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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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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)
Turns out you can directly degrade NETs. Holy smokes NETs critical in pathology of SLE & other dx They’ve found you can target it Enzymatic degrader fused to albumin Proof-of-concept: degraded a patient’s SLE manifestations in hours Definitely one to watch #ACR25 LB22 @RheumNow https://t.co/HVEt8wFYmI

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David Liew drdavidliew ( 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)

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)

#ACR25 Abstr#LB20 At EULAR, data for Phase 3 RCT of Deucravacitinib, Tyk2-i in active #PsA showed ACR20 was met at WK16. Here, data showed sustained response through WK 52 across core domains inc. those who switched PBO->DEU. No major safety assoc. with JAK-i.A few acne @RheumNow https://t.co/tmzQMOtjev

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Md Yuzaiful Md Yusof Yuz6Yusof ( View Tweet)
In POETYK PsA-1, deucravacitinib showed sustained efficacy through Week 52 in PsA, improving joint, skin, PROs, and radiographic progression. Safety remained favorable with no new signals. TYK2 inhibition continues to show promise. Abstract#LB20 @RheumNow #ACR25 https://t.co/sGkk062HqJ

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Antoni Chan MD (Prof) synovialjoints ( View Tweet)
Questions #ACR25 LB20 to Paul Emery on rosnilimab: Fleischmann: could be induction therapy? (Not intent, but could be) Choy: Depth of changes with translational data Tanaka: Safety given peresolimab ph2b here (diff epitope, membrane proximity, targeted depletion PD-1hi) @RheumNow

David Liew drdavidliew ( View Tweet)

Mease et al. 52 week results deucravacitinib in PsA. Approx ACR20 60%, ACR50 40%, ACR70 25%. Sustained radiographic benefit. No new safety signals @RheumNow #ACR25 Abstr#LB20 https://t.co/vKqjb08mI8

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Richard Conway RichardPAConway ( 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)

#ACR25 Abstr#LB14 Promising therapy BMS-986353, a CD19 CAR-T in Severe Refractory Idiopathic Inflammatory Myopathies. 11/12 had evaluable data; muscle, skin and ILD improved. 1 x G2 CRS, 1 G3 ICANS. Longer FU needed and larger sample @RheumNow https://t.co/zAG23tAsbL

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Md Yuzaiful Md Yusof Yuz6Yusof ( View Tweet)
Cohort study comparing 3yr safety outcomes of JAKi vs. TNFi in AS pts JAKi use: ⬆️incidence of HZ infxn but not significant; ⬆️all-cause mortality (HR 4.94) and GI bleed (p=0.04) Individualize tx. consider potential complications #ACR25 @RheumNow Abs2633 https://t.co/pjKAazQFwW

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sheila RHEUMarampa ( View Tweet)
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