Risk of Venous Thromboembolism After Hospital Discharge in Patients With Inflammatory Bowel Disease: A Population-based Study

McCurdy, Jeffrey D.; Kuenzig, M Ellen; Smith, Geoffrey C.; Spruin, Sarah; Murthy, Sanjay K.; Carrier, Marc; Nguyen, Geoffrey C.; Benchimol, Eric I

doi:10.1093/ibd/izaa002

Cited by 38 publications

(31 citation statements)

References 29 publications

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“…As the burden of TE events remains a substantial public health concern, it is important to continue to examine the strength of this potential safety signal in real-world data. This is particularly true for JAKinibs since they are indicated for, and commonly prescribed to, patients experiencing a broad range of IMDs, such as rheumatoid and psoriatic arthritis as well as UC, all of which already have a high background risk for TEs [18][19][20][21].…”

Section: Data Cleaning Proceduresmentioning

confidence: 99%

Reporting of Thromboembolic Events with JAK Inhibitors: Analysis of the FAERS Database 2010–2019

et al. 2021

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Introduction A potentially elevated risk for pulmonary thrombosis with Janus kinase inhibitors (JAKinibs) was identified, as well as an increased risk for portal vein thrombosis, in ruxolitinib patients. Consequently, the objective of this investigation was to repeat a comprehensive analysis of the US FDA's Adverse Event Reporting System (FAERS) database to assess postmarketing reporting rates of thromboembolic events (TEs) in patients treated with JAKinibs. Methods FAERS data (1 January 2010 to 30 September 2019) were searched for reports of all FDA-approved JAKinibs across all indications. For each drug-adverse drug reaction (ADR) pair, the reporting odds ratio (ROR) [two-sided 95% confidence interval (CI)] and empirical Bayesian geometric mean (EBGM) [one-sided 95% lower bound] were calculated to detect drug-ADR pairs with higher-than-expected reporting rates within the FAERS. Significance was declared when both lower 95% CI bounds were > 1. Results Significantly elevated reporting rates of pulmonary thrombosis were evident with tofacitinib ]; EBGM 2.01 [1.53]), as was pulmonary embolism with baricitinib EBGM 7.72 [3.82]) and portal vein thrombosis with ruxolitinib ]; EBGM 4.52 [3.11]). Deep vein thrombosis reports were increased with baricitinib EBGM 9.49 [5.91]), as was thrombosis with ruxolitinib ]; EBGM 1.72 [1.52]). The relationship between the time of treatment initiation and event occurrence indicated that time to events occurred randomly. Conclusions This study found significant reporting rates for TEs in patients treated with JAKinibs across brands and indications, providing additional evidence that JAKinibs may be contraindicated in patients at risk of TEs.

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Section: Data Cleaning Proceduresmentioning

confidence: 99%

Reporting of Thromboembolic Events with JAK Inhibitors: Analysis of the FAERS Database 2010–2019

et al. 2021

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“…However, the lowest incidence was seen in patients with CD (1.2%). Similarly, McCurdy et al [ 93 ] reported that the cumulative incidence of VTE at 1 mo after discharge was higher in surgical patients with UC (HR: 1.68; 95%CI: 1.16–2.45) but not in surgical patients with CD. In UC patients, the risk of VTE is mostly higher in patients after colectomy[ 94 , 95 ].…”

Section: Risk Factors Of Thromboembolic Complications In Ibdmentioning

confidence: 90%

“…Finally, it is well known that surgery represents a major risk factor for VTE, particularly in patients with IBD, and thromboprophylaxis is universally performed from the day of surgery to discharge. However, as reported before, in the IBD patient population, colorectal surgery is related to an additional VTE risk, including post-discharge period[ 93 , 95 ]. Recent meta-analyses in the United States indicated that IBD patients undergoing colorectal surgery were at a higher in-hospital and post-discharge risk for postoperative VTE compared to non-IBD patients undergoing surgery for colorectal cancer[ 91 , 99 ].…”

Section: Prophylaxis Of Vte In Ibdmentioning

confidence: 90%

“…Another question arises whether thromboprophylaxis should be extended after hospitalization to IBD patients with a higher risk for VTE. In a recent population-based study, McCurdy et al [ 93 ] found that surgical IBD patients with UC and non-surgical IBD patients were 1.7-fold more likely to develop post-discharge VTE than non-IBD matched controls. These authors showed that the risk score of post-discharge VTE for IBD patients included age over 45 years and the length of admission (more than 7 d), which would indicate prolonged post-hospitalization VTE prophylaxis.…”

Section: Prophylaxis Of Vte In Ibdmentioning

confidence: 99%

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Venous and arterial thromboembolism in patients with inflammatory bowel diseases

Stadnicki¹,

Stadnicka²

2021

WJG

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The risk of thromboembolism (TE) is increased in patients with inflammatory bowel disease (IBD), mainly due to an increased risk of venous TE (VTE). The risk of arterial TE (ATE) is less pronounced, but an increased risk of cardiovascular diseases needs to be addressed in IBD patients. IBD predisposes to arterial and venous thrombosis through similar prothrombotic mechanisms, including triggering activation of coagulation, in part mediated by impairment of the intestinal barrier and released bacterial components. VTE in IBD has clinical specificities, i.e. , an earlier first episode in life, high rates during both active and remission stages, higher recurrence rates, and poor prognosis. The increased likelihood of VTE in IBD patients may be related to surgery, the use of medications such as corticosteroids or tofacitinib, whereas infliximab is antithrombotic. Long-term complications of VTE can include post-thrombotic syndrome and high recurrence rate during post-hospital discharge. A global clot lysis assay may be useful in identifying patients with IBD who are at risk for TE. Many VTEs occur in IBD outpatients; therefore, outpatient prophylaxis in high-risk patients is recommended. It is crucial to continue focusing on prevention and adequate treatment of VTE in patients with IBD.

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“…The risk of lymphoma is increased in RA and especially so in patients most severely affected by RA, namely, those who may have the greatest need for TNF blockers. In addition, the background risk of VTE is also increased in other diseases for which jakinibs are approved, such as ulcerative colitis [39] and psoriatic arthritis [36].…”

Section: Jak Thrombosismentioning

confidence: 99%

Safety of Janus Kinase Inhibitors in Older Patients: A Focus on the Thromboembolic Risk

2020

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The Janus kinase (JAK)-signal transducer and activator of transcription (STAT) pathway is a membrane-to-nucleus signaling cascade that effects activation of gene transcription. JAK inhibitors have demonstrated effectiveness in autoimmune diseases such as rheumatoid arthritis. An increased risk of infection, mainly varicella-zoster reactivation, with these new agents is of concern. Comorbid conditions, along with pharmacokinetic variations in drug metabolism in the older population, further increase the risk of adverse outcomes. Newly raised concerns for potential adverse effects such as deep vein thrombosis and pulmonary embolism are essential considerations for clinicians. Older patients are at increased risk because of multiple comorbid conditions and pharmacokinetic changes related to drug metabolism and excretion. Both the US FDA and the European Medicines Agency have issued warnings regarding this risk. These warnings highlight individuals aged > 50 years with concomitant cardiovascular risk factors. Furthermore, the FDA released a black box warning for increased thromboembolic risk associated with JAK inhibitors. As the use of these drugs increases, a solid understanding of adverse effects and risks is critical to those treating older adults. Key Points Thromboembolic risk is an important and emerging consideration for clinicians who prescribe Janus kinase (JAK) inhibitors. Older patients with rheumatoid arthritis are at increased thromboembolic risk because of age and comorbid conditions. The warnings issued by the US FDA and the European Medicines Agency highlight this risk. Infectious complications, such as herpes zoster, are known and essential considerations.

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Risk of Venous Thromboembolism After Hospital Discharge in Patients With Inflammatory Bowel Disease: A Population-based Study

Cited by 38 publications

References 29 publications

Reporting of Thromboembolic Events with JAK Inhibitors: Analysis of the FAERS Database 2010–2019

Reporting of Thromboembolic Events with JAK Inhibitors: Analysis of the FAERS Database 2010–2019

Venous and arterial thromboembolism in patients with inflammatory bowel diseases

Safety of Janus Kinase Inhibitors in Older Patients: A Focus on the Thromboembolic Risk

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