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Biologics/DMARDs

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.

FDA Grants Interchangeable Designation to Pfizer’s Abrilada, Biosimilar to AbbVie’s Humira

Keri Losavio  |  October 5, 2023

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).

Glucocorticoid Use at Any Dose Increases Fracture Risk

Arthritis & Rheumatology  |  September 26, 2023

The accepted wisdom is that the negative effects of glucocorticoids on bone depend on the dose and treatment duration. Adami et al. conducted this study to determine, in a real-life setting, the risk of fragility fracture associated with the dose of glucocorticoids in patients with inflammatory rheumatic musculoskeletal diseases.

Findings from a Clinical Trial of Dazodalibep for Sjögren’s Disease

Michele B. Kaufman, PharmD, BCGP  |  September 26, 2023

St.Clair et al. found that patients with Sjögren’s disease treated with dazodalibep experienced greater improvement in key symptoms of dryness, fatigue and pain than patients who received placebo.

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