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 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.
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.
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.
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.
The FDA is investigating the risk of severe hypocalcemia with serious outcomes, such as hospitalization and death, in patients on dialysis taking denosumab.
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.
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.
The FDA has approved upadacitinib for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) based on a short-term study that demonstrated improved pain, function and other symptoms of nr-axSpA in patients with active disease.
Belimumab is now FDA approved to treat children aged 5 years and older with active lupus nephritis, providing treatment options for pediatric patients at risk of developing renal damage.
A study has shown that in untreated patients with early RA, treatment with methotrexate combined with the biologic therapies abatacept or certolizumab-pegol resulted in greater CDAI remission rates than active conventional therapy with prednisolone, sulfasalazine or hydroxychloroquine.