Results of a pooled data analysis published in Arthritis & Rheumatology suggest no association between baricitinib use and cardiovascular events in patients with rheumatoid arthritis (RA).
Investigators pooled data from 9 RA clinical trials to examine the frequency of certain adverse events associated with baricitinib treatment for RA. Subsequent analyses were performed for 3 sets of studies, including a placebo comparison set, comprising data from 6 studies in which patients could be randomly assigned to placebo or baricitinib 4 mg; a randomized dose comparison set, comprising data from 4 studies in which patients could be randomly assigned to placebo, 2 mg, or 4 mg baricitinib; and an “All-bari-RA” set, or all 9 studies examining baricitinib at any dose. The randomized dose comparison set also included data from a long-term extension study, which provided data on up to 336 weeks of baricitinib exposure. Major adverse cardiovascular events (MACE), including myocardial infarction, stroke, cardiovascular death, and other cardiovascular events were adjudicated by an independent external clinical end point committee.
In the pooled data set, 3492 patients received baricitinib for 7860 patient-years of exposure. In the All-bari-RA set, mean age at baseline was 53 years, 79% were women, and time since RA diagnosis was 8 years. A total of 78% of patients had ≥1 year and 63% had ≥2 years of baricitinib exposure, with a maximum exposure value of 6.1 years. The incidence rates (IRs) for adjudicated MACE were comparable between placebo (0.5 per 100 patient-years; 95% CI, 0.1-2.0) and baricitinib 4 mg (0.8 per 100 patient-years; 95% CI, 0.2-2.2). Additionally, no clear dose response was observed between baricitinib and MACE likelihood during the extended observation period.
Deep vein thrombosis/pulmonary embolism was reported in 0 of 1070 patients treated with placebo and 6 of 997 (0.6%) patients treated with baricitinib 4 mg during the placebo-controlled period. Of these adverse events, 2 were serious and 1 occurred after discontinuation of the study drug. In the randomized dose comparison set, IRs for event types were comparable between the 2 mg (0.5 per 100 patient-years) and 4 mg (0.6 per 100 patient-years) dosage levels. In the All-bari-RA analysis set, deep vein thrombosis/pulmonary embolism occurred at an IR of 0.5 per 100 patient-years.
Data from RA clinical trials suggest no association between baricitinib and adverse cardiovascular or venous thromboembolic events. During long-term evaluation, incidence rates for adverse events remained consistent and similar between doses.
Taylor PC, Weinblatt ME, Burmester GR, et al. Cardiovascular safety during treatment with baricitinib in rheumatoid arthritis [published online January 21, 2019]. Arthritis Rheumatol. doi: 10.1002/art.40841