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Integrating Immunology and Biologics into Clinical Practice

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With the rapid expansion of new classes of medications, clinical practice has changed dramatically, and rheumatology health professionals must have a fundamental knowledge of immunology and the mechanisms of action of the biologic agents that have emerged with this expansion. Familiarity with the predrug screening recommended for biologic agents and the appropriate safety and disease monitoring necessary when a person uses these products is essential for the best patient outcomes. Additionally, being able to obtain drug plan authorization for use of biologics and being able to educate patients and their families or support team members about the financial considerations of these drugs helps to ensure best rheumatology practice.

EU Recommends Approval of Anifrolumab Auto-Injector

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Research demonstrating the effectiveness of subcutaneous anifrolumab-fnia as an auto-injector in patients with active systemic lupus erythematosus is the basis of a recent decision in the EU to recommend the treatments approval for this patient population.

Trials Find Potential Treatments for SLE, Lupus Nephritis

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In summer 2024, two phase 3 studies were released with promising findings for the treatment of patients with systemic lupus erythematosus (SLE) and those with lupus nephritis. SLE Disease Activity Dapirolizumab pegol is a novel, investigational, Fc-free anti-CD40L agent for people living with moderate to severe SLE.1 The randomized, double-blind, parallel-group PHOENYCS GO trial (N=321)…

Belimumab Promising for Children with Lupus Nephritis

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In late July 2022, the U.S. Food & Drug Administration (FDA) approved belimumab (Benlysta) for the treatment of children with active lupus nephritis aged 5 to 17 years old receiving standard therapy.1 Despite recent advances in treatment options for patients with systemic lupus erythematosus (SLE), those with kidney involvement may develop endstage renal disease and…

60-Day Comment Period Opens for FDA’s Draft Guidance on Biosimilars

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The FDA has issued draft guidance recommending that all biosimilar medications be designated as interchangeable with their reference products upon initial FDA approval. A 60-day review and comment period of the draft guidance is now open, and the ACR will soon be submitting comments.