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Biologics/DMARDs

Study: Patients with PMR Experience Fatigue, Sleep Disturbance & Mood Disorders

Jessica Leung, MBBS, FRACP, Claire E. Owen, MBBS, PhD, FRACP, David Liew, MBBS, FRACP, & Russell Buchanan, MBBS, MD, FRACP  |  January 24, 2024

Background/Purpose Polymyalgia rheumatica (PMR) is typified by pain and stiffness of the shoulder and hip girdles. Previous qualitative studies have highlighted the importance to patients of additional symptoms, including fatigue and sleep disturbance. These features of PMR are less recognized by clinicians and have not yet been quantified in the literature. Further, the adequacy of…

Long-Term Voclosporin Treatment Looks Promising for Lupus Nephritis Patients

Arthritis & Rheumatology  |  January 9, 2024

AURORA 2, a double-blind, phase 3 study, evaluated the long-term safety, tolerability and efficacy of voclosporin compared to placebo in patients with lupus nephritis receiving an additional two years of treatment following completion of the one-year AURORA 1 study. Patients enrolled in AURORA 2 continued to receive the same treatment randomly assigned in AURORA 1, in combination with mycophenolate mofetil and low-dose glucocorticoids. Saxena et al. propose that the rapid renal response achieved with voclosporin treatment has long-term benefits, supported by stable kidney function over the three-year treatment period.

Pharmacokinetic Modeling & Efficacy Extrapolation: FDA Takes New Approaches to Drug Approvals

Thomas R. Collins  |  January 4, 2024

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

Michele B. Kaufman, PharmD, BCGP  |  December 18, 2023

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

Michele B. Kaufman, PharmD, BCGP  |  December 14, 2023

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

Samantha C. Shapiro, MD  |  December 4, 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

Arthritis & Rheumatology  |  November 30, 2023

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…

FDA Approves New Biosimilar for Adult & Pediatric Arthritis

Michele B. Kaufman, PharmD, BCGP  |  November 6, 2023

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

Michele B. Kaufman, PharmD, BCGP  |  November 3, 2023

Canakinumab has received FDA approval for the treatment of patients with acute gout flares.

FDA Accepts NDA for Investigational RA Agent

Michele B. Kaufman, PharmD, BCGP  |  November 1, 2023

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.

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