Venous and arterial thromboembolic risk of Janus kinase inhibitors: a systematic review with meta-analysis.

Autor: Campanaro F; Rheumatology Unit, Internal Medicine Department, ASST Sette Laghi, Ospedale Di Circolo-Fondazione Macchi, Varese, Italy., Zaffaroni A; School of Medicine, Department of Medicine and Surgery, University of Insubria, Varese and Como, Italy., Cacioppo E; School of Medicine, Department of Medicine and Surgery, University of Insubria, Varese and Como, Italy., Cappelli A; Rheumatology Unit, Internal Medicine Department, ASST Sette Laghi, Ospedale Di Circolo-Fondazione Macchi, Varese, Italy., Bertù L; Research Center on Thromboembolic Diseases and Antithrombotic Therapies, Department of Medicine and Surgery, University of Insubria, Varese and Como, Italy., Donadini MP; Research Center on Thromboembolic Diseases and Antithrombotic Therapies, Department of Medicine and Surgery, University of Insubria, Varese and Como, Italy.; Medicina d'Urgenza e Centro Trombosi ed Emostasi, Dipartimento Di Area Emergenza e Urgenza, Ospedale di Circolo-Fondazione Macchi, ASST Sette Laghi, Varese, Italy., Squizzato A; Research Center on Thromboembolic Diseases and Antithrombotic Therapies, Department of Medicine and Surgery, University of Insubria, Varese and Como, Italy.; Dipartimento Di Medicina, Internal Medicine Unit, 'Sant'Anna' Hospital, ASST Lariana, Como, Italy., Batticciotto A; Rheumatology Unit, Internal Medicine Department, ASST Sette Laghi, Ospedale Di Circolo-Fondazione Macchi, Varese, Italy.
Jazyk: angličtina
Zdroj: Rheumatology (Oxford, England) [Rheumatology (Oxford)] 2023 Oct 03; Vol. 62 (10), pp. 3245-3255.
DOI: 10.1093/rheumatology/kead211
Abstrakt: Objective: Preliminary data led licencing authorities to alert clinicians of an increased venous thrombotic risk associated to the use of Janus kinase (JAK) inhibitors (JAKi). We performed a systematic review to estimate the risk of venous and arterial thrombosis associated to JAKi for the treatment of immune-mediated inflammatory diseases (IMIDs).
Methods: Randomized controlled trials (RCTs) on JAKi in patients with IMIDs were identified by the MEDLINE and EMBASE databases until October 2021. Risk of bias was assessed according to Cochrane criteria. The beta-binomial model was applied to calculate pooled odds ratio (OR) and corresponding 95% CI. The PROSPERO registration number is CRD42022324143.
Results: We have included one phase I, 21 phase II, three phase II-III and 36 phase III RCTs for a total of 19 443 patients in the JAKi group and 6354 in the control group. Thirty-one (unweighted rate 0.16%; 95% CI: 0.10, 0.21) events were reported in the JAKi group and 20 (unweighted rate 0.22%; 95% CI: 0.12, 0.32) in the control group in a mean follow-up of 16.8 weeks. IMID patients treated with JAKi did not have an increased thromboembolic risk compared with those treated with placebo (OR 0.82; 95% CI: 0.43, 1.56). No statistically different results were seen in subanalyses for each investigated IMID, drug and dosage.
Conclusion: JAKi do not increase thromboembolic risk compared with placebo in IMID patients enrolled in selected RCTs.
(© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Databáze: MEDLINE