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Are Risks for Mortality, MACE, VTE Increased With JAK Inhibitor Use in Skin Conditions?

No increased risk observed for all-cause mortality, MACE, VTE versus placebo/active comparator in dermatologic conditions

By Dermsquared Editorial Team | November 01, 2023

WEDNESDAY, Nov. 1, 2023 -- For patients with dermatologic conditions, Janus kinase (JAK) inhibitors are not associated with an increased risk for all-cause mortality, major adverse cardiovascular events (MACE), or venous thromboembolism (VTE) compared with placebo/active comparator, according to a systematic review and meta-analysis published online Nov. 1 in JAMA Dermatology.

Noting that there is a current U.S. Food and Drug Administration boxed warning label for oral and topical JAK inhibitors regarding increased risk for MACE, VTE, serious infections, malignant neoplasm, and death, Jenne P. Ingrassia, from NYU Langone Health in New York, and colleagues examined the risk for all-cause mortality, MACE, and VTE with JAK inhibitors in patients with dermatologic conditions in a review of phase 3 randomized clinical trials with a placebo/active comparator group. A total of 35 randomized clinical trials, with 20,651 patients, were included, with a mean follow-up of 4.9 months.

The researchers found that for composite MACE and all-cause mortality or VTE, there was no significant difference between JAK inhibitors and placebo/active comparator.

"We did not find an elevated risk of adjudicated composite all-cause mortality and MACE or VTE in patients treated with short-term oral or topical JAK inhibitor therapy for immune-mediated inflammatory diseases of the skin," the authors write. "It remains unclear if the cardiovascular risks of JAK inhibitors are primarily due to patient-level cardiovascular risk factors or are drug mediated."

Several authors disclosed ties to the pharmaceutical industry; one author is a patent holder of resiquimod for the treatment of cutaneous T-cell lymphoma.


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