Phase 3 REGENCY data: Obinutuzumab & standard therapy improve complete renal response rates in active lupus nephritis patients.
FDA Approvals: Lupus Nephritis
Lupus nephritis is one of the leading causes of mortality for patients with systemic lupus erythematosus (SLE), and patients with both SLE and end-stage renal disease have standardized mortality ratios more than 60 times that of patients with SLE with normal kidney function.1 The good news: Rheumatologists now have not one, but two approved options…
Trials Find Potential Treatments for SLE, Lupus Nephritis
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
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…
Kidney Biopsy in Lupus Nephritis
As part of a session on lupus nephritis at ACR Convergence 2023, Simone Appenzeller, MD, PhD, shared perspectives on the importance of biopsy to inform the diagnosis, prognosis and treatment of the condition, with an emphasis on childhood disease. Prompt diagnosis and treatment of lupus nephritis is perhaps even more important for children than for…
The ACR Releases New Lupus Nephritis Guideline
At a session of ACR Convergence 2024, speakers shared key elements of the new guideline on the screening, treatment and overall management of lupus nephritis in children and adults.1 This guideline attempts to balance the risks of medication side effects with the important goal of preserving kidney function. This is the ACR’s first lupus guideline…
Neutrophilic Inflammation in Spondyloarthritis
CHICAGO—In the basic science session, Beyond NETs: Alternative Roles of Neutrophils in Spondyloarthritis, neutrophils are explored as a common pathophysiologic thread among the spondyloarthropathies. In this two-part talk, Dennis McGonagle, PhD, professor of investigative rheumatology at the Leeds Institute of Rheumatic and Musculoskeletal Medicine at St James Hospital, Leeds, England, opens by examining the role…
Research Reviews: AURORA 2, & Urinary Biomarkers
AURORA 2 Voclosporin, a novel calcineurin inhibitor (CNI), is associated with a favorable metabolic profile with regard to lipids and glucose, and a predictable pharmacokinetic profile, resulting in no need for the therapeutic drug monitoring required of other CNIs. AURORA 2, a double-blind, phase 3 study, evaluated the longterm safety, tolerability and efficacy of voclosporin…
60-Day Comment Period Opens for FDA’s Draft Guidance on Biosimilars
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.
Autoantibodies Illuminate Lupus Nephritis
In this study, Fava et al. investigated longitudinal autoantibody profiles in a racially diverse cohort of patients with lupus nephritis to define noninvasive serological biomarkers of histologic class and one-year treatment response to standard of care. In addition, the researchers determined how these biomarkers changed over time to provide further insights into treatment response and…