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Upadacitinib: revisiting safety data in RA and GCA
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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Should we be using JAKi more in female SpA patients?
In recent years, data has emerged suggesting that female patients with spondyloarthritis, both psoriatic arthritis and axial spondyloarthritis, may have worse outcomes than male patients. A number of post-hoc analyses of randomised controlled trials of both TNF inhibitors and IL-17 inhibitors suggest that this phenomenon is also manifested in the responses to these agents; female patients do less well than male patients. The mechanisms behind this remain to be fully elucidated.
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#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
Links:
Md Yuzaiful Md Yusof Yuz6Yusof ( View Tweet)
POETYK PsA 1 and 2 Deucravacitinib TYK2 inhibitor Ph3 RCT
52 wks data
Deucra 336pts PBO 334pts then crossover wk 16 to 52
Pooled analysis wk 16
ACR 20 54% vs. 31%
Enthesitis reduction LEI 52% vs. 45%
Dactylics resolution 58% vs. 44%
POETYK-PsA 1 Wk 52
ACR 20 63%
ACR50 44%
PASI https://t.co/LYJbU8fYwI
Links:
Aurelie Najm AurelieRheumo ( 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)
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
Antoni Chan MD (Prof) synovialjoints ( View Tweet)
Agrawal et al. Case study of tofacitinib + bDMARDs in refractory IA. 7 SpA, 2 RA, 1 JIA. Effective and safe. @RheumNow #ACR25 Abstr#2338 https://t.co/Y0B3W4csJX
Richard Conway RichardPAConway ( View Tweet)
#ACR25 Abstr#LB02 Is there a role for JAK-i for the treatment of IgG4-RD? Opel label RCT in China (N=58) showed NO relapse in Tofacitinib + GC taper vs GC Taper alone (54%). No serious infection. Interesting and a PBO-controlled is warranted @RheumNow https://t.co/dFvAmcGfCT
Md Yuzaiful Md Yusof Yuz6Yusof ( View Tweet)
When every option fails, bold moves remain.
In 5 multi-resistant RA pts, TNFi + JAKi combo brought remission in most without major AEs.
Not standard, not risk-free, but in young, low-infection-risk pts, it may offer a path forward.
@RheumNow #ACR25 Abstract#2272
Jiha Lee JihaRheum ( View Tweet)
To be continued (or discontinued?): Abstract 2360: Compared to TNFi, IL-17i & JAKi users had 🔹 Higher odds of med switching <180 days 🔹 Shorter time to discontinuation @RheumNow #ACR25 #axSpA https://t.co/IOHaFSJqHn
Akhil Sood MD, MS AkhilSoodMD ( View Tweet)
SELECT-COMPARE RA UPA vs. ADA
What do we learn from 7 years data? Not much
Patients who did well on the first drug, keep doing well
Patients who required switching for primary failure don't do as well, w/ 26% pts reaching DAS remission in UPA + MTX vs. 16% in ADA + MTX gp
No https://t.co/JLUTRZuZOm
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Aurelie Najm AurelieRheumo ( View Tweet)
~1 in 6 pts with #sarcoidosis May have #cardiac involvemt
1/3 respond to #MTX + #steroids
Followed by repeat #PET
Failures get
👇
#infliximab >#adalimumab
👇
#JAKi
Better survival >yrs ago
R heart involved ⬆️risk of MTX nonresponse
#ACR25 @RheumNow @ACRheum abst#1664 #ACRbest https://t.co/kYt9JRNSVH
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Janet Pope Janetbirdope ( View Tweet)
SELECT-COMPARE (upadacitinib vs adallimumab in mod-severe RA, no CV enrichment) 7y data:
safety profiles very similar, except for:
- zoster
- CK rise
- lymphopenia
- hepatic disorder
In the general RA population, no new JAKi safety signals
#ACR25 ABST1676 @RheumNow https://t.co/BA2JxONGfa
David Liew drdavidliew ( View Tweet)
Infection data from SELECT-GCA:
Glucocorticoids seem to drive overall infectious risk
UPA use associated with higher zoster - vaccinate!!
@RheumNow #ACR25 Abst# 0895 https://t.co/ueVbFPxG0Q
Brian Jaros, MD Dr_Brian_MD ( View Tweet)
Avouac et al. Lipid changes after JAKi initiation. 85 patients. Increases at 6 months. Largely appeared driven by HDL increase, and correlated CRP decrease. Appeared transient with return to baseline with time. @RheumNow #ACR25 Abstr#1333 https://t.co/CQ6u3ck1Ch
Richard Conway RichardPAConway ( View Tweet)
POETYK-PsA 1 & 2 Phase 3 RCT TYK2i Deucravacitinib
Pooled analysis 640+pts PBO vs. 640+pts DEUCRA 6mg QD
MDA 12% vs 22%
All elements of MDA response sig different except for Leeds enthesitis index
DAPSA Remission 2% vs. 9%
PsARC 42% vs. 61%
PASDAS -1 vs. -1.7
mCPDAI -1.2 vs. -1.9 https://t.co/OTOFxTOrRp
Links:
Aurelie Najm AurelieRheumo ( View Tweet)
Sex based differences in PsA proteomics
Analyse from POETYK PSA 1 & 2 deucravacitinib RCT
Large overlap but female pts specificities, Upregulation of:
-JAK STAT pathway
-Cytokine interaction
Linked with higher disease activity in female groups
Yes Correlation, but not https://t.co/VwiVOkxpoB
Links:
Aurelie Najm AurelieRheumo ( View Tweet)
#1627 SLR informing the 2025 @eular_org recommendations for PMR & LVV 🔍
141 studies (30 RCTs) reviewed: new & further evidence for IL-6, JAK & B-cell-targeted therapies. Data will underpin updated management guidance. @RheumNow #ACR25
Mrinalini Dey DrMiniDey ( View Tweet)
Real-world Indian cohort of 290 axSpA patients, generic tofacitinib achieved low/inactive disease in 89% after 25 months. Most adverse events were mild (e.g., transaminitis 14.5%) and manageable. No serious infections or MACE reported. A cost-effective alternative to bDMARDs in https://t.co/JBHfNq7kYt
Antoni Chan MD (Prof) synovialjoints ( View Tweet)
Real-world JAK persistence in RA is low: <30% at 2 years across Medicare & Marketscan data (n≈20K). Baricitinib lowest persistence; TOF & UPA slightly higher. Oral convenience hasn’t solved long-term adherence. Why? Safety, cost, access?
@RheumNow #ACR25 A#0369
Jiha Lee JihaRheum ( View Tweet)
