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Best of 2021: FDA Puts Boxed Warnings on JAK Inhibitors
Based on the safety review of tofacitinib in Pfizer's Oral Surveillance (1133) study, the FDA has added serious boxed warnings to all three marketed JAK inhibitors (for inflammatory diseases) and formalized the recommendation that patients should be started on a TNF inhibitor (TNFi) before trying a JAK inhibitor. These recommendations apply to tofacitinib, baricitinib and upadacitinib.
Read ArticleBest of 2021: Tofacitinib Safety Concerns
Dr. Jack Cush reviews and discusses the news and journal reports from the past week on RheumNow.com.
Read ArticleIndications Awaiting (12.17.21)
There's good news and bad news in rheumatology fellowship matching for 2022. There's also new FDA approvals and indications, but a new serious safety warning has arisen from the CDC about the J&J COVID-19 vaccine.
Dr. Jack Cush reviews the latest news, journal reports, regulatory approvals, plus 3 new cases from rheumatologists.
Tofacitinib 1st JAK Inhibitor Approved for Ankylosing Spondylitis
The FDA approved tofacitinib (Xeljanz, Xeljanz XR) for treating active ankylosing spondylitis in adults, Pfizer announced on Tuesday.
Read ArticleRinvoq FDA Approved for Active Psoriatic Arthritis
The FDA has approved upadacitinib (Rinvoq) today for use in the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
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FDA Puts Boxed Warnings on JAK Inhibitors
Based on the safety review of tofacitinib in Pfizer's Oral Surveillance (1133) study, the FDA has added serious boxed warnings to all three marketed JAK inhibitors (for inflammatory diseases) and formalized the recommendation that patients should be started on a TNF inhibitor (TNFi) before trying a JAK inhibitor. These recommendations apply to tofacitinib, baricitinib and upadacitinib.
Read ArticleGiant Cell Arteritis Novel Treatment Options
Giant cell arteritis is associated with significant treatment related morbidity due to the dependence on glucocorticoids as a treatment option. After sixty years of therapeutic stagnation, these are exciting times in the management of GCA. At this year's ACR Convergence meeting, encouraging data will be presented on options for GCA.
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Emerging Therapies in Spondyloarthritis: A Promising Pipeline
Growing awareness of spondyloarthropathies over the last two decades has led to a better understanding of the pathophysiology of spondyloarthritis, and subsequently increased interest in more distinct, disease state specific treatment options.
Read ArticleAutoinflammatory: PAH in AOSD, VEXAS, JAKi in Still's, Role of labs in infections vs. flares Drs.Cush, Yusof, Mehta, Petryna and Tate review autoinflammatory data presented at #ACR21. @Yuz6Yusof @bella_mehta @DrPetryna @uptoTate https://t.co/oeAprkSBWZ https://t.co/1g9yRRFJqf
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Does Control of Inflammation Lower Cancer Risk?
Dr. Jonathan Kay's provocative video addresses whether the increased cancer risk associated with tofacitinib (Tofa) seen in the Pfizer Oral Surveillance (1133) study represents a real increased risk, an increased risk relative to a decreased risk with TNF inhibitors (TNFi) or an actual decreased cancer risk (unknown as there was no placebo comparator in this trial).
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Perspectives on CV safety: JAK inhibitor (Tofacitinib) and TNF inhibitors
Safety comparisons of JAKi (tofacitinib) vs. TNFi from Oral Surveillance showed that, in patients with active RA on MTX and aged >50 years with one or more CV risk factors, that there was numerically more MACE events, malignancies, and VTE especially in higher dose.
Read ArticleRheumNow Podcast - ACR 2021 Rehash (the good stuff..)
The ACR 2021 meeting has concluded. Dr. Jack Cush recounts a few more great abstracts from this past week’s virtual meeting.
Read ArticlePredicting RA, and Treatment of Subclinical Arthritis
Identifying patients that will develop RA in situations of seropositivity without overt clinical arthritis or identifying patients with undifferentiated oligo/polyarthritis that will develop RA remains a challenge in the field of rheumatology.
Read ArticlePedro Castillo _Castillo_Pedro ( View Tweet)