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Biologics/DMARDs

Abatacept Shows Promise for Some Myositis Patients

Deborah Levenson  |  May 12, 2025

Injected abatacept may be a worthwhile treatment for certain patients with idiopathic inflammatory myositis (IIM), according to recent research.1 Patients with the rare autoimmune conditions involving inflammation of muscle (myositis) and other organ systems suffer widespread organ dysfunction, increased morbidity, physical disabilities and early death. Symptoms vary by subtype. For example, dermatomyositis (DM) involves muscle…

Cilnidipine Receives Orphan Drug Status to Treat Systemic Sclerosis

Michele B. Kaufman, PharmD, BCGP  |  May 9, 2025

Based on research showing improved signs and symptoms of systemic sclerosis in patients taking cilnidipine vs. placebo, the FDA granted orphan drug designation for the agent.

Nipocalimab Receives Breakthrough Therapy Status for Sjögren’s Disease

Michele B. Kaufman, PharmD, BCGP  |  May 9, 2025

Nipocalimab, an investigational monoclonal antibody that blocks FcRn and reduces levels of circulating immunoglobulin G (IgG) antibodies, has received the FDA’s breakthrough therapy designation for the treatment of Sjögren’s disease.

Trends in the Use of DMARDs for Patients with JIA

Arthritis & Rheumatology  |  April 8, 2025

Yalamanchili et al. describe how trends in disease-modifying anti-rheumatic drug (DMARD) use have evolved for insured, U.S. patients with juvenile idiopathic arthritis. Overall, the study found that from 2000 to 2022 in this patient population the use of biologic and targeted synthetic DMARDs rose, while the use of conventional synthetic DMARDs declined.

Deucravacitinib Promising for PsA

Michele B. Kaufman, PharmD, BCGP  |  February 12, 2025

Results from two studies found that deucravacitinib improved the signs and symptoms of patients with psoriatic arthritis who were biologic disease-modifying anti-rheumatic drug naive and those previously treated with a tumor necrosis factor α inhibitor.

FDA Approval Sought for 2 Pediatric Indications for Guselkumab

Michele B. Kaufman, PharmD, BCGP  |  February 11, 2025

The FDA is reviewing supplemental biologics license applications for guselkumab to treat children with juvenile psoriatic arthritis and moderate to severe plaque psoriasis.

mRNA CAR T Cell Therapy Receives FDA’s Rare Pediatric Designation to Treat Juvenile Dermatomyositis

Michele B. Kaufman, PharmD, BCGP  |  January 30, 2025

FDA has granted Descartes-08, an mRNA chimeric antigen receptor T cell therapy, a rare pediatric disease designation for the treatment of juvenile dermatomyositis.

Reproductive Health, Biosimilars & More in Focus at SOTA 2025

Ruth Jessen Hickman, MD  |  January 30, 2025

Reproductive health, biosimilars, IgG4-related disease and much more—five speakers give us a sneak peek into important topics being addressed at the ACR’s 2025 State-of-the-Art Clinical Symposium, April 4–6.

FDA Approves Bimekizumab-bkzx (Bimzelx) for 3 New Rheumatic Indications

Michele B. Kaufman, PharmD, BCGP  |  December 30, 2024

The FDA has approved bimekizumab-bkzx for the treatment of adults with psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

The Ethical Tug-of-War Over Biosimilar Adoption

Karen Ferguson, MS, & Richard L. Allman, MD, MS, FACP, FACR  |  December 9, 2024

The advent of biosimilar medications has offered the promise of significant cost savings for healthcare systems and patients. Biosimilars are highly similar versions of existing biologic drugs, providing a more affordable alternative once the original biologic patent expires. However, the adoption of biosimilars in the U.S. has been hampered by myriad roadblocks, many of which…

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