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Impact of regulatory warning on JAK inhibitors
The development of JAK inhibitors represents an advance for the treatment of inflammatory rheumatic diseases. However, the enthusiasm in using this target has waned since the publication of the ORAL surveillance clinical trial in 2022. Subsequently, both the FDA and EMA issued a warning on using JAKi in patients with certain risk factors, e.g., ≥65 years, at increased risk of MACE, current smoker or past smoker and at increased risk of cancer, should other alternative treatment be available. So, how has this warning impacted on JAKi development and use?
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EULAR 2024 – Day 2 Report (A Difficult RA Day)
Day 2 at EULAR 2024 was a big poster day for many with several good sessions and oral presentations on Preventing RA, new vasculitis therapies and a session devoted to the 50th anniversary of the Moll & Wright Criteria.
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lets put this bed now @RheumNow #EULAR https://t.co/r0SVoOk47O
Peter Nash drpnash ( View Tweet)
THE ASSOCIATION BETWEEN DEPRESSION AND BIOLOGIC PRESCRIBING IN AXIAL SPONDYLOARTHRITIS (axSpA): LESSONS FROM AN IRISH axSpA COHORT more likely to have peripheral arthritis enthesitis psoriasis - shoukd we be formally assessing eg Beck’s DI @RheumNow #EULAR2024
Peter Nash drpnash ( View Tweet)
#EULAR2024 LBA0001 New Steroid-sparring therapy for #GCA. Phase 3 RCT showed Upadacitinib 15mg met primary endpoint (sustained clin remission frm Wks 12-52 & adherence to 26Wk GC taper) vs PBO [46% vs 29%] & multiple secondary endpoints. No new safety signals @RheumNow https://t.co/edfSZkMuy2
Md Yuzaiful Md Yusof Yuz6Yusof ( View Tweet)
LBA0001 UPA in GCA- Phase 2 RCT
15mg UPA with 26w steroid taper showed
⬆️ efficacy
⬇️ steroid use
vs placebo with 52w steroid taper
Potential new target on the horizon for #GCA??
@RheumNow #EULAR2024
Mrinalini Dey DrMiniDey ( View Tweet)
POS0231 Safety of JAKi vs TNFi or IL-17 inhibitors in #PsA & #SpA
Results from a large population-based study show reassuring data, with no increased risk of #CVD, #VTE or certain cancers compared to TNFi or IL-17i
@SteZhao @RheumNow #EULAR2024
Mrinalini Dey DrMiniDey ( View Tweet)
1200 PsA pts 6 countries IL17is as effective as TNFi and JAK despite more failed bDMARDs and monotherapy & faster onset action than IL23s @RheumNow #EULAR2024 https://t.co/SM5CA7KUvd
Peter Nash drpnash ( View Tweet)
Do we need more IL-17 and JAK Inhibitors in Spondyloarthritis?
Dr. Eric Ruderman shares his perspectives on the following abstracts being presented at #EULAR2024 in Vienna, Austria:
OP0195
LBA0005
POS0803
OP0138
https://t.co/MnefRxYqMh https://t.co/Mwq4s7eTKY
Dr. John Cush RheumNow ( View Tweet)
Potential efficacy of JAK inhibitors in VEXAS syndrome
#EULAR2024
NZ https://t.co/HziLUgo1gA
Annals of the Rheumatic Diseases ARD_BMJ ( View Tweet)
EFFICACY AND SAFETY OUTCOMES OF TAK-279, A SELECTIVE ORAL TYROSINE KINASE 2 (TYK2) INHIBITOR, FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2B TRIAL IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS - smells tastes & looks like a Tyk2 - acne signal? @rheumnow #EULAR2024
Peter Nash drpnash ( View Tweet)
#wasup in #GCA?
#upadacitinib +RCT in #temporal #arteritis LBA0001
Residual #inflammation in 1/3 of pts at 6 mo #Rx w #TCZ on repeat TA Bx
OP0621
#PMR cases
#Leflunomide beats #MTX for
#pred sparing
⬇️relapses
But MTX dose was low
POS0280
#EULAR2024 @RheumNow @eular_org
Janet Pope Janetbirdope ( View Tweet)
New #JAKi #disease #results
#Baricitinib in #alopecia #areata esp 4mg/d
#Upadacitinib in Crohn’s
#Upa in #polyarticular #JIA & kid #PsA
+RCT of UPA in #GCA
Awaiting results of #SLE
With #deucravicitinib & UPA #RCTs
#EULAR2024 @eular_org @RheumNow
Janet Pope Janetbirdope ( View Tweet)
I think if we’re worried about JAK inhibitor safety, we need to be doing it right.
I wrote this for @RheumNow for #EULAR2024 ahead of my debate against @Janetbirdope, but also drew my inspiration from @RADoctor in @ACR_Journals - a must read:
https://t.co/RA6ktQAzqO https://t.co/lltDbtxpAg
Links:
David Liew drdavidliew ( View Tweet)
#EULAR2024 Please find my short blog on the Impact of Safety Warning Update on the use of JAK-inhibitors @RheumNow
https://t.co/Z4pujQRQ9h https://t.co/QRUnJInblH
Links:
Md Yuzaiful Md Yusof Yuz6Yusof ( View Tweet)
#EULAR2024 POS0390 What impact of regulatory warning on JAK-i on access to therapy? Data from UK BSSR-BR reported 4 in 5 #RA patients would have been considered ‘high-risk’. Of these, 28% had failed ≥3 biologics; so no suitable alternatives. Enormously impacted @RheumNow https://t.co/XeS9qHXSpH
Md Yuzaiful Md Yusof Yuz6Yusof ( View Tweet)
#opportunistic inf in #autoimmune dz
🎤 @khyrich
👉#herpes zost is ⬆️⬆️,esp😳#lupus (💉 >18yo🇺🇸)
👉#HBV react ⬆️⬆️ w/ RTX (9.1%) >>TNFi, JAKi, IL-6
👉 🙅♂️ #TB repeat 🧪 on #DMARD if 🚫new risk fact/gap⚠️
🔗#eular 2022 guide:
https://t.co/PIpGpTrH28
#eular2024
#rheumx
@RheumNow https://t.co/kouXvradiC
Links:
- https://ard.bmj.com/content/annrheumdis/82/6/742.full.pdf
- https://twitter.com/AMinalyan/status/1801606024576565284/photo/1
- https://twitter.com/AMinalyan/status/1801606024576565284/photo/1
- https://twitter.com/AMinalyan/status/1801606024576565284/photo/1
- https://twitter.com/AMinalyan/status/1801606024576565284/photo/1
Artem Minalyan, MD, DABOM AMinalyan ( View Tweet)
The art of talking about risks with our patients
https://t.co/V0JQ1EsbKc https://t.co/GSTbPu0EXZ
Dr. John Cush RheumNow ( View Tweet)
Having said that, the EMA warning has elements making it extremely tough:
- still very broad criteria that capture 80% of people who were starting JAKi
- the need for "no suitable treatment alternatives" before using a JAKi, right across all diseases (not just RA) 3/ #EULAR2024 https://t.co/IsrYO7qzqM
Links:
David Liew drdavidliew ( View Tweet)
TYK2i RCT 290 pts 12 wks in active PSA
TAK-279 15mg 30 mg 53% 54% vs PBO 29%
ACR 50 15mg 30 mg 26% 26% vs. PBO 10%response PASI 75 30 mg 46% vs. 15m 28% PBO 15%
Safety profile acceptable
Abstr#OP0138 #EULAR2024 @RheumNow https://t.co/thNuwvUgQp
Aurelie Najm AurelieRheumo ( View Tweet)
