MHRA issued alert to discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur. Prescribers are reminded to use caution if using baricitinib in patients with risk factors for deep vein thrombosis or pulmonary embolism in addition to rheumatoid arthritis.
Baricitinib (Olumiant) is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to, or who are intolerant, to one or more disease-modifying anti-rheumatic drugs.
In April 2017, clinical trial findings showed an imbalance in cases of deep vein thrombosis and pulmonary embolism with baricitinib treatment compared with placebo. However, at the time a causal link could not be fully established due to the presence of confounding factors. Based on the data, a warning was added to recommend that baricitinib be used with caution in patients with risk factors for deep vein thrombosis and pulmonary embolism and that if patients experience signs of venous thromboembolism, treatment should be temporarily interrupted and patients should be evaluated promptly.
Following findings of an increased risk of pulmonary embolism in an ongoing study with another JAK inhibitor, tofacitinib, a recent European cumulative review reassessed the evidence for risk with baricitinib. The advice has now been updated to recommend discontinuation of baricitinib if clinical signs of venous thromboembolism occur.
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