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Dr. Jack Cush reviews the regulatory actions, news and journal reports from this past week on RheumNow.com.
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A systematic review suggests that traditional measures (serologies and disease activity) are superior to biomarkers in predicting response to biologics in systemic lupus erythematosus (SLE) patients.
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Misuse of laboratory testing may lead to misdiagnoses and mismanagement; this is particulary prevalent when clinicians consider the use of the diagnostic use of serological autoimmune markers.
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A phase 3 trial of obinutuzumab, an anti-CD20 monoclonal antibody, showed potent B-cell depletion and clinical efficacy active systemic lupus erythematosus without evidence of nephritis.
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About one in 18 patients taking hydroxychloroquine (HCQ) for 15 years develop retinal damage, a new meta-analysis indicated.
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Dr. Jack Cush reviews the news and journal reports from this week on RheumNow.com
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In the U.S, lupus nephritis affects approximately 40–50% of patients with systemic lupus erythematosus, contributing significantly to the morbidity and mortality of the affected individuals. However, significant differences in clinical approaches to lupus nephritis management still persist.
Dr. John Cush
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REVEAL, a 5-yr real-world study of 236 SLE pts initiating anifrolumab (basekbube SLEDAI-2K 7 for mucocutaneous (67%) & MSK (49%) dz. At 6 months, 26% achieved remission, 66% reached LLDAS, and 57% achieved LLDAS5. Authors claim rapid onset of action https://t.co/16OQatOcPj https://t.co/mU9aciCNcH
Dr. John Cush
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NEJM: Obinutuzumab in Active Systemic Lupus Erythematosus
A phase 3 trial of obinutuzumab, an anti-CD20 monoclonal antibody, showed potent B-cell depletion and clinical efficacy active systemic lupus erythematosus without evidence of nephritis.
https://t.co/OEuNAZlgzp https://t.co/yjUmJITAmQ
Dr. John Cush
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Prospective multinational cohort of 1180 lupus pts, followed ~2.7 yrs. 37% had renal biopsies (Class III/IV 56%). They achieved mCRR 46%, mPERR 53%, LLDAS 60%, & REMission 46% at least once. renal response highest @ 2 yrs. New organ damage 11% @ 1yr; 33% by 5yr. https://t.co/ugh60M08Xf
Dr. John Cush
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Hydralazine and the Rare Risk of Vasculitis
Since the 1980s, hydralazine has been a notable cause of drug-induced lupus, and inferred to cause vasculitis as well. A retrospective cohort study from Canada has shown that vasculitis resulting from hydralazine is possible, but https://t.co/ewqCesatbm
Dr. John Cush
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Urinary biomarkers improve w/ anifrolumab in TULIP-LN (lupus nephritis) trial; 112 pts, 197 uriniary proteins assessed. Urinary CD163 and MCP-1 signif improved as early as wk 12. Anifrolumab reduced the proteomic inflammatory signature, regardless of responder status https://t.co/n6fIJVDCN1
Dr. John Cush
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The Role of Calcineurin Inhibitors in Lupus Nephritis
In the U.S, lupus nephritis affects approximately 40–50% of patients with systemic lupus erythematosus (SLE), contributing significantly to the morbidity and mortality of the affected individuals (1). However, significant https://t.co/sc4cgAYzGy
Dr. John Cush
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NEJM: Obinutuzumab in Active Systemic Lupus Erythematosus
A phase 3 trial of obinutuzumab, an anti-CD20 monoclonal antibody, showed potent B-cell depletion and clinical efficacy active systemic lupus erythematosus without evidence of nephritis.
https://t.co/b5qHBotxbI https://t.co/dqzZodOokq
Dr. John Cush
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Update on FDA complete response letter to AZ regarding BLA hold for anifrolumab (Saphnelo) for SC use in SLE. CRL originally issued 10/10/25, but announced 2/3/26. FDA CRL cites critical data quality w/ key analyses in SC-TULIP study. A BLA decision expected in 1st half of 2026 https://t.co/zuwtsdL6I9
Dr. John Cush
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The Role of Calcineurin Inhibitors in Lupus Nephritis
In the U.S, lupus nephritis affects approximately 40–50% of patients with systemic lupus erythematosus (SLE), contributing significantly to the morbidity and mortality of the affected individuals (1). However, significant https://t.co/JBz0gQeJUr
Dr. John Cush
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Hydroxychloroquine Lowers SLE and RA Hospitalizations
A population-based study from British Columbia, Canada, shows that antimalarial adherence was associated with a lower risk of hospital admission in patients with rheumatoid arthritis (RA) and systemic lupus erythematosus https://t.co/vsJDOh09ji
Dr. John Cush
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Observational study of 42 Mexican lupus nephritis pts on Immunosuppressives + Calcineurin Inhibitors (CNIs) @ 12 mos complete & partial responses seen in 26% & 36%, w/ signif reduction in proteinuria (2.89 vs 0.72 g/d, p < .001), & transient decrease in eGFR at 12 mo (109 vs 114) https://t.co/Het4GKaTmv
Dr. John Cush
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Hydroxychloroquine Lowers SLE and RA Hospitalizations
A population-based study from British Columbia, Canada, shows that antimalarial adherence was associated with a lower risk of hospital admission in patients with rheumatoid arthritis (RA) and systemic lupus erythematosus https://t.co/YR8Zfw8pL6
Dr. John Cush
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FDA has granted Fast Track designation to J&Js nipocalimab for use in #SLE based on the results of a Phase 2b JASMINE study in which nipocalimab demonstrated reduction in lupus disease activity and potential for steroid sparing https://t.co/puQN6ecScj https://t.co/au422eamLR
