Risk of venous thromboembolism in immune-mediated inflammatory diseases: a UK matched cohort study

Galloway, James; Barrett, Kevin; Irving, Peter M.; Khavandi, Kaivan; Nijher, Monica; Nicholson, R. G.; Lusignan, Simon de; Buch, Maya H

doi:10.1136/rmdopen-2020-001392

Cited by 27 publications

(32 citation statements)

References 38 publications

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“…Patients at the highest risk for VTE, such as older patients and those with multiple morbidities, may be underrepresented in the RCTs, so the extrapolation of findings among these populations must be done cautiously. This could explain the lower rate of VTEs in the placebo group (0.25 per 100 PEYs) compared to that reported in IMID observational studies (0.35 per 100 PEYs) (56).…”

Section: Discussionmentioning

confidence: 66%

Venous Thromboembolism Risk With JAK Inhibitors: A Meta‐Analysis

Yates

Mootoo

Adas

et al. 2021

Arthritis & Rheumatology

112

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Objective. JAK inhibitor therapies are effective treatment options for immune-mediated inflammatory diseases (IMIDs), but their use has been limited by venous thromboembolism (VTE) risk warnings from licensing authorities. We undertook this study to evaluate the VTE risk of JAK inhibitors in patients with IMIDs.Methods. Systematic searches of Medline and Embase databases from inception to September 30, 2020 were conducted. Phase II and phase III double-blind, randomized controlled trials (RCTs) of JAK inhibitors at licensed doses were included in our analyses. RCTs with no placebo arm, long-term extension studies, post hoc analyses, and pooled analyses were excluded. Three researchers independently extracted data on exposure to JAK inhibitors or placebo and VTE events (e.g., pulmonary embolism [PE] and deep vein thrombosis [DVT]) and assessed study quality.Results. A total of 42 studies were included, from an initial search that yielded 619. There were 6,542 JAK inhibitor patient exposure years (PEYs) compared to 1,578 placebo PEYs. There were 15 VTE events in the JAK inhibitor group and 4 in the placebo group. The pooled incidence rate ratios (IRRs) of VTE, PE, and DVT in patients receiving JAK inhibitors were 0.68 (95% confidence interval [95% CI] 0.36-1.29), 0.44 (95% CI 0.28-0.70), and 0.59 (95% CI 0.31-1.15), respectively.Conclusion. This meta-analysis of RCT data defines the VTE risk with JAK inhibitors as a class in IMID patients. The pooled IRRs do not provide evidence that support the current warnings of VTE risk for JAK inhibitors. These findings will aid continued development of clinical guidelines for the use of JAK inhibitors in IMIDs.

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Section: Discussionmentioning

confidence: 66%

Venous Thromboembolism Risk With JAK Inhibitors: A Meta‐Analysis

Yates

Mootoo

Adas

et al. 2021

Arthritis & Rheumatology

112

View full text Add to dashboard Cite

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“…8 Traditional CVD risk factors for VTE risk were evaluated in a study (pooled analysis of all immune-mediated diseases), which showed obesity and current smoking along with history of a fracture or cancer, glucocorticoids and oral contraceptives increased VTE risk. 5 It's important to note that these studies included both provoked and unprovoked VTE events. Although some adjusted their analyses for recent hospitalisations, major surgeries or cancer, it is hard to determine how much of the risk can be attributable to these heterogenous provoking factors versus other factors.…”

Section: Resultsmentioning

confidence: 99%

“… 3 4 This is supported by the evidence of increased VTE risk in various chronic inflammatory disorders. 5 Also, ASCVD and VTE share common mechanisms including endothelial dysfunction, blood flow changes, coagulation cascade and platelet aggregation activation, which are known to be intensified by chronic inflammation. 6 7 …”

Section: Introductionmentioning

confidence: 99%

Risk factors for venous thromboembolism and atherosclerotic cardiovascular disease: do they differ in patients with rheumatoid arthritis?

et al. 2021

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ObjectiveVenous thromboembolism (VTE) is an increasing concern in rheumatoid arthritis (RA) with little known about risk factors. We aimed to compare risk factors for unprovoked VTE and atherosclerotic cardiovascular disease (ASCVD) in patients with RA and to assess subsequent ASCVD risk after an unprovoked VTE.MethodsPeople with RA participating in a US-wide longitudinal observational registry from 1998 to 2018 were assessed for incident unprovoked VTE (deep venous thrombosis and pulmonary emboli not associated with cancer, recent surgery, hospitalisation, fracture and pregnancy) and ASCVD (myocardial infarction and stroke) validated from hospital/death records. Risk factors for VTE and ASCVD and the risk of ASCVD after an unprovoked VTE were determined using Cox proportional hazards models.ResultsDuring median (IQR) 4 (1.5–7) years of follow-up in 31 366 patients with RA, 539 unprovoked VTE and 1648 ASCVD events were identified. The adjusted models showed increased VTE and ASCVD risk with older age, male sex, comorbidities, prior fracture, worse disability, higher disease activity and glucocorticoids. Traditional cardiovascular disease risk factors were common in both ASCVD and VTE but only increased ASCVD risk with obesity as the exception (VTE HR (95% CI), 1.46 (1.13–1.87)) and ASCVD, 0.58 (0.50–0.68)). ASCVD risk doubled after an unprovoked VTE (HR (95% CI), 2.05 (1.43–2.95)).ConclusionOur findings suggest that unprovoked VTE is mediated by inflammation of RA and may be considered a spectrum of pan-cardiovascular syndrome.

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“…19 20 Studies using RCGP RSC have been published across many chronic diseases. [21][22][23][24] RCGP RSC is the primary infectious disease sentinel network for the UK, providing weekly infections data since 1967 to monitor trends in infectious disease and investigate real-world vaccine efficacy. 25 26 General practices within the network receive feedback on their coding of infectious diseases, which designates cases as first, new or ongoing, thereby differentiating incidence from prevalence.…”

Section: Data Sourcementioning

confidence: 99%

Risk of common infections in people with inflammatory bowel disease in primary care: a population-based cohort study

Irving

Lusignan

Tang

et al. 2021

BMJ Open Gastroenterol

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ObjectiveTo evaluate the risk of common infections in individuals with inflammatory bowel disease (IBD) [ulcerative colitis and Crohn’s disease] compared with matched controls in a contemporary UK primary care population.DesignMatched cohort analysis (2014–2019) using the Royal College of General Practitioners Research and Surveillance Centre primary care database. Risk of common infections, viral infections and gastrointestinal infections (including a subset of culture-confirmed infections), and predictors of common infections, were evaluated using multivariable Cox proportional hazards models.Results18 829 people with IBD were matched to 73 316 controls. People with IBD were more likely to present to primary care with a common infection over the study period (46% vs 37% of controls). Risks of common infections, viral infections and gastrointestinal infections (including stool culture-confirmed infections) were increased for people with ulcerative colitis and Crohn’s disease compared with matched controls (HR range 1.12–1.83, all p<0.001). Treatment with oral glucocorticoid therapy, immunotherapies and biologic therapy, but not with aminosalicylates, was associated with increased infection risk in people with IBD. Despite mild lymphopenia and neutropenia being more common in people with IBD (18.4% and 1.9%, respectively) than in controls (6.5% and 1.5%, respectively), these factors were not associated with significantly increased infection risk in people with IBD.ConclusionPeople with IBD are more likely to present with a wide range of common infections. Health professionals and people with IBD should remain vigilant for infections, particularly when using systemic corticosteroids, immunotherapies or biologic agents.Trial registration numberClinicaltrials.gov (NCT03835780).

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Risk of venous thromboembolism in immune-mediated inflammatory diseases: a UK matched cohort study

Cited by 27 publications

References 38 publications

Venous Thromboembolism Risk With JAK Inhibitors: A Meta‐Analysis

Venous Thromboembolism Risk With JAK Inhibitors: A Meta‐Analysis

Risk factors for venous thromboembolism and atherosclerotic cardiovascular disease: do they differ in patients with rheumatoid arthritis?

Risk of common infections in people with inflammatory bowel disease in primary care: a population-based cohort study

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