Antiphospholipid syndrome (APS) is an acquired thromboinflammatory disease that can have severe, sometimes catastrophic, effects on patients and their families. Our modern understanding of APS began to emerge in the early 1980s. At that point, it was defined as a condition characterized by thrombotic episodes and/or pregnancy complications in the presence of antiphospholipid antibodies (aPL).1…
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Pharmacokinetic Modeling & Efficacy Extrapolation: FDA Takes New Approaches to Drug Approvals
An array of new and expanded indications of therapeutics for rheumatic disease last year relied on pharmacokinetic modeling for intravenous dosing and efficacy extrapolation for pediatric populations.
Are We Making Progress in Treating Lupus? Clinical Insights from Dr. Michelle Petri
At the 19th Annual Advances in the Diagnosis and Treatment of the Rheumatic Diseases course, Dr. Michelle Petri gave a presentation concerning the overall state of lupus treatment outcomes in the U.S.
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…
Rheumatology Medications with Limited Safety Data: How Do We Use Them in Pregnant Patients?
How does a rheumatologist treat a pregnant woman when many medications are not approved for pregnancy or safety data are limited?
The Complexity of SLE Drug Research
PHILADELPHIA—On Saturday, Nov. 12, at ACR Convergence 2022, Joan T. Merrill, MD, director of clinical projects in the Arthritis & Clinical Immunology Program at the Oklahoma Medical Research Foundation in Oklahoma City, gave a presentation on the future of drug development and treatments for systemic lupus erythematosus (SLE). She described how an in-depth understanding of…
Updated Perioperative Guideline Released: Recommendations Balance Risks of Infection & Disease Flare
The 2017 recommendations are updated to reflect changes in medical literature, as well as to include newly approved drugs.
What’s New in SLE: Pathogenesis & Novel Therapies
Thomas Dörner, MD, reviewed the current state of systemic lupus erythematosus (SLE) management, providing updates on novel therapies and insights into the pathogenesis of SLE.
Dermatologist, Rheumatologist Discuss Refractory Cutaneous Lupus Case
As a dermatologist/internist with a career-long subspecialty interest in the cutaneous manifestations of the rheumatic diseases, I found the case of refractory acute cutaneous lupus by Samantha C. Shapiro, MD, in the June 2022 issue of The Rheumatologist intriguing in several ways, and I felt my perspectives on this case might provide additional educational value…
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