Incidence of Venous Thromboembolism in Patients With Dermatologist-Diagnosed Chronic Inflammatory Skin Diseases

Schneeweiss, Maria C.; Kim, Seo Young; Wyss, Richard; Jin, Yinzhu; Chin, Kristyn; Merola, Joseph F.; Mostaghimi, Arash; Silverberg, Jonathan I.; Schneeweiß, Sebastian

doi:10.1001/jamadermatol.2021.1570

Cited by 26 publications

(45 citation statements)

References 61 publications

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“…No increase [27,62,63] Increased; IR 0.93-0.99/100 PY [64,65] Risk of VTE Increased; IR of 0.33-0.79/100 PY [66][67][68][69][70][71][72][73][74] Possibly increased [75][76][77]; o IR 0.18-0.24/ 100 PY [76,77] No increase; IR 0.09/100 PY [77] Increased; IR 0.52-1.85/100 PY [74,[78][79][80] Risk of malignancy Increased [81][82][83]; by 10% overall versus general population [81] (lymphoma SIR 2.46, lung SIR 1.64, melanoma SIR 1.3) [81] Reduced for colorectal cancer (SIR 0.77) [81] and some hormone-dependent cancers No increase, except lymphoma [33,51] p Uncertain [84][85][86] Increased, SIR of 1.14 overall, including lymphoma [87,88] Table 1 Definition of obesity varied across studies [33] e Depending on the definition of hypertension [33] f Depending on the definition of CVD: includes coronary artery disease, myocardial infarction, congestive heart failure, stroke, peripheral vascular disease [33] g…”

Section: Methodsmentioning

confidence: 99%

“…2 ; Table 1 ). The increased risk of VTE in patients with moderate-to-severe AD or any AD was linked to an increased prevalence of comorbidities in these patients [ 76 , 77 ]. In hospitalised patients, patients with AD appeared to be at higher risk of VTE, DVT and PE than people without AD, with an AD diagnosis also being associated with a prolonged duration of VTE-related hospitalisation and greater inpatient mortality [ 75 ].…”

Section: Adverse Events Of Special Interest: Baricitinib Clinical Evi...mentioning

confidence: 99%

“…2 ; Table 1 ). Instead, results of this analysis suggested that patients with AA may have a lower risk that is lost when concomitant risk factors for VTE are considered [ 77 ].…”

Section: Adverse Events Of Special Interest: Baricitinib Clinical Evi...mentioning

confidence: 99%

“…requiring hospitalisation or intravenous antibiotics) reported in RCTs and their long-term extension studies, and RWE from patient registries in patients with RA (IR 1.5–7/100 PY) [ 47 ], SIs (defined as infections requiring hospitalisation in a general RA population) (IR 9.57/100 PY) [ 46 ] and a retrospective cohort analysis of patients all treated with DMARDs (77.4 to 87.7/100 PY) [ 48 ] j The odds of presenting to a US emergency department with a skin infection compared with those without AD [ 52 ]; risk is increased (extent not specified) [ 33 , 51 ] k OR of serious infection 1.2–2.2 for patients with AD versus controls [ 51 , 54 ]; HR of 1.17–1.68 for patients with mild to severe AD versus controls [ 53 ] l Data concerning the specific risk have not been identified m Based on findings of meta-analyses. Additionally, the risk ratio was 2.58 for pneumonia and 6.11 for tuberculosis [ 56 ] n Depending on severity of AD; higher in mild versus severe disease [ 61 ] o Patients with AD may be at higher risk of VTE (OR, 1.22), DVT (1.28) and PE (1.08) than people without AD [ 75 ], but some have found the risk to be only slightly, non-significantly, elevated [ 77 ] while others found the association only in patients with moderate-to-severe AD who have an IR of 0.31/100 PY [ 76 ] p RR 1.43; OR 1.83–3.72 depending on AD severity. No increased risk for other cancer types [ 33 ]…”

Section: Introductionmentioning

confidence: 99%

“…o Patients with AD may be at higher risk of VTE (OR, 1.22), DVT (1.28) and PE (1.08) than people without AD [ 75 ], but some have found the risk to be only slightly, non-significantly, elevated [ 77 ] while others found the association only in patients with moderate-to-severe AD who have an IR of 0.31/100 PY [ 76 ]…”

Section: Introductionmentioning

confidence: 99%

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A Review of Safety Outcomes from Clinical Trials of Baricitinib in Rheumatology, Dermatology and COVID-19

Bieber

Feist²,

Irvine

et al. 2022

Adv Ther

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Baricitinib is an oral, selective inhibitor of Janus kinase (JAK)1/JAK2 that transiently and reversibly inhibits many proinflammatory cytokines. This mechanism is a key mediator in a number of chronic inflammatory diseases; accordingly, baricitinib has been studied and approved for the treatment of several rheumatological and dermatological disorders, as well as COVID-19. This narrative review summarises and discusses the safety profile of baricitinib across these diseases, with special focus on adverse events of special interest (AESI) for JAK inhibitors, using integrated safety data sets of clinical trial data, and puts findings into context with the underlying risk in the respective disease populations, using supporting literature. We show that rates of infection with baricitinib generally reflected the inherent risk of the disease populations being treated, with serious infections and herpes zoster being more frequent in rheumatic diseases than in dermatological disorders, and herpes simplex being reported particularly in atopic dermatitis. Similarly, rates of major adverse cardiovascular events (MACE), venous thromboembolism (VTE) and malignancies were generally within or below the ranges reported for the respective disease populations, thereby reflecting the underlying risk; these events were therefore more frequent in patients with rheumatic diseases than in those with dermatological disorders, the latter of whom generally had low absolute risk. AESI were usually more common in patients with risk factors specific for each event. When a population similar to that of ORAL Surveillance was considered, the incidence rate of MACE with baricitinib was numerically lower than that reported with tofacitinib and similar to that of tumour necrosis factor inhibitors. No safety concerns were observed in hospitalised patients with COVID-19 who received baricitinib for up to 14 days. Identifying the patterns and likelihoods of AEs that occur during treatment in large groups of patients with different diseases can help the physician and patient better contextualise the benefit-to-risk ratio for the individual patient.

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Section: Methodsmentioning

confidence: 99%

Section: Adverse Events Of Special Interest: Baricitinib Clinical Evi...mentioning

confidence: 99%

“…2 ; Table 1 ). Instead, results of this analysis suggested that patients with AA may have a lower risk that is lost when concomitant risk factors for VTE are considered [ 77 ].…”

Section: Adverse Events Of Special Interest: Baricitinib Clinical Evi...mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

A Review of Safety Outcomes from Clinical Trials of Baricitinib in Rheumatology, Dermatology and COVID-19

Bieber

Feist²,

Irvine

et al. 2022

Adv Ther

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Venous Thromboembolism in Chronic Inflammatory Skin Diseases—The Need to Consider Bullous Pemphigoid—Reply

2022

Self Cite

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Association of Psoriasis With Incident Venous Thromboembolism and Peripheral Vascular Disease

Chen¹,

Lee

Huang

et al. 2022

JAMA Dermatol

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IMPORTANCE Psoriasis, venous thromboembolism (VTE), and peripheral vascular disease (PVD) share similar mechanisms involving chronic inflammation. However, the associations between psoriasis and VTE or PVD are unclear.OBJECTIVE To determine the association of psoriasis with incident VTE and PVD.DATA SOURCES MEDLINE, Embase, Cochrane Library, Web of Science, and Cumulative Index to Nursing and Allied Health Literature were systematically searched for relevant publications from their respective inception through May 21, 2021. No restrictions on language or geographic locations were imposed.STUDY SELECTION Two authors independently selected cohort studies that investigated the risk for incident VTE or PVD in patients with psoriasis. Any discrepancy was resolved through discussion with 2 senior authors until reaching consensus. Only 13 initially identified studies met the selection criteria for qualitative review, and only 9 of these for quantitative analysis. DATA EXTRACTION AND SYNTHESISThe Meta-analysis of Observational Studies in Epidemiology (MOOSE) reporting guideline was followed. Two authors independently extracted data and assessed the risk of bias of included studies by using the Newcastle-Ottawa Scale. Disagreements were resolved by discussion with 2 other authors. A random-effects model meta-analysis was conducted to calculate the pooled hazard ratios (HRs) with the corresponding confidence intervals for incident VTE and PVD. Subgroup analyses based on arthritis status, psoriasis severity, sex, and geographic location were also performed. MAIN OUTCOMES AND MEASURES Hazard ratios for incident VTE and PVD associated with psoriasis.RESULTS A total of 13 cohort studies with 12 435 982 participants were included. The meta-analysis demonstrated a significantly increased risk for incident VTE (pooled HR, 1.26; 95% CI, 1.08-1.48) and PVD (pooled HR, 1.27; 95% CI, 1.16-1.40) among patients with psoriasis. Subgroup analyses illustrated increased risk for incident VTE among participants with psoriatic arthritis (pooled HR, 1.24; 95% CI, 1.01-1.53), women (pooled HR, 1.89; 95% CI, 1.36-2.61), and those in Asia (pooled HR, 2.02; 95% CI, 1.42-2.88) and Europe (pooled HR, 1.28; 95% CI, 1.06-1.53).CONCLUSIONS AND RELEVANCE This systematic review and meta-analysis found an increased risk for incident VTE and PVD among patients with psoriatic disease. Typical presentations of VTE or PVD should not be overlooked in patients with psoriasis. Risk factors, such as obesity, physical inactivity, smoking, and varicose veins, should be identified and treated in patients with psoriasis, and medications like hormone-related therapies should be prescribed with caution.

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Incidence of Venous Thromboembolism in Patients With Dermatologist-Diagnosed Chronic Inflammatory Skin Diseases

Cited by 26 publications

References 61 publications

A Review of Safety Outcomes from Clinical Trials of Baricitinib in Rheumatology, Dermatology and COVID-19

A Review of Safety Outcomes from Clinical Trials of Baricitinib in Rheumatology, Dermatology and COVID-19

Venous Thromboembolism in Chronic Inflammatory Skin Diseases—The Need to Consider Bullous Pemphigoid—Reply

Association of Psoriasis With Incident Venous Thromboembolism and Peripheral Vascular Disease

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