Cardiovascular Risk Management in Patients Treated With Janus Kinase Inhibitors

Shah, Jill T.; Shah, Keya T.; Femia, Alisa N.; Lo Sicco, Kristen I.; Merola, Joseph F.; Weber, Brittany; Garshick, Michael S.

doi:10.1097/fjc.0000000000001470

Cited by 2 publications

(2 citation statements)

References 55 publications

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“…Therefore, the results of our study may not be translatable to patients with dermatologic conditions at higher cardiovascular risk. An individualized approach to cardiovascular risk management in patients who may benefit from JAK inhibitor therapy is likely appropriate …”

Section: Discussionmentioning

confidence: 99%

Cardiovascular and Venous Thromboembolic Risk With JAK Inhibitors in Immune-Mediated Inflammatory Skin Diseases

Ingrassia,

Maqsood,

Gelfand

et al. 2024

JAMA Dermatol

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ImportanceJanus kinase (JAK) inhibitors are an effective treatment option for patients with certain skin-related conditions, such as atopic dermatitis, alopecia areata, and vitiligo, but there is a current US Food and Drug Administration (FDA) boxed warning label for oral and topical JAK inhibitors regarding increased risk of major adverse cardiovascular events (MACE), venous thromboembolism (VTE), serious infections, malignant neoplasm, and death. However, this boxed warning was precipitated by results of the Oral Rheumatoid Arthritis Trial (ORAL) Surveillance study, which only included patients with rheumatoid arthritis, and the same association may not be observed in dermatologic conditions.ObjectiveTo determine the risk of all-cause mortality, MACE, and VTE with JAK inhibitors in patients with dermatologic conditions.Data SourcesPubMed and ClinicalTrials.gov were searched from database inception to April 1, 2023.Study SelectionThis review included phase 3 randomized clinical trials with a placebo/active comparator group of JAK inhibitors used for a dermatologic indication with FDA approval or pending approval or with European Union or Japanese approval. Studies without a comparison group, case reports, observational studies, and review articles were excluded.Data Extraction and SynthesisThis study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Adverse events using odds ratios (ORs) and 95% CIs were calculated using a random-effects model and the DerSimonian-Laird method. Studies were screened, data abstracted, and quality assessed by 2 independent authors. The protocol was prospectively registered with PROSPERO.Main Outcomes and MeasuresPrimary outcomes were a composite of adjudicated MACE and all-cause mortality, and VTE.ResultsThe analysis included 35 randomized clinical trials with 20 651 patients (mean [SD] age, 38.5 [10.1] years; male, 54%) and a mean (SD) follow-up time of 4.9 (2.68) months. Findings did not show a significant difference between JAK inhibitors and placebo/active comparator in composite MACE and all-cause mortality (OR, 0.83; 95% CI, 0.44-1.57) or VTE (OR, 0.52; 95% CI, 0.26-1.04).Conclusions and RelevanceIn this systematic review and meta-analysis, use of JAK inhibitors was not associated with increased risk of all-cause mortality, MACE, and VTE compared to the placebo/active comparator groups. Additional trials with long-term follow-up are needed to better understand the safety risks of JAK inhibitors used for dermatologic indications.

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Section: Discussionmentioning

confidence: 99%

Cardiovascular and Venous Thromboembolic Risk With JAK Inhibitors in Immune-Mediated Inflammatory Skin Diseases

Ingrassia,

Maqsood,

Gelfand

et al. 2024

JAMA Dermatol

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“…14,15 Huck et al 16 from Boston, MA, review the evolving data regarding targeting pharmacotherapies for inflammatory and cardiorenal endpoints in kidney disease. Finally, Shah et al 17 from New York, NY, address cardiovascular risk management in patients treated with Janus kinase inhibitors, known to promote arterial and venous thrombotic events.…”

mentioning

confidence: 99%

Inflammation and Heart Diseases: Immunology, Cardiology, and Rheumatology

Abbate,

Weber,

Garschick

et al. 2024

Journal of Cardiovascular Pharmacology

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Disclosures: A. Abbate has received research support or consultant fees from CardiolRx, Implicit Biosciences, Kiniksa, Novo Nordisk, and Olatec; B. Weber reports scientific advisory board fees from Novo Nordisk, Kiniksa Pharmaceuticals, and Horizon Therapeutic. M. Garschick reports consultant fees for Kiniska, Agepha, BMS, and Horizon Therapeutics. L. Adamo has received consultant fees from Kiniksa and is co-founder of i-Cordis, LLC. C. Beavers has nothing to disclose.

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Cardiovascular Risk Management in Patients Treated With Janus Kinase Inhibitors

Cited by 2 publications

References 55 publications

Cardiovascular and Venous Thromboembolic Risk With JAK Inhibitors in Immune-Mediated Inflammatory Skin Diseases

Cardiovascular and Venous Thromboembolic Risk With JAK Inhibitors in Immune-Mediated Inflammatory Skin Diseases

Inflammation and Heart Diseases: Immunology, Cardiology, and Rheumatology

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