On Dec. 8, the U.S. Food & Drug Administration (FDA) issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). The product…
Therapeutics for COVID-19: An update from ACR Convergence 2021
ACR CONVERGENCE 2021—Rheumatology patients who test positive for COVID-19 would benefit from early use of monoclonal antibodies, said Luis Ostrosky-Zeichner, MD, chief of the Division of Infectious Diseases, McGovern Medical School, University of Texas Health Science Center (UTHealth), Houston, in a session about effective treatment options for COVID-19. Acknowledging that the SARS-CoV-2 virus has already…
Does Switching from IV to Subcutaneous Tocilizumab Affect RA Disease Flare?
Researcher identified multiple factors for flare, including non-use of methotrexate, in patients with rheumatoid arthritis who had switched from intravenous (IV) tocilizumab to subcutaneous tocilizumab.
Pegloticase Proves Promising for Gout in Patients Who Have Undergone Kidney Transplant
Patients who have undergone a kidney transplant and have high levels of serum uric acid symptomatic gout may benefit from treatment with pegloticase, according to a recent study.
The Great Debate: Belimumab vs. Voclosporin in Lupus Nephritis
ACR Convergence 2021—The Great Debate at the meeting sparked a thoughtful discussion on the future of lupus nephritis treatment strategies, with experts saying clinicians should be open to new ways of approaching patient care. In the past year, approvals of the monoclonal antibody belimumab and the calcineurin inhibitor voclosporin for use in lupus nephritis (when…
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 Approves First Interchangeable Biosimilar to Adalimumab, Plus a Combination Drug Approved
Cyltezo (adalimumab-adbm) may be interchanged for Humira (adalimumab) for all indications, according to an October decison by the FDA. The FDA has also approved a new combination of celecoxib and tramadol for pain management.
Considerations for Prescribing Avacopan for ANCA-Associated Vasculitis
In early October, the FDA approved avacopan to treat anti-neutrophil cytoplasmic antibody associated vasculitis. Here are insights into the treatment’s risks and considerations.
TNF Inhibitors & Pregnancy: How Well Does the Treatment Guidance Work?
Ghalandari et al. sought to validate the guidance outlined by EULAR for the use of anti-rheumatic drugs during pregnancy, finding that following its guidance for tumor necrosis factor inhibitors led to no or low concentrations of these agents in cord blood.
FDA Approves Cyltezo, an Interchangeable Biosimilar to Humira
On Oct. 15, the U.S. Food & Drug Administration (FDA) approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to and interchangeable with (i.e, may be substituted for) its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar…
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