ANA Pollution (2.06.2026)
Dr. Jack Cush reviews the news, journal articles and regulatory news from this past week on RheumNow.com
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FDA sent a complete response letter to AstraZeneca on their application (BLA) for anifrolumabs (Saphnelo) subcutaneous use in SLE. Despite a positive TULIP-SC trial & EU approval of SC-anifrolumab, FDA & sponsor still have to work things out. CRL reasons are unknown https://t.co/3dNwEyolrj
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NEXT STEPS: Karp and investigators are engaged in the MONA LISA study - Using smile Data and biospeciments – they intend to look for biomarkers that may better predict the future development of SLE Dr. David Karp lecturing at UTSW @drdavidkarp @utswrheum https://t.co/acZD1kmNhq
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The challenge may be that lupus has multiple endotypes with variable rates of progression/trajectories. Can you Prevent SLE? Dr. David Karp lecturing at UTSW @drdavidkarp @utswrheum https://t.co/BA4KRKebIv
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SMILE enrollment hampered by COVID - yet failed to show a protective effect for HCQ in preventing SLE. Can you Prevent SLE? Dr. David Karp lecturing at UTSW @drdavidkarp @utswrheum https://t.co/GImHpycbgO
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REcently published SMILE study looked at the potential of HCQ (vs PBO) to prevent SLE in at risk people. Had to be ANA+ and 1-2 SLICC criteria at entry. Can you Prevent SLE? Dr. David Karp lecturing at UTSW @drdavidkarp @utswrheum https://t.co/4FY0kOLdRT
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Factors that may augment future development of SLE - includes Vitamin D levels, poor sleep, EBV reactivation & social determinants of health. Can you Prevent SLE? Dr. David Karp lecturing at UTSW @drdavidkarp @utswrheum https://t.co/e3TKATcxXB
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Only a subset of incomplete lupus (ILE) will progress to SLE - betw 1 in 10 and 1 in 5. Can you Prevent SLE? Dr. David Karp lecturing at UTSW @drdavidkarp @utswrheum https://t.co/oo40Dumk4I
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Can you Prevent SLE? Dr. David Karp lecturing at UTSW Showing that autoantibodies exist long before the onset of SLE @drdavidkarp @utswrheum https://t.co/zPAYbSlIBS
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FDA has announced "Breakthrough Designation" for 3 drugs + 1 test being developed:
** Biogen: litifilimab (targets dendritic cells) for cutaneous lupus
** Novartis: Ianalumab (BAFF blockade) for Sjogrens
** J&J: Nipocaiimab (FcRn) for Sjogrens
** Encarta: pocket Lyme test https://t.co/zODOTWyqP8
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Roche Canada announced that Health Canada has approved obinutuzumab (Gazyva) for the treatment of adult patients with active lupus nephritis who are receiving standard therapy. Following four initial doses in the first year, Gazyva can be administered twice yearly https://t.co/P4dCVkoPCH
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RheumNow Live Preview (1.30.2026)
Dr. Jack Cush reviews the news and journal reports from RheumNow.com - and the top 5 reasons to attend RheumNow Live 2026, which is one week away.
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Remission? Single center study of 100 RA, 100 SLE pts assessed by SLEDAI-2K, SDAI, VAS. Remission/LDA found in 88% of 392 SLE visits & 91% of 389 RA visits(p=NS). Remission was more common in SLE vs RA (79% vs 69%; p= 0.0018). https://t.co/ZPRrYQMsCT
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Japanese nationwide survey of 1943 RMD pts taking Azathioprine (AZA) 34% had adverse events: hepatobiliary (149%), GI (10%), blood/lymphatic (9%), infections (5%), & skin (2.4%). AEs lead to 71% D/C AZA. Serious AEs (Gr ≥3) higher w/ older (OR 2.5), & SLE (OR 2.3) https://t.co/lVNYVQATfx
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B Cells at the Brink in Sjögren Disease
The current issue of Arthritis & Rheumatology reviews current understanding of the immunopathogenesis of Sjögren disease (SjD) and how that has influenced the quest for drug development for this most systemic autoimmune disorder.
Although several new agents have shown very
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Lupus Foundation announced today that US House of Representatives have approved $27 Million in Funding for Lupus Programs in 2026 w/ fund available from (CDC), OMH, & DoD. Funding increased 40% @ CDC, 33% @OMH, & $415 million @ National Institutes of Health https://t.co/ENcykcW7yA
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Roche Canada announced that Health Canada has approved obinutuzumab (Gazyva) for the treatment of adult patients with active lupus nephritis who are receiving standard therapy. Following four initial doses in the first year, Gazyva can be administered twice yearly https://t.co/snAVErShjK
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Lupus Accelerating Breakthroughs Consortium commissioned a stakeholders group (including the FDA) to assess drug development in Cutaneous lupus CLE), and they have endorsed CLASI (CLE Dz Area & Severity Index) as the outcome measure for CLE clinical trials. https://t.co/q7If97AHBa
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New content online: Recommendations for the use of CLASI as an outcome measure in cutaneous lupus erythematosus clinical trials https://t.co/nDxfWWgutC https://t.co/Z6JMojdBz4
Links:
NatRevRheumatol @NatRevRheumatol( View Tweet )
Subcutaneous Anifrolumab in SLE
Manzi et al. have published the results of the TULIP-SC trial that showed that weekly subcutaneous (SC) anifrolumab, when given to severe SLE patients, had comparable efficacy and safety to the approved intravenous (IV) anifrolumab. https://t.co/EzaqS5q096
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Assess Reproductive Health in SLE Clinic Visits
Due to the complexity of SLE, rheumatology providers should take an active role in assessing reproductive health, providing education on how SLE may affect pregnancy, and taking a collaborative, multidisciplinary approach with the patient’s gynecologist.
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Emergencies, Independence & Hemorrhage (1.23.2026)
Dr. Jack Cush reviews the news and reports from the past two weeks on RheumNow.Com
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Congratulations to Lupus Research Alliance 2025 Global Science Award Recipients 1) Drs. Deepak Rao & Alexandra-Chloe Villani at Harvard affiliates; & 2) Dr. Caroline Jefferies at Cedars-Sinai. Grants will support interdisciplinary, collaborative, & synergistic projects in SLE https://t.co/GcfuEty75b
Dr. John Cush @RheumNow( View Tweet )
Subcutaneous Anifrolumab in SLE
Manzi et al. have published the results of the TULIP-SC trial that showed that weekly subcutaneous (SC) anifrolumab, when given to severe SLE patients, had comparable efficacy and safety to the approved intravenous (IV) anifrolumab. https://t.co/ruZM3Qftxb
Dr. John Cush @RheumNow( View Tweet )
A 2 yr. old female pt reported w/ a a novel P435S gain-of-function variant in TLR7 (thought pathogenic in SLE) - pt dx w/ juvenile SLE, recurrent infection, and neuroinflammatory features. A review of 12 other TLR7 GOF variants revealed similar SLE associations. https://t.co/NU553QwCtj
Dr. John Cush @RheumNow( View Tweet )
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The Impact of Obesity on Psoriatic Arthritis
Sponsored by Lilly Medical Affairs
Obesity is common in PsA and may worsen disease activity and reduce treatment effectiveness through shared inflammatory pathways. Weight intervention may improve outcomes and support achievement of targets of disease control.
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