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Upadacitinib: revisiting safety data in RA and GCA

Mrinalini Dey, MD

For the last several years, conversations about JAK inhibitors have often started and ended with safety. The shadow cast by ORAL Surveillance has made clinicians more cautious and regulators more restrictive.

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Nice to see a Dietary intervention study in the "Top Abstracts That Will Change My Practice in the Near Future" by L. Coates for Year in Preview Small RCT but fibres significantly improve response to treatment in the MTX treated RA group with a mean reduction of DAS28 of https://t.co/vMeIAK1P5u

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Aurelie Najm AurelieRheumo ( View Tweet)
Fukui et al. CorEvitas study. 12076 RA patients. Propensity score matching. Kidney dysfunction (eGFR<60) reduced chance of CDAI remission (HR 0.71) or remission/LDA (HR 0.88) @RheumNow #ACR25 Abstr#2640 https://t.co/uvTjOQlGD7

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Richard Conway RichardPAConway ( View Tweet)
Autologous CAR-Treg in RA, without any lymphodepletion preRx Early data from ph1, single dose Good initial response, stopped RA Rx, but some rebound Clearly work ongoing but excitement re: - CAR-Treg - RA as target dx - no lymphodepletion @minnakohlermd #ACR25 LB23 @RheumNow https://t.co/azmlFNU02R

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David Liew drdavidliew ( View Tweet)
REGULATE RA SBT-77-701 Engineered Treg cell in Refractory RA population 6patients Safety and tolerability: No DLT, CRS or ICANS Efficacy Reduction >50% in TJC and SJC 67% reduction of DAS-CRP >=2 stained up to wk 24 Impressive in pts for whom it works, yet a couple seem to https://t.co/lQAQABPhg0

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Aurelie Najm AurelieRheumo ( View Tweet)

Kohler et al. Phase 1 study autologous CAR-Tregs in refractory RA. No lymphodepletion needed! 6 participants. 2 doses, second cohort with higher dose better and more sustained response. No CRS or other toxicities. @RheumNow #ACR25 Abstr#LB023 https://t.co/nWva2R7WOQ

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Richard Conway RichardPAConway ( View Tweet)

#ACR25 Abstr#LB23 Phase 1 trial in 5 refractory #RA of SBT777101, a novel autologous CAR-Treg (without the need for lymphodepletion) showed promising efficacy and safety signal. No DLT, CRS or ICANS. Looking forward to larger data and in other RMDs @RheumNow https://t.co/YyGMSHjA3z

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Md Yuzaiful Md Yusof Yuz6Yusof ( View Tweet)
Effectiveness of b/tsDMARDs RA pts kidney dysfunction CorEvitas RA registry 9,569 pts Pts low eGFR = older more comorbidities less NSAIDs Reduced eGFR = 30% less likely to achieve remission Persists indeed of GC intake Is it a PK/PD related issue or somehow the reflection of https://t.co/KZuvPVa6eg

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Aurelie Najm AurelieRheumo ( View Tweet)
Cellular Biomarkers of Rheumatoid Arthritis https://t.co/mLYZRX9ypm Biomarkers of RA by @jeffsparks Lots of promising biomarkers, we need validation and hopefully translation to clinical practice. @RheumNow #ACR25

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Nouf Al hemmadi NoufAhmedAlham2 ( View Tweet)

Microbiome signature for prediction of response to MTX in RA: Yay or Nay? Microbiome analysis 60pts, 23 MTX NR BL enrichment in specific species in MTX NR Looking at the graphs though, seems to be driven by a few pts Prediction model doesn't seem to perform greatly Sens 88% https://t.co/1yrSXdE6DG

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Aurelie Najm AurelieRheumo ( View Tweet)

Regulate-RA study, first-in-human Phase 1 study data show citrullinated protein (CitP)-targeted CAR-Tregs (SBT777101) are safe and show early efficacy in refractory RA. 67% had ≥50% joint count reduction by Week 4. A novel, non-cytotoxic approach to immune modulation for https://t.co/g153w3XVEK

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Antoni Chan MD (Prof) synovialjoints ( View Tweet)
Ph2B RCT of Rosnilimab Tcell depleter (PD-1high Tph/Tfh, Teff) Wk 12 Primary Endpoint met Mean change DAS28-CRP at Wk 12 SC rosnilimab 100mg Q4W -2.06 400mg Q4W -2.12 600mg Q2W -2.06 PBO -1.69 >90% peripheral and synovial depletion pathogenic T cells 28 Wk Safety profile: https://t.co/XyVhJamFdp

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Aurelie Najm AurelieRheumo ( View Tweet)
Not all RA meds are equal for the heart. In >10K older adults w/ RA, advanced therapies lowered MACE risk (HR 0.63) vs csDMARDs, while GCs ↑ risk (HR 1.54) and undertreatment ↑ it 13-fold. Control inflammation, protect the heart. @RheumNow #ACR25 Abstract #2642

Jiha Lee JihaRheum ( View Tweet)

PD-1 agonist as an induction therapy in refractory RA?? Rosnilimab ph2b: - still responding 3mo after Rx stopped - no difference between type of prior b/tsDMARD failure - safety here looks good *so far* A lot of cautious excitement in the room for this #ACR25 LB19 @RheumNow https://t.co/CmfPlP4g0N

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David Liew drdavidliew ( View Tweet)
A new approach in RA: Rosnilimab targets & depletes PD-1–high pathogenic T cells, acting upstream of cytokine pathways. In Ph2b, all doses improved DAS28-CRP & ACR responses vs placebo, with durable efficacy & good safety. @RheumNow #ACR25 Abstract#LB19 https://t.co/cIxi7NEu6C

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Jiha Lee JihaRheum ( View Tweet)
#ACR25 Abstr#LB19 New T-cell therapy on the block! In Phase 2b RCT of #RA (~50% b/tsDMARD-IR), Rosnilimab, PD-1 agonist met its endpoint (DAS28-CRP) at WK12. Effective despite type of previous therapy. No safety concern/malignancy/death. To proceed to Phase 3 @RheumNow #ACRBest https://t.co/MecTYMpH0o

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Md Yuzaiful Md Yusof Yuz6Yusof ( View Tweet)
Emery et al. Rosnilimab, selective T cell (PD-1high Tph/Tfh, Teff) monoclonal antibody in RA. Phase 2 RCT. 424 patients. 41% prior bDMARD. 69% CDAI LDA week 14. Week 12 ACR20 70%, ACR50 40%, ACR70 21%. @RheumNow #ACR25 Abstr#LB19 https://t.co/479q6COWvk

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Richard Conway RichardPAConway ( View Tweet)
b/tsDMARD in RA + CKD (eGFR <60) From >12K pts in CorEvitas: - overall effective but 30% ↓ CDAI-emission (HR 0.71) - Findings consistent across TNFi, IL-6i, ABA BCDT, JAKi @RheumNow #ACR25 A#2640 https://t.co/UOP9ejZKoA

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Jiha Lee JihaRheum ( View Tweet)
Secrets and Pearls in Rheumatology https://t.co/SwnlB8UbHO @Janetbirdope pearls in rheumatology. Sero negative inflammatory arthritis ? Or is it? Look at the toes for early signs of PsA. In my clinic ITS inflammatory arthritis to determine etiology . @RheumNow #ACR25

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Nouf Al hemmadi NoufAhmedAlham2 ( View Tweet)

#ACR25 Abstr#LB15 Tell #RA patients on methotrexate that eating high fibre diet is good for them! An RCT showed improved EULAR response vs PBO. Likely due to restoration of Th17/Treg balance @RheumNow https://t.co/NbwQFqJNho

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Md Yuzaiful Md Yusof Yuz6Yusof ( View Tweet)
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