Tofacitinib Safety Comparable With Biologics

The following article features coverage from ACR 2017 in San Diego, California. Click here to read more of Rheumatology Advisor‘s conference coverage.

SAN DIEGO — According to the results of research presented at the American College of Rheumatology 2017 Annual Meeting, taking place November 3-8 in San Diego, California, the real-world rates of most adverse events in patients with psoriatic arthritis receiving several biologics may be comparable with those reported in phase 3 studies of tofacitinib — with the exception of herpes zoster infection, shown to be more common in patients treated with tofacitinib.

Researchers compared the rates of adverse events experienced by adult patients with psoriatic arthritis taking tofacitinib as part of phase 3 studies (5 mg tofacitinib: n=238; 10 mg: n=236) with the real-world rates in patients with psoriatic arthritis treated with systemic agents for their condition (n=5799). The phase 3 exclusion criteria were applied to the real-world comparators.

Serious infection events requiring parenteral antibiotics in an outpatient or emergency setting or hospitalization were similar in the tofacitinib groups and comparators. In addition, malignancies and major adverse cardiovascular events were comparable in all groups. The rates of herpes zoster infections were higher in the tofacitinib vs comparator group (incidence rate: 1.96 [5 mg] vs 2.66 [10 mg] vs 1.26 [comparison]).

A greater percentage of patients treated with tofacitinib had previous exposure to corticosteroids compared with the control group (15.7% for 5 mg tofacitinib; 28.2% for 10 mg tofacitinib;  11.9% for controls), disease-modifying antirheumatic drugs (100% vs 46.6%), and tumor necrosis factor inhibitors (48.1%, 55.9%, and 36.6%, respectively).

The researchers concluded that rates of adverse events “reported in tofacitinib [psoriatic arthritis] phase 3 studies were generally comparable to those in a general [psoriatic arthritis] population comprising [patients] receiving a range of biologic agents, except [herpes zoster], which was higher for tofacitinib-treated [patients] but similar to the incidence observed with tofacitinib treatment in other indications.”

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Reference

Curtis JR, Yun H, FitzGerald O, et al. Comparing tofacitinib safety profile in patients with psoriatic arthritis in clinical studies with real-world data. Presented at: 2017 ACR/ARHP Annual Meeting; November 3-8, 2017; San Diego, California. Poster 617.