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.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer and editor. She is also a pharmacist at New York Presbyterian Hospital–Lower Manhattan campus. She has been a past guest lecturer at Touro College of Pharmacy in New York City for the Medical Writing elective. Dr Kaufman is a member of the New York City Society of Health-Systems Pharmacy, the New York State Council of Health-System Pharmacists, the Academy of Managed Care Pharmacy (AMCP)—Northeast Region Affiliate Chapter, the American Society of Consultant Pharmacists and the Empire State-Metropolitan NY Chapter of the American Medical Writers Association. She received her BS in Pharmacy from the University of Rhode Island (URI) College of Pharmacy and her Doctor of Pharmacy degree from Massachusetts College of Pharmacy and Allied Health Sciences in Boston. She also completed a Drug Information Fellowship at the URI Drug Information Center/Roger Williams Medical Center in Providence, R.I. Dr Kaufman is a registered pharmacist and is a Board-Certified Geriatric Pharmacist.
Articles by Michele B. Kaufman, PharmD, BCGP
Glucocorticoid Use May Result in Loss of Bone Mineral Density
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.
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.
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.
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.
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.
Patients on Dialysis Taking Denosumab May Be at Risk of Severe Hypocalcemia
The FDA is investigating the risk of severe hypocalcemia with serious outcomes, such as hospitalization and death, in patients on dialysis taking denosumab.
FDA Approves Ustekinumab for Children with PsA
After examining study data from pediatric patients with both psoriasis and psoriatic arthritis (PsA), the FDA approved ustekinumab as a treatment for patients aged 6–17 years old with PsA.
TNF Inhibitors Associated with Neurological Adverse Events
A study examined the association between TNF inhibitors and neurological demyelinating adverse events in patients with rheumatoid arthritis and spondyloarthritis using cohort data from five Nordic countries. Researchers showed that patients with SpA were more likely to experience adverse events than patients with RA.
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