FDA to Review AVT02, a High Concentration Biosimilar to Adalimumab
AVT02 is a proposed biosimilar to Humira® (adalimumab) with high concentration (100mg/mL) dosage forms.
General Rheumatology
No Increased Cardiovascular Risk With Febuxostat vs Allopurinol
In contrast to CARES, FAST found that treatment with febuxostat was not associated with an increase in cardiovascular or all-cause death compared with allopurinol in patients with gout.
Simponi Aria Approved for Polyarticular JIA, Pediatric Psoriatic Arthritis
Simponi Aria is available as a 50mg/4mL strength solution for IV infusion; it is administered as a 30-minute infusion.
Xeljanz Approved for Active Polyarticular Course Juvenile Idiopathic Arthritis
Patients treated with tofacitinib experienced significantly fewer disease flares compared with placebo.
Newly Diagnosed Lupus Erythematosus Could Potentially Be Drug Induced
A new case of cutaneous lupus erythematosus or systemic lupus erythematosus could potentially be drug induced.
Upadacitinib Application for Ankylosing Spondylitis Submitted for Review
The application is supported by data from the multicenter, double-blind, placebo-controlled phase 2/3 SELECT-AXIS 1 study.
FDA Rejects Filgotinib NDA for Rheumatoid Arthritis
The FDA has issued a Complete Response Letter (CRL) to Gilead Sciences related to the New Drug Application (NDA) for filgotinib in the treatment of moderately to severely active rheumatoid arthritis.
Biosimilar Hulio Gets FDA Approval
The Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp; Mylan), a biosimilar to Humira® (adalimumab; AbbVie).
Updated 2020 American College of Rheumatology Gout Management Guidelines
The American College of Rheumatology developed guidelines for the management of gout, including use of urate-lowering therapy, flare treatment, and lifestyle and medication recommendations.
Trial Investigating Ustekinumab for Systemic Lupus Erythematosus Discontinued
Janssen has decided to discontinue the phase 3 LOTUS study evaluating ustekinumab (Stelara®) for the treatment of systemic lupus erythematosus.
