Arthritis Drug Does Not Increase Risk of Blood Clots

Tofacitinib use is not associated with an increased risk for deep vein thrombosis (DVT) or pulmonary embolism (PE) in patients with rheumatoid arthritis (RA), psoriasis, psoriatic arthritis (PsA), or ulcerative colitis (UC), according to a new study.

The study’s findings were presented at the ACR/ARHP Annual Meeting, which is taking place from November 3 to 8, 2017, in San Diego, California.
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To better assess VTE risk with tofacitinib, the researchers reviewed previous studies of tofacitinib as a monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs in patients with RA, psoriasis, PSA, or UC. Studies were categorized as placebo-controlled or dose-comparison.

MedDRA embolic and thrombotic SMQ preferred terms were used to determine first DVT and PE events. Incidence rates (IRs) were calculated based on single events that occurred during treatment, within 28 days of the last dose, or up to the cohort cut-off date.

Results indicated that, in the placebo-controlled cohort, DVT and PE had occurred in 1 patient with RA and in 1 patient with UC, both of whom were on placebo. However, no patients taking tofacitinib had experienced DVT or PE events. In the dose-comparison cohort, 2 DVT events were reported among patients with RA taking tofacitinib, and 1 DVT event in a patient with PsA taking tofacitinib. IRs were 0.1 for both RA patients, and 0.5 for the PsA patient.

“Analysis of DVT and PE across randomized clinical studies for RA, [psoriasis], PsA, and UC showed no evidence of an increased risk of events with tofacitinib,” the researchers concluded.

—Christina Vogt

Reference:

Mease PJ, Kremer J, Cohen S, et al. Incidence of thromboembolic events in the tofacitinib rheumatoid arthritis, psoriasis, psoriatic arthritis and ulcerative colitis development programs. Paper presented at: ACR/ARHP Annual Meeting; November 3-8, 2017; San Diego, CA. http://acrabstracts.org/abstract/incidence-of-thromboembolic-events-in-the-tofacitinib-rheumatoid-arthritis-psoriasis-psoriatic-arthritis-and-ulcerative-colitis-development-programs/.