medwireNews: A pooled analysis of data from the SELECT trials suggests that the selective Janus kinase (JAK)1 inhibitor upadacitinib is not associated with an increased risk for major adverse cardiovascular events (MACE) or venous thromboembolism (VTE) among patients with rheumatoid arthritis (RA).
Ernest Choy (Cardiff University, UK) and co-researchers evaluated MACE and VTE risk from five phase III randomized controlled trials – SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-MONOTHERAPY, and SELECT-BEYOND – involving different populations of RA patients, background therapies, and comparator treatments. The duration of the controlled period ranged from 12 weeks in SELECT-NEXT to 48 weeks in SELECT-EARLY and SELECT-COMPARE.
Click here for a guide to the trials of JAK inhibitors in RA, including the SELECT trials
Speaking to delegates at the 2019 ACR/ARP Annual Meeting in Atlanta, Georgia, USA, Choy reported that rates of any adjudicated MACE were comparable among patients treated with upadacitinib 15 mg or 30 mg once daily, placebo, methotrexate, or adalimumab. Event rates per 100 patient–years were 0.6, 1.0, 1.2, 0.5, and 0.4, respectively, and the duration of follow-up ranged from 256.8 patient–years for the pooled placebo group to 2655.1 patient–years for the pooled upadacitinib 30 mg/day group.
Similarly, rates of any adjudicated VTE were not significantly different across the treatment arms, and ranged from 0.3 per 100 patient–years for upadacitinib 30 mg/day to 1.1 per 100 patient–years for adalimumab.
Choy noted that these rates of MACE and VTE were “consistent with the background rates [in] the RA population,” and that all patients who experienced MACE or VTE had at least one risk factor for the event at baseline. Such risk factors included diabetes, obesity, and a history of cardiovascular disease for MACE, and obesity, hypertension, and prior thromboembolic events for VTE.
The researchers also found no association between low-density lipoprotein cholesterol levels and MACE, nor between platelet counts and VTE, among upadacitinib-treated patients.
Together, these findings indicate that upadacitinib poses “no apparent increase” in the risk for MACE or VTE over the time period studied, concluded Choy.
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Arthritis Rheumatol 2019; 71 (suppl 10)
ACR/ARP 2019; Atlanta, Georgia, USA: 8–13 November