Early study results demonstrate that rosnilimab may be safe and effective for patients with rheumatoid arthritis, reducing the signs and symptoms of RA by week 12 and achieving important primary and secondary study end points.
Biosimilar Update: 2025 Brings More FDA Approvals & Interchangeability
Here is a brief recap of the latest FDA-approved biosimilar agents, highlighting their reference products and interchangeability.
FDA Approves Upadacitinib for GCA
Supported by data in patients with new-onset and relapsing giant cell arteritis (GCA), the FDA approved upadacitinib for the treatment of adults with GCA.
Abatacept Shows Promise for Some Myositis Patients
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
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
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
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
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
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
FDA has granted Descartes-08, an mRNA chimeric antigen receptor T cell therapy, a rare pediatric disease designation for the treatment of juvenile dermatomyositis.
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