For a study, it was determined that in the European Union and Japan, baricitinib, a selective Janus kinase 1/Janus kinase 2 inhibitors, was approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adults for systemic therapy. Researchers wanted to assess the safety of baricitinib 2 mg in an atopic dermatitis clinical trial. Two databases were created to summarize six double-blind, randomized, placebo-controlled experiments and two long-term extension studies. About six trials of 16-week with baricitinib 2 mg were used to compare it to a placebo. Patients who received baricitinib 2 mg at any point during the eight investigations were included in the All-bari-2-mg-AD study.
In all, 1,598 patients were given once-daily baricitinib 2 mg for a total of 1434.2 patient-years (median 330 days/maximum 2.4 years). Baricitinib 2 mg had a greater rate of treatment-emergent adverse events (57.9%) than placebo (51.6%). Major adverse events, serious infections, and opportunistic infections were uncommon and comparable between baricitinib 2 mg and placebo. During the placebo-controlled period, there were no malignancies, gastrointestinal perforations, or significant adverse cardiovascular events with baricitinib 2 mg. Herpes simplex (cluster) was more common with baricitinib 2 mg (3.8%) compared to placebo (2.8%); rates were reduced with longer 2 mg treatment. There were five non-melanoma skin cancers, two significant adverse cardiovascular events, one peripheral venous thrombosis, one arterial thrombosis, and no pulmonary embolisms, deep vein thrombosis, or fatalities in the All-bari-2-mg-AD study.
This comprehensive study of individuals with moderate-to-severe atopic dermatitis verifies the recognized safety profile of baricitinib 2 mg. Longer treatment exposure was necessary to assess the risks of malignancies and significant adverse cardiovascular events.