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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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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)
Sex differences in 💊 d/c in axSpA from the RISE registry 🔅Females - ⬆️discontinuation risks for TNFi 🔅No sex differences seen in dc risks for IL17i and JAKis 🔅Young females discontinued faster than males Gender diff in SpA can guide tx decisions #ACR25 @RheumNow Abs2634 https://t.co/kcXfZrU4zI

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sheila RHEUMarampa ( View Tweet)
We often see patients with MTX lab abnormalities but How frequent is MTX toxicity? Retrospective study 2500pts Rochester Epidemiology Project cohort 60% w/ ever lab abnormalities, but 4% attributed to MTX 0.87/100 patient year Organ injury event 0.02/100 patient year = 5 in https://t.co/w8oYUjj5Yp

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Aurelie Najm AurelieRheumo ( View Tweet)
Head to head study of Secukinumab vs Ustekinumab. In TNFi-experienced PsA patients, the AgAIN trial shows secukinumab performed better than ustekinumab in HAQ-DI response (57.1% vs 27.0%, p=0.002) and across all endpoints (joint counts, pain, and skin outcomes). Fewer https://t.co/CDCWkLF5TW

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Antoni Chan MD (Prof) synovialjoints ( View Tweet)
Abstract 2360: Single-center lupus pregnancy cohort found that: 🔹 Absence of DORIS remission associated w/ adverse pregnancy outcomes (Pre-term, Pre-eclampsia) 🔹 This is along with known risk factors: antihypertensive use, prior nephritis, active disease @RheumNow #ACR25 https://t.co/STg1NBeFPo

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Akhil Sood MD, MS AkhilSoodMD ( View Tweet)
In a retrospective TrinetX analysis of 3 year safety outcome in AS, JAKi use was linked to higher mortality and GI bleeding vs TNFi, but lower malignancy risk. Infection rates were similar, with a trend toward more herpes zoster in JAKi users. Abstract#2633 @RheumNow #ACR25 https://t.co/pPY0wpAKA3

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Antoni Chan MD (Prof) synovialjoints ( View Tweet)
DMARD exposure overall during pregnancy is not associated with severe maternal or neonatal morbidity, in this Ontario cohort. We’re getting better at finding a balance with DMARDs that is safe for both mother and baby. Blanket resistance is harmful #ACR25 ABST2627 @RheumNow https://t.co/oDOpySGS3N

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David Liew drdavidliew ( View Tweet)
Predictors of retinopathy progression after HCQ discontinued? In the chart review of 28 pt records who had retinopathy, 35% progressed despite d/c Age - significant assoc'n with progression ✳️monitor toxicity more closely esp in older pts #ACR25 @RheumNow Abs2444 https://t.co/9rf2RQAgRQ

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sheila RHEUMarampa ( View Tweet)
A new IA drug in OA 🚨 Cell therapy of apoptotic PBMCs ENX-CL-05-001 RCT Ph2A moderate to severe OA 134 pts 3 injections vs. PBO Pain improvement 24% Better response in people > 60 and more so 65yo Potential improvement for > 6mo Safety mainly local reactions to compound https://t.co/m2MZN3i22b

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Aurelie Najm AurelieRheumo ( View Tweet)
Post-hoc analysis of CARE study comparing effect of Cenerimod 4mg vs. PBO Mos. 4-6: >10% improvement in alopecia w/Cenerimod Mos. 2-6: >10% improvement in mucosal ulcers w/ Cenerimod Early improvement in alopecia & ulcers w/Cenerimod Promising? #ACR25 @RheumNow Abs2440 https://t.co/mAqmIQashr

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sheila RHEUMarampa ( View Tweet)
52wks data of IZOKIPEB affibody IL17Ai RCT 2b/3 PsA Primary ACR 50 16wks Crossover 52 wks IZO 160 Q2W, IZO 160 QW, PBO-> IZO 160 QW ACR50 50% 57% 51% ACR70 36% 42% 42% PASI100 55% 64% 58% MDA 47% 52% 47% No specific enthesitis data presented No new safety signal Next https://t.co/J18rSTmyze

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Aurelie Najm AurelieRheumo ( View Tweet)
#1748 Higher air pollution, esp PM2.5, linked to ⬆️RA disease activity and more flares in >1000 Korean patients. Each rise in PM2.5 significantly boosted DAS28, CDAI & joint counts. Does cleaner air mean calmer joints? @RheumNow #ACR25

Mrinalini Dey DrMiniDey ( View Tweet)

There’s all sorts of products out there. Who knows, ‘Reuma King’ or ‘Contra Reumas’ might do something, but that’s probably all the fraudulent hidden dexamethasone inside… Beware+++ #ACR25 FDA Update @RheumNow https://t.co/rco4wTXBjO

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David Liew drdavidliew ( View Tweet)
US Electronic Health Record cohort 2000+pts Incidence Heart Failure over 10 yrs 6.8% HF asso w/ Older Male Lower eGFR Hypertensive medication Diabetes TTMTS MTX, TNFi Higher CRP Probably surrogates for High Disease Activity... How do we detect it? Maybe not by using the https://t.co/s9SjEyk3WF

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Aurelie Najm AurelieRheumo ( View Tweet)
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