retrospective cross-sectional study of consecutive depressed inpatients (n = 94) from January 1, 2018, to June 30, 2019, at the psychiatry department of Akita University Hospital. As part of our clinical routine, depressed inpatients were screened for VTE using D-dimer, and patients who screened positive underwent enhanced CT to examine VTE. A variety of data was extracted from medical records, including, amongst others, age, sex, body mass index, diagnoses of psychiatric disorders, total scores on the 17-item Hamilton Depression Rating Scale, duration of current depressive episode, daily dosages of antidepressants and antipsychotics, catatonia, and physical restraint. Results: VTE was detected in 8.5% of depressed inpatients. There were no significant differences between VTE-positive and VTE-negative inpatients regarding any of the considered factors. Conclusion: Our analysis shows a VTE prevalence of 8.5% in depressed inpatients, higher than that of 2.3% reported in a previous study in hospitalized patients with psychiatric disorders including depression. This emphasizes the importance of VTE screening for depressive inpatients.

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Incidence and Risk Factor Analysis of Thromboembolic Events in East Asian Patients With Inflammatory Bowel Disease, a Multinational Collaborative Study

Cited by 52 publications

References 37 publications

Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme

Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme

Should Asian inflammatory bowel disease patients need routine thromboprophylaxis?

<p>Prevalence of Asymptomatic Venous Thromboembolism in Depressive Inpatients</p>

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