Pharma/Regulatory

Publication Discussion: A Phase 3 Trial of a JAKi in Patients With Giant Cell Arteritis Listen as Dr. Rubbert-Roth discusses Phase 3 efficacy and safety outcomes of a JAKi in patients with GCA. Sponsored by AbbVie Medical Affairs + Health Impact. https://t.co/odjx0cmODQ https://t.co/1NrI2WcKYY

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Complex Evolution of RA Management and Outcomes FIRST is a Japanese longitudinal, real-world registry of rheumatoid arthritis (RA) management, and over the last 20 years has shown significantly improved outcomes, yet significant challenges and unmet needs remain. https://t.co/TwDIf5MJqF
Dr. John Cush @RheumNow( View Tweet )
FDA has approved nipocalimab (Imaavytm), a FcRn for use in generalized myasthenia gravis (gMG). It is approved for using in gMG patents who are anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older. https://t.co/CaSwCnCK8V https://t.co/A2COjk2hzY

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EULAR Guidelines on Reproductive Health Rheumatology patients considering or actually having babies can safely take most of the medications currently used to treat their conditions, according to an updated guideline from the European Alliance of Associations for Rheumatology https://t.co/121I7Yb8Ki
Dr. John Cush @RheumNow( View Tweet )
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Keys to Mastery (5.2.2025)

Jack Cush, MD

Dr. Jack Cush reviews the news, articles and drug approvals from the past week on RheumNow.com. This podcast marks the beginning of our Lupus Campaign called "Lupus Unlocked: Keys to Mastery". This month's campaign on Lupus is sponsored by Aurinia.

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FDA Approves Rinvoq for Giant Cell Arteritis Based on the results of the SELECT-GCA study, the US FDA has approved upadacitinib (Rinvoq or UPA) for the treatment of adults with giant cell arteritis (GCA), also known as temporal arteritis. This is the 9th FDA approved indication https://t.co/gPTwnR2VLw
Dr. John Cush @RheumNow( View Tweet )
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EULAR Guidelines on Reproductive Health

MedPage Today

Rheumatology patients considering or actually having babies can safely take most of the medications currently used to treat their conditions, according to an updated guideline from the European Alliance of Associations for Rheumatology (EULAR).

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US- Top Drug Rx Sales in 2024 Semaglutide $54 Billion Tirzepatide $31.7 B Adalimumab $28B Apixaban $26 B Empagliflozin $20.5 B Pembrolizumab $18 B Ustekinumab $17 B Risankizumab $16 B Dupilumab $15.6 B Etanercept $10.1 B Secukinumab $7.7 B Immune globulin $7.1 B Upadacitinib $7 https://t.co/Wjcu7LrTfC
Dr. John Cush @RheumNow( View Tweet )
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FDA Approves Rinvoq for Giant Cell Arteritis

Jack Cush, MD

Based on the results of the SELECT-GCA study, the US FDA has approved upadacitinib (Rinvoq or UPA) for the treatment of adults with giant cell arteritis (GCA), also known as temporal arteritis. This is the 9th FDA approved indication for upadacitinib in the U.S. for use in rheumatology,

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U.S. healthcare pharmaceutical spending reached $805.9 billion in 2024, a 10.2% increase from 2023 https://t.co/Aq7utEJ8sK https://t.co/zgEPppe6Oe

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2024 Management of Familial Mediterranean Fever Recommendations

Jack Cush, MD

A EULAR/PReS combined task force has developed recommendations for the management of Familial Mediterranean fever (FMF), the most common monogenic autoinflammatory disease worldwide. These evidence-based recommendations update the 2016 recommendations developed for rheumatologists and other HCPs

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Better Responses with Chronotherapy for Baricitinib A nonrandomized, open-label, controlled trial has shown superior efficacy when baricitinib was given at night (instead of day); attesting to the benefits of chronotherapy - selective dosing meant to target the body's diurnal https://t.co/jSrPdoOpmo
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Pairwise Network Metanalysis suggests that JAKi use may NOT be assoc w/ Gastrointestinal perforation (GIP), as suggested by the PI. 23 RCTs, (20,023 pts) followed for 24 wks. Incidence of JAKi GIP=0.19%. compared to csDMARDs this was not signif increased (RR 1.02; CI: 0.41-2.56). https://t.co/lLD9Tj6a9F
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Rheumatology: Believe It or Not (4/25/2025)

Jack Cush, MD

Dr. Jack Cush reviews the news and journal reports from the past week on RheumNow.com. Should we believe the reviews and metanalyses?

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A review of 18 guideline recommendations on DMARDs in pregnancy & reproductive health. There were recs. DMARDs & pre-conception (56%), lactation (67%), male fertility (33%), & use of csDMARDs (72%), bDMARDs(72%), tsDMARDs (28%); less recs for b/tsDMARD use https://t.co/tKGCXrbOuc
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Unmet Needs in Still’s disease

Jack Cush, MD

In February 2023, an expert consensus panel of pediatric and adult rheumatologists met to address challenges in Still’s disease (SD), including systemic juvenile idiopathic arthritis and adult-onset SD. They addressed four main topics: (1) early recognition and diagnosis of SD; (2) pathogenetic

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Retrospective EGPA study of mepolizumab Rx 45 pts Rx initially w/ 300 mg/4 weeks, 27% switched to 100 mg/4 wks after 26 mos & 50% maintained complete remission without GC. Other half had sinonasal Sxs Rx w/ increased MEP dose orlocal therapy. https://t.co/H8ftg136Ez https://t.co/CKchbGpq20

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Dr. John Cush @RheumNow( View Tweet )
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Better Responses with Chronotherapy for Baricitinib

Jack Cush, MD

A nonrandomized, open-label, controlled trial has shown superior efficacy when baricitinib was given at night (instead of day); attesting to the benefits of chronotherapy - selective dosing meant to target the body's diurnal variations.

Chronotherapy implies that we may selectively

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Piperacillin effectively treats Lyme disease at 100-times lower dose than doxycycline https://t.co/NQXG7FRtwh https://t.co/YcIYJqorKX https://t.co/e7UCG0z4wL

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An emulation trial shows that Humira biosimilars (Amjevita & Imraldi) were equivalent to Humira in psoriasis & achieving PASI <=2, both for new biologic starts and for biologic switchers. https://t.co/8lTGGs2rbP https://t.co/T6rTJ5ESj2

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CDC's Committee on Immunization (ACIP) met and recommended: 1. Expand strains for meningococcal vax 2. Lower age for RSV vax > 50y 3. Rec. chikungunya vax for certain travelers - Flu & Covid Vax to be up next mtg 6/25 https://t.co/jInnR5JSxS https://t.co/PXg0HDLgnL https://t.co/Vro5mbjG9R

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Dr. John Cush @RheumNow( View Tweet )
If you see women with inflammatory arthritis who are pregnant or planning a pregnancy, the MAMA Study may be recruiting at an obstetric unit near you. To find out what is happening, visit @TheMAMAStudy, https://t.co/N8B5MpTsRx, or email mama@npeu.ox.ac.uk. @NPEU_CTU @NPEU_Oxford https://t.co/lQdgUiZ0Cb

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ACR & Arthritis Foundation Denounce the Dismantling of Vital Health Programs

Arthritis Foundation and ACR

As organizations representing nearly 60 million adults and children living with arthritis in the United States and the rheumatologists and health care professionals who treat them, we are deeply alarmed by this week’s dismantling of multiple branches of the Centers for Disease Control and

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Retrospective EGPA study of mepolizumab Rx 45 pts Rx initially w/ 300 mg/4 weeks, 27% switched to 100 mg/4 wks after 26 mos & 50% maintained complete remission without GC. Other half had sinonasal Sxs Rx w/ increased MEP dose orlocal therapy. https://t.co/M4Gp52QdwQ https://t.co/zb13fuKhpH

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Dr. John Cush @RheumNow( View Tweet )
The Increasing Cost of First-Line Biologics for Plaque Psoriasis A national commercial claims analysis of first-line use of biologics in biologic−naive plaque psoriasis patients found a near doubling of net treatment costs from 2007 to 2021 ($21 236 to $47 125). Despite the https://t.co/mWXz2o0mwz
Dr. John Cush @RheumNow( View Tweet )

Recent Blogs

Choice Overload (and the Way Out)

Jack Cush, MD
paint,choice,overload,color
I recently overheard a very good practicing rheumatologist complain, “why do I need yet another drug for psoriatic arthritis? I have more treatment choices than I have actual PsA patients who need a new or better drug”. Read Post

Best of 2022: Methotrexate in PsA

Philip Mease, MD
Methotrexate
Until the publication of the SEAM trial, evidence in the medical literature for the efficacy of the most commonly used drug for psoriatic arthritis worldwide, methotrexate, has been lukewarm at best. Yet we all employ it commonly, either as monotherapy or in combination with biologic or targeted synthetic DMARD treatment. It is inexpensive and widely available, and only modestly toxic. Read Post
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