LAUSR

OBJECTIVE Preliminary data brought licensing authorities to alert clinicians of an increased venous thrombotic risk associated to the use of 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 database until October 2021. Risk of bias was assessed according to Cochrane criteria. The beta-binomial modelwas applied to calculate pooled OR and corresponding 95% CI. PROSPERO registration number is CRD42022324143. RESULTS We have included 1 phase I, 21 phase II, 3 phase II-III and 36 phase III RCTs for a total of 19443 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. IMIDs 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 sub-analyses for each investigated IMIDs, drug and dosage. CONCLUSION JAKi do not increase thromboembolic risk compared with placebo in IMIDs patients enrolled in selected RCTs.