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Drug Safety

Canakinumab Use in Periodic Febrile Disorders

Sep 16, 2021

A retrospective records review of patients with periodic fever syndromes (PFS)  receiving IL-1 inhibitor treatment with canakinumab (CAN), shows CAN to be effective and safe in a variety of PFS patients.

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Different Regimens but Equal Outcomes in Polyarticular JIA

Sep 15, 2021

CARRA (Childhood Arthritis and Rheumatology Research Alliance) has compared 3 different treatment strategies for polyarticular JIA to identify the optimal time to biologic regimen.



This prospective observational study used data from the STOP-JIA trial (Start Time Optimization of

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ACR Comments on JAK Inhibitors and FDA Announcement

ACR
Sep 13, 2021

Following is a statement from ACR President David Karp, MD, PhD, on JAK inhibitors and FDA drug safety communication.

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RheumNow Podcast – High Science and Future Treatments (9.10.2021)

Sep 10, 2021

This week: high science that affect future treatments; breakthrough infections in our patients, and what's up with that; and soon your radiologist is going to be replaced by AI. This and more in our review of the news and journal articles from the past week.

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FDA Review of Vaping Products Extended

Sep 09, 2021

The FDA has again extended its decision on whether the manufacturers of vaping products can market their e-cigarettes in the United States.



Previously, the manufacturers (Juul, Vuse and Blu) were given until September 2020 to submit data to the FDA on the use and safety of these

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Telephone survey of 278 Rheumatic Pts during COVID (July 2020) showed 22% reduced/interrupted treatments, only 11 (4%) stopped. Decisions made by half (49%). Stop Reasons: anxiety (48%), IV Rx access (45%), Rx unavailability (6.5%) https://t.co/XgJ1TJsHJG

Dr. John Cush @RheumNow( View Tweet )

Sep 09, 2021

Lymphoma in RA: Disease Activity Matters

MedPage Today
Sep 08, 2021

Among patients with rheumatoid arthritis (RA), the strongest risk factors for the development of lymphoma were disease activity and severity, French researchers found.

In a multivariate analysis, having a high Disease Activity Score in 28 joints (DAS28) at baseline conferred twice the risk for

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Dr. Cush is joined by rheumatology colleagues to discuss impressions and impact of the 9/1/21 FDA Drug Safety Communication to physicians regarding new label changes. #RheumNow https://t.co/F37SCpJnsW https://t.co/uhdOjFo0yP
Dr. John Cush @RheumNow( View Tweet )
Sep 08, 2021
Pleased to share our study in A&R investigating rheum evaluation, immunomodulator use, and predictors of rheumatic immune-related adverse events (irAEs) after immune #checkpoint inhibitor use for cancer, led by @BusselKiki @BrighamResearch @DanaFarber https://t.co/6rnSfd08FB

Jeffrey Sparks MD MMSc @jeffsparks( View Tweet )

Sep 06, 2021
FDA JAKi Warnings, 2nd Panel of rheumatologists weigh in on this. Drs. Cush, Dao, Tate, Sparks, Shergy. https://t.co/eETzP8DspC via @YouTube #RheumNow @KDAO2011 @uptoTate @jeffsparks @WilliamShergy https://t.co/iqxFQjJQ0l
Dr. John Cush @RheumNow( View Tweet )
Sep 06, 2021
ICYMI: FDA slaps new BOXED warning revision on ALL JAK inhibitors (Xeljanz, Olumiant, Rinvoq) after final revew of the Pfizer Oral Surveillance study. New warnings for incr risk of MI, CVA, VTE, lymphoma & death see w/ BOTH dose of tofacitinib. https://t.co/tvTv40oy59

Dr. John Cush @RheumNow( View Tweet )

Sep 04, 2021
FDA JAK inhibitor warnings and what it means (also: what do you think?); other news released this week; and, two questions submitted from listeners. Dr. Cush discusses this and more in this week's podcast. https://t.co/4jTBhYDzRn https://t.co/lMpl2IOeXe
Dr. John Cush @RheumNow( View Tweet )
Sep 03, 2021

RheumNow Podcast – JAK Inhibitor Warnings from the FDA

Sep 02, 2021

FDA JAK inhibitor warnings and what it means (also: what do you think?); other news released this week; and, two questions submitted from listeners. Dr. Cush discusses this and more in this week's podcast.

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Expert Panel: Initial Views on FDA Warnings for JAK Inhibitors

Sep 02, 2021

Dr. Jack Cush is joined by Drs. Roy Fleischmann (Dallas), Allan Gibofsky (NYC), and Artie Kavanaugh (San Diego) to discuss the 9/2/21 FDA Drug Safety Communication regarding the cardiovascular and cancer risks arising from the Pfizer 1133 (ORAL Surveillance) tofacitinib study, but also applied

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Steroid (GC) discontinuation from the BeSt and IMPROVED trials shows that w/ GC d/c 40% of RA pts Flare and 50-60% restart GC. Similar outcomes w/ 2nd attempt at GC d/c. Lower DAS28 scores had better odds of GC D/C. https://t.co/PtbgONNMwW

Dr. John Cush @RheumNow( View Tweet )

Sep 02, 2021
The FDA announced its findings regarding tofacitinib's safety concerns from the Oral Surveillance study - handing down warnings for not only Pfizer's JAK inhibitor, but also for other marketed JAK inhibitors from AbbVie and Eli Lilly & Co. https://t.co/jayl8ufPHn https://t.co/zNvPiVcdOM
Dr. John Cush @RheumNow( View Tweet )
Sep 02, 2021
Newly Revised Xeljanz Boxed Warning. New Changes highlighted in yellow. https://t.co/jayl8tYeiN https://t.co/5tXX00UgBD
Dr. John Cush @RheumNow( View Tweet )
Sep 01, 2021
FDA slaps new BOXED warning revision on ALL JAK inhibitors (Xeljanz, Olumiant, Rinvoq) after final revew of the Pfizer Oral Surveillance study. New warnings for incr risk of MI, CVA, VTE, lymphoma & death see w/ BOTH dose of tofacitinib. https://t.co/tvTv40oy59

Dr. John Cush @RheumNow( View Tweet )

Sep 01, 2021

FDA: New Cardiac and Cancer Warnings for All JAK Inhibitors

Sep 01, 2021

Today, Sept.1st, the FDA announced its decision regarding tofacitinib's safety concerns from the Oral Surveillance study - handing down warnings for not only Pfizer's JAK inhibitor, but also for other marketed JAK inhibitors from AbbVie and Eli Lilly & Co.

These safety concerns arise from

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TNF Inhibitor Induced IgA Vasculitis in IBD

Aug 31, 2021

A new descriptive series shows an uncommon association between IgA vasculitis (IgAV) and inflammatory bowel diseases (IBD), with most cases interestingly arising after  or during anti-TNF-α therapy.



A retrospectively analysis of the GETAID and FVSG networks identified, 43 patients

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Gut microbiome strongly influences irAE's in advanced melanoma pts taking checkpoint blockade targeting CTLA-4 and PD-1. Signatures for Bacteroides intestinalis & Intestinibacter bartlettii more grade 3+ irAE by inducing IL-1B https://t.co/rEHknJ3TSC

Dr. John Cush @RheumNow( View Tweet )

Aug 31, 2021

Drug Choices After First TNF Inhibitor in RA

Aug 30, 2021

TNFi are frequently used first line in RA patients; and a new analysis shows that repeat use of TNFi dominates over the use of non-TNFi biologics when the initial TNFi therapy has failed. This retrospective analysis of commercial insurance records analyzed the patterns of drug use in adult RA

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Rheumatic Events With Checkpoint Inhibitors: Tumor Type Matters https://t.co/vT6185ycoG https://t.co/G14eLN2JkT
Dr. John Cush @RheumNow( View Tweet )
Aug 29, 2021

RheumNow Podcast – COVID Marching Amidst the Madness (8.27.2021)

Aug 26, 2021

We have a lot of news, information and approvals to review and discuss, though I need to begin with what's weighing heavily on my mind. After, we'll dive into what we learned this week.

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Rare Risks Associated with BNT162b2 mRNA Covid-19 Vaccine

Aug 26, 2021

The current NEJM reports that the use of the Pfizer mRNA vaccine (BNT162b2) demonstrated a very low risk for certain serious adverse events, including the risk of myocarditis (1 to 5 events per 100,000 persons). 



The paper examines the safety of the BNT162b2 mRNA vaccine and a broad

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