Safety of Baricitinib in East Asian Patients With Moderate to Severe Active Rheumatoid Arthritis: An Integrated Analysis From Clinical Trials
Post-hoc analyses of five completed phase II and III trials and an ongoing LTE suggested that BARI QD is well tolerated in East Asian patients with moderate-to-severe RA, with a similar safety and tolerability profile to the overall population.
The majority of clinical evidence for RA treatments has been obtained from a predominantly Caucasian population, which may not be relevant to East Asian patients. In this post-hoc safety analysis, 740 Japanese, Taiwanese, Korean and Chinese patients were included with 1294 PY of total BARI exposure. Exposure adjusted incidence rates of adverse events were calculated as the number of patients with an event per 100 PY of overall exposure time.
AEs caused 109 patients to discontinue BARI treatment (EAIR: 8.4). Serious AEs were reported by 125 patients (EAIR: 9.7) of which serious infections were the most common. Infections of special interest included TB and HZ. There were 3 cases of TB and a numerically higher IR for HZ was observed in East Asian patients than the overall population. Recent studies have shown the incidence of VTE has increased in Asia, in this analysis there were no cases of PE however, DVT was reported in 4 patients (EAIR: 0.3). Laboratory abnormalities included elevated ALT levels and significant increases from baseline in both LDL and HDL with BARI 4 mg. The authors concluded the integrated data showed BARI QD is well tolerated in East Asian patients and was generally consistent with the safety profile of the overall population. They also acknowledge the limitations related to the post-hoc analysis and the relatively low number of patients.