ACR Convergence 2021—The recent Boxed Warning requirement applied to three Janus kinase (JAK) inhibitors, cautioning doctors and patients about several major risks in patients with rheumatoid arthritis, came only after rigorous data collection and careful consideration of the risks and the benefits, U.S. Food & Drug Administration (FDA) officials said in November at ACR Convergence…
FDA Approves First Interchangeable Biosimilar to Adalimumab, Plus a Combination Drug Approved
Cyltezo (adalimumab-adbm) may be interchanged for Humira (adalimumab) for all indications, according to an October decison by the FDA. The FDA has also approved a new combination of celecoxib and tramadol for pain management.
Considerations for Prescribing Avacopan for ANCA-Associated Vasculitis
In early October, the FDA approved avacopan to treat anti-neutrophil cytoplasmic antibody associated vasculitis. Here are insights into the treatment’s risks and considerations.
TNF Inhibitors & Pregnancy: How Well Does the Treatment Guidance Work?
Ghalandari et al. sought to validate the guidance outlined by EULAR for the use of anti-rheumatic drugs during pregnancy, finding that following its guidance for tumor necrosis factor inhibitors led to no or low concentrations of these agents in cord blood.
FDA Approves Cyltezo, an Interchangeable Biosimilar to Humira
On Oct. 15, the U.S. Food & Drug Administration (FDA) approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to and interchangeable with (i.e, may be substituted for) its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar…
A Dematologist’s Perspective on Choosing an Anti-Psoriatic Drug
We are fortunate to have clinical practice guidelines for the management of psoriasis and psoriatic arthritis (PsA) from multiple organizations to help navigate today’s rapidly evolving therapeutic landscape. We are further fortunate to have multiple specialists to manage these conditions: rheumatologists and dermatologists. However, multiple guidelines, multiple drugs and multiple specialists can create a paradox…
Trial Pits Upadacitinib vs. Adalimumab for Psoriatic Arthritis
As treatments for psoriatic arthritis (PsA) emerge, a clinical trial comparing the Janus kinase (JAK) inhibitor upadacitinib and the tumor necrosis factor (TNF) inhibitor adalimumab provided some new insights. Published earlier this year in The New England Journal of Medicine, the SELECT-PsA 1, double-blind, phase 3 trial found that a 30 mg dose of upadacitinib…
Tips for Transitioning Patients from Pediatric to Adult Rheumatology Care
Approximately 50% of young adult patients with childhood-onset rheumatic diseases become lost to follow-up within the first year of transferring to adult rheumatology care, mirroring the statistics of other subspecialties.1,2 One of the challenges cited most consistently by young adult patients and their families relates to differences between rheumatology care delivery in the pediatric and…
Psoriatic Arthritis Treatment Update
About 30% of patients with psoriasis have psoriatic arthritis (PsA), a complex, multi-faceted, chronic, inflammatory musculoskeletal and skin disease for which the treatment has changed considerably over the past few years.1 Biosimilars and other new drugs have become a therapeutic turning point for many patients suffering from rheumatic illnesses, including PsA. The treatment of PsA…
FDA Approves Avacopan for the Treatment of ANCA-Associated Vasculitis
On Oct. 8, ChemoCentryx Inc. announced that the U.S. Food & Drug Administration (FDA) has approved avacopan (TAVNEOS), an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms…
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