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.
Psychosocial Factors & Pain in Hand Osteoarthritis
Attention to factors beyond the standard nociceptive model of painin patients with hand OA, including psychosocial considerations &other comorbidities, may impact a patient’s pain perception &pain course.
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…
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…
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…
SAP-001 Promising for Refractory Gout
Initial findings from a phase 2b clinical trial demonstrate the safety and efficacy of three different daily doses of SAP-001 to lower the serum urate levels of patients with refractory gout.
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.
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