The ACR has released a statement, responding positively to the release of the latest U.S. Food and Drug Administration (FDA) draft guidance on biosimilar drug development. Also, BI 695501, a biosimilar to Humira (adalimumab) made by Boehringer Ingelheim, has been accepted for regulatory review in both the U.S. and Europe. ACR Responds to FDA Biosimilar…
Herpes zoster (HZ) infection, also known as shingles, is caused by reactivation of latent varicella-zoster virus infection generally acquired decades earlier. This study was designed to test the hypothesis that the incidence of stroke immediately following HZ infection is increased in patients with autoimmune diseases compared with the incidence of stroke at later time points. Results: In patients with autoimmune diseases, incident HZ was associated with as much as a twofold increased risk of stroke. Prompt antiviral therapy was associated with lower incidence of subsequent stroke…
The ACR recently partnered with the American Medical Association (AMA) and a coalition of 16 other organizations representing physicians, medical groups, hospitals, pharmacists and patients to dramatically reshape prior-authorization protocols. The coalition is urging an industry-wide reassessment of these protocols to align with a newly created set of 21 principles, called the Prior Authorization and…
FDA Review of Baricitinib Delayed The U.S. Food and Drug Administration (FDA) has extended the review period for baricitinib, an investigational medication for treating moderate to severe rheumatoid arthritis (RA).1 Baricitinib is a once-daily oral Janus kinase (JAK) inhibitor currently in clinical studies for inflammatory and autoimmune diseases. The New Drug Application (NDA) for baricitinib…
EULAR has updated its recommendations for the management of early arthritis, outlining aspects of diagnosis and drug treatments…
Wash your hands. This most basic tenet of proper hygiene has been drummed into our heads for years. It’s an obvious infection prevention activity, yet for years, compliance among physicians and other caregivers has been lackluster. To rectify this matter, regulatory agencies began auditing hospital staff adherence to this axiom of infection prevention. Not only…
The Case You’re working in a busy rheumatology practice with wait times of two to three months for new outpatient consultations. A hospital administrator requests that his daughter see you right away. All but one of your urgent appointment slots for the week is already filled, and there are several patients on a waitlist; these…
Although gout is one of the most effectively treated of all rheumatic diseases, it is among the worst-managed diseases long term, as shown by many studies. “Treatments are excellent, yet are dramatically under-utilized,” says Theodore Fields, MD, FACP, rheumatologist, Hospital for Special Surgery (HSS), New York. “This is because some gout patients feel better between…
GCA Relapse Possible When Discontinuing Tocilizumab In a Phase 2 randomized, controlled trial, tocilizumab, an anti-IL-6 biologic agent, was shown to induce and maintain remission for up to 52 weeks in patients with giant cell arteritis (GCA).1 During this trial, patients with GCA were randomized in a 2:1 ratio to receive 8 mg/kg bodyweight tocilizumab…
New Rheumatologist at Minnesota Clinic Meghan Scheibe, MD, is pleased with her new position at CentraCare Clinic Rheumatology and Infusion Services, a hospital-based practice in St. Cloud, Minn. “It’s a great practice,” says Dr. Scheibe. “Young, energetic partners and wonderful support staff. I’m seeing four to six new patients a day.” These are patients who had…