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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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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FDA grants orphan drug designation to CAR T-cell therapy for systemic sclerosis https://t.co/KZKSy2sbNk https://t.co/5abz8MeYGK
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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
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French claims data study of Serious infections in 12K #PsA pts Rx w/ biologics (2015-2020) found 367 (3%) w/serious infxn (17/1000Pys). Compared to adalimumab, a signif. lower SIE risk was seen w/ ETN (HR 0.72), & ustekinumab (HR 0.57) https://t.co/oVomnKuYGJ https://t.co/y5DQatFoCa
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Expert Panel Guidance on Managing Psoriatic Arthritis and Comorbidities
An expert panel has published their consensus guidelines for the management of psoriatic arthritis (PsA) and it's comorbidities in the journal Rheumatology.
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Infection and Rituximab-linked Immunoglobulin Deficiency
A minority of immune-mediated inflammatory disease (IMID) patients treated with rituximab (RTX) are expected to develop and depressed immunoglobulin (Ig) levels. A recent cohort analysis suggests that RTX-induced Ig deficiency was not associated with an increased risk of severe
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JAK-pot: 46913 Rx courses on JAKi, TNFi, other MOA. Rx D/Cs for AEs:
- TNFi = JAKi (HR 1.0)
- Other MOA > JAKi (HR 1.11)
- TNFi < tofacitinib (0.81)
- TNFi > baricitinib (1.15)
- TNFi < JAKi; if >65yrs w/ CV risk (0.79) https://t.co/jCtLG3SNvP https://t.co/FN5U5Z1M9M
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Ides of March (3.15.2024)
Dr. Jack Cush has advice for Caesar and the superstitious, and covers pregnancy, platelets, dialysis and vaccinations in Lupus.
Dutch study of 586 RA pts on bDMARDs found more nonserious infections (NSIE) (77/100PYs) than serious infx (SIE)(1.3/100Pys). Upper respiratory
Long-term safety of Ixekizumab (IXE) - 26 RCTs (22k PYs) in PSO, PsA, AS & nr-axSpA
- nasopharyngitis most common AE; AEs did not incr over time
- D/C from AE 3-5/100Pys
- ISRs: 5.9-11.6/100PYs
- Candida 1.2-2/100PYs
- IBD: 0.1 PsO - 0.8/100PY for axSpA
https://t.co/nOoCE3VOxD https://t.co/F4gP1yR1Je
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