Sarilumab is now FDA approved to treat adults with polymyalgia rheumatica who have had an inadequate response to glucocorticoids or who cannot tolerate a glucocorticoid taper. This new indication is based on results from the multicenter, phase 3 SAPHYR trial.
Adami et al. examined the fracture risk associated with glucocorticoid treatment in women with inflammatory rheumatic musculoskeletal diseases, finding that low-dose glucocorticoid use may result in significant bone mineral density loss in patients who are not on anti-osteoporotic drugs.
The ACR recently released its first guideline focused on vaccination in adult and pediatric patients with rheumatic and musculoskeletal diseases.1 The guideline recommends modifications to certain vaccine and medication schedules to increase immunogenicity and ensure patient safety, while encouraging providers not to miss vaccination opportunities. The Need Patients with rheumatic conditions who are on immunosuppressive…
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…
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.
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.
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.
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.
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.
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…