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.
In January, the U.S. Food & Drug Administration approved indomethacin in an oral suspension, a generic version of Indocin Oral Suspension. The agency also issued a boxed warning and updated label for denosumab, warning of the risks of severe hypocalcemia in patients with chronic kidney disease.
On Feb. 28, 2023, the U.S. Food & Drug Administration (FDA) approved sarilumab (Kevzara) for the treatment of adults with polymyalgia rheumatica (PMR) for whom glucocorticoids have proved inadequate or who cannot tolerate a glucocorticoid taper.1,2 Sarilumab is an interleukin (IL) 6 receptor antagonist. In May 2017, the FDA initially approved the agent for the…
What Are the Therapeutic Alternatives When a Janus Kinase Inhibitor Fails to Work? SAN DIEGO—Treatment alternatives after Janus kinase (JAK) inhibitor failure in real-life conditions were analyzed and presented at ACR Convergence 2023 by Pablo Francisco Muñoz Martínez, a rheumatologist at the Hospital Universitario y Politécnico La Fe, Sagunto, Spain.1 JAK inhibitors are newer, targeted…
A study found the continuation of tumor necrosis factor inhibitor (TNFi) treatment in patients with chronic rheumatic inflammatory diseases after pregnancy diagnosis was not associated with worse outcomes than those who discontinued treatment with TNFi’s.
In late October, the FDA approved the first biosimilar to ustekinumab to treat patients with psoriasis, psoriatic arthritis and other conditions. Ustekinumab-auub is expected to be available in the U.S. by 2025.
This year, tocilizumab biosimilars have been approved to treat adult and pediatric patients with rheumatic disease, including rheumatoid arthritis, juvenile idiopathic arthritis and more, in both Europe and the U.S.
Canakinumab has received FDA approval for the treatment of patients with acute gout flares.
The FDA has accepted an investigational new drug application (NDA) for MYMD-1, an oral tumor necrosis factor-α inhibitor for patients with rheumatoid arthritis.
St.Clair et al. found that patients with Sjögren’s disease treated with dazodalibep experienced greater improvement in key symptoms of dryness, fatigue and pain than patients who received placebo.
In Japan, ozoralizumab will soon be available as a 30 mg subcutaneous auto-injection to treat patients with rheumatoid arthritis.