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Pharmacologic Efficacy in Still's Disease

A systematic review of the effectiveness and safety of pharmacological treatments for adult-onset Still’s disease (AOSD) supports the use of either IL-1 or IL-6 inhibitors.

A metanalysis was performed using databases, trial

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FDA has approved the adalimumab biosimilar Cyltezo (adalimumab-adbm) for the 2nd time, now as a high-concentration, citrate-free formulation for injection (from Boehringer Ingelheim) https://t.co/micTFhjgqm

Dr. John Cush @RheumNow( View Tweet )

🏆Dr. Georg Schett's pioneering work in CAR-T for #autoimmune disease has landed him among the TIME100 Most Influential People in Health “Not only are the patients in drug-free remission, but I believe many are cured of their autoimmune disease," he said https://t.co/Rj7FpkluNg

Healio Rheumatology @HealioRheum( View Tweet )

CAR T-Cell Therapy in Autoimmune Disease | New England Journal of Medicine https://t.co/VKlNGVDfyw. - persistence of CAR-T cells needs exploration

Peter Nash @drpnash( View Tweet )

With the FDA's approval of its 50th biosimilar - they have published "A Milestone in Facilitating the Development of Safe and Effective Biosimilars". Since biosimialrs were approved in 2015, they saved the health care system $23.6 billion. https://t.co/7GPJ5XLGnr https://t.co/6Qw7DttmjT
Dr. John Cush @RheumNow( View Tweet )

Rheum Chapter Notes (4.26.2024)

Dr. Jack Cush reviews this past week’s news and journal articles from RheumNow.com.

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50 active RA pts RCT Rx w. either low dose IL-2(n=26), IL-2+TCZ (9) or control (15). All improved clinically by DAS28-ESR, but IL-2 Rx pts had signif proliferation of Tregs, w. decr inTh1, Th2, & Th17 cells. TREG #s correlated w/ ESR drop (r=0.54) https://t.co/1tF63FuXzx https://t.co/M5TWsa6zI4
Dr. John Cush @RheumNow( View Tweet )
Dawn of CAR-T cell therapy in autoimmune diseases - A review article from the Chinese Medical Journal https://t.co/Qbort9Rsmh https://t.co/wWwTXkZiXj
Dr. John Cush @RheumNow( View Tweet )
AbbVie announced preliminary positive results from phase 3 SELECT-GCA study showing remission in 46% of #GCA pts Rx w/ upadacitinib for 52wks (vs 29% PBO); RCT included a 26-wk steroid taper regimen https://t.co/DIstJ4hazo https://t.co/VXc7rj0REJ
Dr. John Cush @RheumNow( View Tweet )

Canary in a Coal Mine (4.19.2024)

Dr. Jack Cush reviews regulatory reports, news and novel journal articles - this week focusing on Sjogren's, ILD, Gout and Uveitis.

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FDA has approved a ustekinumab biosimilar (ustekinumab-aekn; AKA Selardsi), made by Teva & Alvotech, for the treatment of moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA) in both adults and pediatric pts.https://t.co/ZXvFjjH7Qt https://t.co/7FJKxSVAgL
Dr. John Cush @RheumNow( View Tweet )

Lupus Accelerating Breakthroughs Consortium Partners with FDA

EurekAlert!

The Lupus Research Alliance (LRA), founder and administrator of the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), announced today at the Consortium’s first anniversary meeting an expanded partnership with the U.S. Food and Drug Administration (FDA) with the inclusion of the Center

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PNAS: Autoimmunity against MDA5 induces fibrotic ILD in mice. In this murine model of dermatomyositis, treatment with either anti-CD4 or anti-IL-6 receptor antibody ameliorated the MDA5-induced fibrotic ILD. https://t.co/CahyGfTn4g https://t.co/lfpdgEvGmx
Dr. John Cush @RheumNow( View Tweet )
IL-1 recept accessory protein (IL1RAP) shown to block mediators (IL-1, IL33, IL36) that may drive systemic sclerosis. In vitro, IL1RAP inhibited fibroblasts and endothelial cells; in mouse models of SSc anti-IL1RAP decr dermal & pulmonary fibrosis. https://t.co/6YE02P4rjR https://t.co/mzw7t88Jzl
Dr. John Cush @RheumNow( View Tweet )
This study examined the risk of neuroinflammatory disease after initiation of b/tsDMARDs Overall risk of neuroinflammatory events among new users of TNF inhibitors did not differ substantially as compared to new users of other b/tsDMARDs In AC&R https://t.co/8rGgZmpq9c https://t.co/5gxuWBctBL
ACR_Journals @ACR_Journals( View Tweet )

ICYMI: Sex Disparities in PsA/SpA

Dr. Eder delivered an illuminating talk at RheumNow Live 2024 on sex differences in psoriatic arthritis; the disease may manifest differently in men and women, and therapeutic responses may differ between the sexes.

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JAMA: SLE Review

Drs. Caroline Siegel and Lisa Sammaritano (from HSS in NYC) have published an impressive overview of systemic lupus erythematosus (SLE) in JAMA. This timely, well-written review covers the many complexities of this multi-organ disorder that affects nearly 3.4 million people worldwide.

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FDA Curriculum and Toolkit on Biosimilars for educators; Fact sheets on: - Biologicals, Biosimilars & InterchangeableProducts - Generics & Biosimilars - Manufacturing & Variation - Biosimilar Regulatory Approval Pathway https://t.co/bHYFPb8VxU https://t.co/bA8I567H8U
Dr. John Cush @RheumNow( View Tweet )
Research on SGLT2 inhibitors in #gout is needed. They have been shown to reduce uric acid & gout flares, and may be uricosuric or be antiinflammatory. Also decreased incident gout (by half) among at-risk patients with type 2 diabetes (HR 0.54) https://t.co/CGG9aFsgoD https://t.co/5O2f3MFL8C
Dr. John Cush @RheumNow( View Tweet )
Cabaletta Bio announced FDA has granted Orphan Drug Designation to CABA-201, a 4-1BB-containing human CD19-CAR T cell agent, to treat systemic sclerosis. RESET (REstoring SElf-Tolerance) trial program includes the Phase 1/2 RESET-SSc trial https://t.co/Vo5jIHBrPj https://t.co/TXvFypbZdw
Dr. John Cush @RheumNow( View Tweet )
BIOBADASER registry 1128 RA pts Rx w/ 1st ts/bDMARD, Among the 9.3% w. multimorbidity they noted higher DAS28 dz activity, but no differences in ts/bDMARD retention rates betw those w/ and without multimorbidity https://t.co/hZDpceuOFq https://t.co/pxSg6rKNNr
Dr. John Cush @RheumNow( View Tweet )
FDA grants orphan drug designation to CAR T-cell therapy for systemic sclerosis https://t.co/KZKSy2sbNk https://t.co/5abz8MeYGK
Dr. John Cush @RheumNow( View Tweet )

Naysayers & Disrupters (3.22.2024)

Dr. Jack Cush reviews the news and journal reports from the past week - including a few contrary reports on infection, seropositivity and plasmapheresis.

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2023 EULAR Psoriatic Arthritis Recommendations

EULAR has updated its treatment recommendations from the prior 2019 guidelines, since which there have been several newly developed agents. The updated guidance includes 7 overarching principles and 11 recommendations regarding treatment strategy and pharmacological therapies.

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Stills pts w/ remission on Tocilizumab who stop TCZ, 50% will relapse in 1 yr. Lower relapse rate w/ longer TCZ use w/ prednisolone lowering. 38/48 AOSD Rx w/ TCZ were in remission after 6 mos. & 12 D/C TCZ - half flared after mean of 5.5 mos.https://t.co/L9XbUX8lXn https://t.co/Z4oixQR2oX
Dr. John Cush @RheumNow( View Tweet )