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.
Pregnancy Outcomes in Patients Treated with TNF Inhibitors
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.
Insight into the FDA Approval of Ustekinumab Biosimilar
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.
Clinical Year in Review: 2023
SAN DIEGO—At ACR Convergence 2023, Philip Seo, MD, MHS, presented an overview of clinical updates in rheumatology from the past year.
Risks of Severe HCQ Non-Adherence
Lower HCQ Serum Levels Associated with SLE Flare, Damage & Mortality Background & Objectives: Nguyen et al. set out to assess the consequences of severe non-adherence to hydroxychloroquine (HCQ) by measuring hydroxychloroquine serum levels, risks of systemic lupus erythematosus (SLE) flares, damage and mortality over five years of follow-up. Methods: The Systemic Lupus Erythematosus International…
Octagam Trial Results Show Promise
Since the New England Journal of Medicine publication on intravenous immune globulin (IVIG) for dermatomyositis late last year, the data have proved a major lift for patient care, offering crucial new insights into how best to manage patients and clues about how to minimize risks.1 The ProDERM trial results also seem to have opened up…
FDA Approves New Biosimilar for Adult & Pediatric Arthritis
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.
FDA Approves Canakinumab to Treat Gout Flares
Canakinumab has received FDA approval for the treatment of patients with acute gout flares.
FDA Accepts NDA for Investigational RA Agent
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.
FDA Grants Interchangeable Designation to Pfizer’s Abrilada, Biosimilar to AbbVie’s Humira
On Oct. 5, Pfizer announced that Abrilada (adalimumab-afzb), its biosimilar to Humira (adalimumab), had received an interchangeable designation from the U.S. Food & Drug Administration (FDA).
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