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JAK panel presentation FDA

Expert Panel: Initial Views on FDA Warnings for JAK Inhibitors

Jack Cush, MD

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 to baricitinib and upadacitinib.

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FDA, warning, side effect

FDA: New Cardiac and Cancer Warnings for All JAK Inhibitors

Jack Cush, MD

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 the Oral Surveillance study - a large, post-marketing, safety trial of tofacitinib versus adalimumab in high risk patients. New warnings about the risks of cardiac events, death and cancer will appear as a revision to the "boxed warnings" in the product label (package insert) for all JAK inhibitors - tofacitinib, baricitinib and upadacitinib. 

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RheumNow Podcast – Booster Shots for COVID (8.13.2021)

Jack Cush, MD

Dr. Jack Cush reviews the news and journal reports from the past week on RheumNow.com.

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SI,Sacroiliac,Erosion,MRI

Early MRI Sacroiliac Improvement with JAK Inhibition

Jack Cush, MD

The TORTUGA trial tested filgotinib, a JAK1 inhibitor, in active ankylosing spondylitis (AS) patients and was shown to be both effective and capable of retarding sacroiliac (SI) joint erosions as early as 12 weeks.

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RA, hands, MCP, deformity

Combo Methotrexate and Leflunomide Safety in RA

Jack Cush, MD

Methotrexate and leflunomide (LEF) are the most widely prescribed DMARDs worldwide; yet biologic DMARDs are the newest and best selling agents for rheumatoid arthritis worldwide.

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ICYMI: RheumNow Podcast – Tofacitinib Safety Concerns

Jack Cush, MD

Dr. Jack Cush reviews and discusses the news and journal reports from the past week on RheumNow.com.

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2020 Year Review

ICYMI: 2020 Rheumatology Year in Review

Jack Cush, MD

2020 was historic, memorable and game-changing. Under the cloud of COVID-19, there were many significant and memorable advances and setbacks for the rheumatology world. In our accounting of most read articles for 2020, (not surprisingly) 17/20 were COVID-related.

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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

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Dr. John Cush RheumNow ( View Tweet)
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

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Dr. John Cush RheumNow ( View Tweet)

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

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Dr. John Cush RheumNow ( View Tweet)
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

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Dr. John Cush RheumNow ( View Tweet)
Newly Revised Xeljanz Boxed Warning. New Changes highlighted in yellow. https://t.co/jayl8tYeiN https://t.co/5tXX00UgBD

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Dr. John Cush RheumNow ( View Tweet)
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

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Dr. John Cush RheumNow ( View Tweet)

ICYMI: European Commission approves upadacitinib (Rinvoq)-first JAK Inhibitor for use in adults & adolescents with Moderate to Severe Atopic Dermatitis. UPA is approved for atopic dermatitis in other nations, Russia, Saudi Arabia; pending review in US https://t.co/hiPkJoJCex

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Dr. John Cush RheumNow ( View Tweet)

European Commission approves upadacitinib (Rinvoq)-first JAK Inhibitor for use in adults & adolescents with Moderate to Severe Atopic Dermatitis. UPA is approved for atopic dermatitis in other nations, Russia, Saudi Arabia; pending review in US https://t.co/hiPkJoJCex

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Dr. John Cush RheumNow ( View Tweet)

Interesting case report of difficult periorbital Discoid lupus erythematosus (DLE) treated with topical tofacitinib, 2%, ointment, a topical Janus kinase (JAK) 1/3 inhibitor. https://t.co/NZxUFW9ilN

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Dr. John Cush RheumNow ( View Tweet)

The TORTUGA trial tested filgotinib, a JAK1 inhibitor, in active ankylosing spondylitis (AS) patients and was shown to be both effective and capable of retarding sacroiliac (SI) joint erosions as early as 12 weeks. https://t.co/awfZdiTUBt https://t.co/ST2JIkavhy

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Dr. John Cush RheumNow ( View Tweet)
Registry data suggests an increased risk of herpes zoster (HZ, shingles) in rheumatoid arthritis (RA) patients taking JAK inhibitors (JAKi) but also with other biologic DMARDs, compared to csDMARDs. https://t.co/Uu1VjAbKMi https://t.co/uGvTyLExjf

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Dr. John Cush RheumNow ( View Tweet)
Another report of JAK inhibitor working in GVHD - Successful treatmente of joint & fascial involvement in GVHD with baricitinib. https://t.co/TQlPLCD2T7 https://t.co/474GpFKBo2

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Dr. John Cush RheumNow ( View Tweet)

FDA delays in the analysis of Pfizers/Xeljanz Oral Surveillance Safety study has put off potential approvals for other JAKs (Lillys Oluminant in Eczema & Abbvies Rinvoq for Eczema, Psoriatic arthritis, Ank Spondylitis). The wait continues.. https://t.co/3pRp2Vnuhw

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Dr. John Cush RheumNow ( View Tweet)

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