Background & Objectives The ORAL Surveillance trial (NCT02092467), a postauthorization safety study of tofacitinib in patients with rheumatoid arthritis (RA) aged 50 years or older with at least one additional cardiovascular risk factor, found a dose-dependent increase in venous thromboembolism (VTE) and pulmonary embolism (PE) events when patients were treated with tofacitinib vs. a tumor…
3 AC&R Study Summaries: Prescribing Patterns, PMR & Glucocorticoids, & Infection Screening
A Shift in Prescribing Patterns Safety issues prompt discontinuation of tofacitinib By Stephanie Song, MD, & Joshua F. Baker, MD, MSCE Why was this study done? The ORAL Surveillance study highlighted risks of cardiac events, thromboembolism (VTE) and malignancy associated with use of Janus kinase inhibitors (JAKi). We sought to determine the impact of safety…
A Novel Study Compared the Effectiveness of Adalimumab with Tofacitinib in RA
Your patient with rheumatoid arthritis (RA) isn’t responding well enough to methotrexate, and you both agree it’s time to consider a biologic or targeted synthetic disease-modifying anti-rheumatic drug (DMARD). But which one should you choose? In a treat-to-target era, we’re fortunate to have a variety of RA therapies at our disposal. Clinical practice guidelines from…
Cardiovascular Safety with RA Treatments
Research by Chicre et al. found that Janus kinase inhibitors may significantly increase the risk of major adverse cardiac events and all-cause death in patients with rheumatoid arthritis (RA) when compared with other RA treatments. This study highlights the need for more comparative safety studies.
Conservation of Drugs: The Impact of Acute Immunomodulator Prescribing for COVID-19 on Rheumatology Patients
In its COVID-19 treatment guidelines, the National Institutes of Health (NIH) lists several drugs commonly prescribed for patients with rheumatic conditions as potential therapies in those who are hospitalized for COVID-19 and require high-flow oxygen, noninvasive ventilation, intermittent ventilation (IMV) or extracorporeal membrane oxygenation (ECMO), as of Aug. 25, 2021, and current as this is…
Tofacitinib Yields Rapid & Sustained Improvement in JIA
NEW YORK (Reuters Health)—Tofacitinib significantly reduces the number of flares in children with polyarticular course juvenile idiopathic arthritis (JIA), according to the first phase-3 clinical trial to assess the efficacy of a Janus kinase (JAK) inhibitor in JIA. JIA is a heterogeneous group of chronic conditions with no known cause that develop before age 16…
FDA Discussed 2021 Drug Warnings & Approvals at ACR Annual Meeting
ACR Convergence 2021—The recent Boxed Warning requirement applied to three Janus kinase (JAK) inhibitors, cautioning doctors and patients about several major risks in patients with rheumatoid arthritis, came only after rigorous data collection and careful consideration of the risks and the benefits, U.S. Food & Drug Administration (FDA) officials said in November at ACR Convergence…
FDA Requires New Boxed Warnings on JAK Inhibitors, Places Restrictions on Use
On Sept. 1, the U.S. Food & Drug Administration (FDA) announced that it is requiring revisions to the Boxed Warning for the Janus kinase (JAK) inhibitors Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib) and Rinvoq (upadacitinib) to include information about the risks of serious heart-related events, cancer, blood clots and death.1 Recommendations for healthcare professionals will include…
Janus Kinase Inhibitors Promising for Difficult-to-Treat RA
In a study, Janus kinase inhibitors proved effective for patients with difficult-to-treat rheumatoid arthritis (RA).
Tofacitinib Promising for COVID-19 Pneumonia
(Reuters)—Pfizer Inc. said on June 16 its oral rheumatoid arthritis (RA) drug Xeljanz (tofacitinib) reduced death or respiratory failure in hospitalized COVID-19 patients with pneumonia in Brazil, meeting the study’s main goal. Results of the study, which tested the drug in 289 hospitalized adult patients with the respiratory illness caused by the coronavirus, were published…
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