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ICYMI: Cardiac and Cancer Signals Tofacitinib Safety Alert from FDA
The FDA has notified healthcare professionals of a safety alert concerning tofacitinib (Xeljanz), noting that preliminary results from a long-term safety clinical trial show an increased risk of serious heart-related problems and cancer with tofacitinib (compared to adalimumab) when given to at-risk rheumatoid arthritis patients. These findings are in addition to the thrombotic risks (added to the label), potential risks including blood clots in the lungs and death.
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ICYMI: JAK Inhibitor Misses Endpoint in Safety Study. Now What?
Pfizer announced results Wednesday from its FDA-mandated postmarketing safety study of tofacitinib (Xeljanz), and they don't bode well for the drug and possibly others in its class.
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RheumNow Podcast – As Good As I Ever Was (7.2.2021)
Dr. Jack Cush reviews the news and journal reports from this past week on RheumNow.com.
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New ACR Rheumatoid Arthritis Guideline: Emphasis on Methotrexate
The American College of Rheumatology (ACR) has issued new guidelines on the treatment of rheumatoid arthritis, addressing questions about initial treatment with methotrexate and minimizing reliance on glucocorticoids.
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The Potential of Rituximab Efficacy in Systemic Sclerosis
Rituximab (RTX) has been in the news a lot lately; more surprisingly for its potential benefits in progressive systemic sclerosis (SSc).
Ebata and colleagues have published the results of a double-blind, randomised, placebo-controlled trial comparing intravenous RTX to placebo in 56 SSc patients. Patients had to have a modified Rodnan Skin Score (mRSS) of 10 or more. The primary endpoint was the change in mRSS at 24 weeks.
ACR Stands Against Insurer Mandated Infusion Locations
The American College of Rheumatology (ACR) has released an updated position statement on patient safety and site of service for biologics outlining several reasons why the ACR strongly believes infusions should be administered in a monitored health care setting with onsite supervision by a provid
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RheumNow Podcast – Modern Treatment of RA Pregnancy (6.25.2021)
Dr. Jack Cush reviews this week’s news and journal reports featured on RheumNow.com.
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Better Outcomes with Modern T2T in Pregnancy
With the expansion of knowledge regarding the safety of newer agents in pregnancy comes the PreCARA study showing that when pregnancy is planned and patients with rheumatoid arthritis (RA) are treated with a modified treat-to-target (T2T) approach, superior outcomes can be anticipated.
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Progression from Psoriasis to Psoriatic Arthritis
The question of whether psoriasis is a state or pre-clinical psoriatic arthritis has been addressed by several studies; with one suggesting that biologic use in psoriasis may aver the future development of psoratic arthritis (PsA).
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FINCH 1 Trial Filgotinib in Rheumatoid Arthritis
The Annals of Rheumatic Disease has published the results of a head-to-head trial showing that the Janus kinase-1 (JAK1) preferential inhibitor filgotinib was superior to a tumour necrosis factor-α inhibitor (adalimumab) in active rheumatoid arthritis (RA) on methotrexate (MTX).
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Treatment of MIS-C COVID in Kids
The NEJM has published results of a real-world efficacty trial showing that COVID infected children with the multisystem inflammatory syndrome in children (MIS-C) respond better to initial IVIG plus glucocorticoids (than IVIG alone) which was associated with less subsequent cardiovascular co
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Do B-cell targeted therapies still have a place for the treatment of Sjogren’s?
B-cells play a major role in the pathogenesis of primary Sjogren’s syndrome (pSS) through antibody-dependent and antibody-independent functions, as well as evident by progression to B-cell malignancies/lymphoma. Hence, targeting B-cell is attractive. Despite efficacy of B-cell depleting therapy with rituximab in Phase II trials and case series, it failed to meet its primary endpoint when investigated in two Phase III trials. It is worth noting that the primary endpoint used in both trials was a subjective measure. Post-hoc analyses however showed greater improvement in objective measures such as salivary flow rate and salivary gland ultrasound score in RTX-treated group vs placebo.
Therefore, do B-cell targeted therapies still have a place for the treatment of pSS?
Reader beware! Interpretation of effectiveness & safety of JAKi vs bDMARDs in real world data
Multiple studies compared effectiveness, retention and/or safety of biological DMARDs (bDMARDs) and JAK inhibitors (JAKi) at EULAR 2021.
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