Roy Fleischmann, MD: The Safety of JAK Inhibitors


Roy Fleishmann, MD, discusses his Rheumatology Winter Clinical Symposium presentation, “Beyond the package insert: JAK inhibitors (jakinibs): safety issues.”

Rheumatology Network interviewed Roy Fleishmann, MD, to discuss his Rheumatology Winter Clinical Symposium presentation, “Beyond the package insert: JAK inhibitors (jakinibs) – safety issues.” Fleischmann is Clinical Professor of Medicine at the University of Texas Southwestern Medical Center at Dallas and co-Medical Director of the Metroplex Clinical Research Center in Dallas.

Janus kinase (JAK) inhibitors are popular among patients with rheumatic diseases such as psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis, in part because they are oral therapies. While they have proven their efficacy, recently, safety has become an issue.

“With respect to safety, the whole issue has been confounded by the ORAL Surveillance study. We know that patients with active rheumatoid arthritis, which if untreated or inadequately treated, have a much higher incidence of serious infections, major adverse cardiovascular events (MACE), malignancies, and venous thromboembolism events (VTEs),” stated Fleishmann.

The ORAL Surveillance study, of which Fleischmann co-authored, analyzed tofacitinib 5 and 10 mg daily plus methotrexate versus tumor necrosis factor (TNF) inhibitors. He emphasizes that the TNF inhibitors had a much lower MACE incident rate in the study when compareid with other trials. Rates of malignancy and VTE were also relatively low, although rates were slightly numerically higher in the tofacitinib 5 mg group versus the TNF inhibitor. However, when identifying the numbers needed to harm for MACE, the safety profile remained strong.

ORAL Surveillance focused on a specific population of patients who were aged 50 years or older and had at least 1 cardiovascular risk factor. Even in this population, patients aged over 65 years with a history of smoking or risk of cardiovascular disease were most at risk of adverse events stemming from JAK inhibitor treatment.

View the entire interview below:

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