Safety Analysis of Baricitinib in Long-Term Treatment of Rheumatoid Arthritis
Janus kinase inhibitors are relatively new and very promising drugs, but their novelty also raises the question: Are they really safe? A brand-new analysis provides the answer by examining a cohort of patients treated for the longest duration to date.
Introduction
Baricitinib is an oral inhibitor of Janus kinases JAK1 and JAK2, approved for the treatment of rheumatoid arthritis in adults. Although its safety has long been considered satisfactory without raising significant concerns, a recently published study evaluated its safety in a cohort of patients treated for over 8 years. When converting the dataset to patient-years, which represent the years of treatment for individual patients, the result is a remarkable figure of 13,148 patient-years.
Monitored Parameters
This study monitored all adverse events that occurred in patients during the observation period, with a special focus on deep vein thrombosis, pulmonary embolism, serious infections, cardiovascular events, and malignancies based on previous observations. Among infections, particular interest was paid to tuberculosis, herpes zoster, and others. The main monitored parameter was the increase in the incidence of these conditions with longer exposure to baricitinib. The authors also aimed to address whether prolonged treatment increased mortality. Satisfactory answers were provided to all these questions.
Results
The key safety parameters in this analysis showed similar safety to previous studies on baricitinib. Serious infections had an incidence comparable to placebo, regardless of age. When divided into age categories, it was merely observed that patients older than 65 had a generally higher risk of infections than younger patients. The risk of malignancy and death, when adjusted for age, was stable and did not increase with longer use of baricitinib. The adjustment for age was not conducted for non-melanoma skin cancers, but their incidence remained stable as well. The same situation applied to herpes zoster, cardiovascular events, and thromboembolic disease.
Conclusion
This analysis demonstrated that long-term use of baricitinib does not increase the risks of routinely monitored adverse events. Therefore, there is no reason to doubt the safety profile that has been long reported for this substance.
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Source: Genovese M. C., Smolen J. S., Takeuchi T. et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 8.4 years: an updated integrated safety analysis. European League Against Rheumatism (EULAR), 2020 Jun.
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