First described in 1888, polymyalgia rheumatica (PMR) is a chronic inflammatory condition that almost exclusively affects individuals older than 50.1 Until this week, no therapies for PMR had been approved by the U.S. Food & Drug Administration (FDA).2 Tuesday, Sanofi announced sarilumab (Kevzara) has been approved by the U.S. Food & Drug Administration for the…
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.
Glucocorticoids May Decrease White Matter Integrity & Change Gray Matter Volume
Van der Meulen et al. found the use of both systemic and inhaled glucocorticoids is associated with changes in several brain imaging parameters, including decreased white matter integrity and gray matter volume. Study patients also reported more depressive symptoms and tiredness than controls.
FDA Approves Abaloparatide to Treat Men with Osteoporosis & a High Risk of Fracture
In late December, the FDA approved subcutaneous abaloparatide for the treatment of men with osteoporosis at a high risk of fracture. This approval is based on a placebo-controlled study that showed abaloparatide led to significant increases in bone mineral density of the lumbar spine, total hip and femoral neck. Abaloparatide was approved in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
FDA Revokes Emergency Use Authorization for Evusheld
The Food & Drug Administration announced Jan. 26 that tixagevimab/cilgavimab (Evusheld) is no longer authorized for use in the U.S. The decision was based on new data suggesting that the treatment is unlikely to be active against the most common current SARS-CoV-2 variants.
First Biosimilar to Adalimumab (Humira) Enters the U.S. Market After Years of Legal Battles
After years of legal disputes between drug makers, adalimumab-atto (Amjevita) biosimilar to adalimumab (Humira) is now available in the U.S. to treat rheumatoid arthritis and other diseases. Adalimumab-atto is the first of several biosimilars to adalimumab expected to become available in the U.S. in 2023.
FDA Officials Speak Out: New Approvals & Safety Concerns Discussed
PHILADELPHIA—Officials from the U.S. Food & Drug Administration discussed recent drug approvals and drug safety issues at ACR Convergence in November in a session that captured the flurry of activity in the rheumatology sphere at the agency over the past year. Sabiha Khan, MD, clinical reviewer in the Division of Rheumatology and Transplant Medicine at…
Mitigating Drug Shortages: FDA Officials Say Communication Is Crucial
PHILADELPHIA—The most vital component of avoiding drug shortages is early communication, officials from the U.S. Food & Drug Administration (FDA) said in a session at ACR Convergence 2022 in November. “Early notification is key in order to prevent and mitigate shortages,” said Hyun Son, PharmD, a member of the Drug Shortage Staff with the FDA…
Insights into Methotrexate Toxicity in Elderly Patients with Rheumatic Disease
Data from a small study show that severe methotrexate toxicity in patients who are 70 years of age and older and have rheumatic disease may be associated with poor renal function and the use of diuretic treatments.
Zoledronic Acid vs. Oral Bisphosphonates: Osteoporosis Treatments & the Risk of Developing Osteonecrosis of the Jaw
A study from Amigues et al. found that bisphosphonate-associated osteonecrosis of the jaw is rare in patients with osteoporosis and may occur more often in patients treated with injectable zoledronic acid than in those treated with the oral bisphosphonates.
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