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Impact of regulatory warning on JAK inhibitors

Md Yuzaiful Md Yusof, MRCP(UK), PhD Jun 14, 2024

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?

more evidence in PsA - switch MOA rather than cycle within class failed first TNF @RheumNow #EULAR2024 https://t.co/hf2UB5MXEy

https://twitter.com/drpnash/status/1801508656623526235/photo/1

opposing point of view especially in males at 3 years !@RheumNow #EULAR2024 https://t.co/CXxIScQbFD

https://twitter.com/drpnash/status/1801509729711136816/photo/1

#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

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

#Behcet’s #syndrome is increasing in the UK ? ⬆️ Detection ? Changing population demographics ? Other reasons Poster discussion POS0258 #EULAR2024 @RheumNow @eular_org @Pr1yankaC https://t.co/SEzmJnFMhM

When would I use #Aclasta vs #Prolia since #denosumab has LESS #fractures ▶️younger women with #osteoporosis requiring Rx due to long safety ▶️less wearing off when stopping it ▶️noncompliant Pts as prolia reverses effect when dose is missed @RheumNow #EULAR2024 @eular_org https://t.co/0RTGx0sCTd

https://twitter.com/janetbirdope/status/1801588758711541852

Agree! Liz Volkmann said it straight Unsustainable RCTs in ILD trials in #scleroderma Why Can’t recruit ~same pool of early #dcSSc design RCT UNETHICAL a to have a progressing #scleroderma-ILD Pt on failed background #MMF + placebo for 1 yr 🙏🏻 #EULAR2024 @RheumNow @eular_org https://t.co/29oFEazwmM

https://twitter.com/Janetbirdope/status/1801594550097506713/photo/1

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

🗓️ Our abstract on psychosocial determinants of health in #RheumatoidArthritis will be presented at #EULAR2024 📹 Watch my video on @RheumNow for a sneak preview! 📍 Join me to hear more on #PARE Poster Tour IV, Friday 14th June, 12:00 - 13:00 CEST https://t.co/rDTJVukD6j

The Role of Psychosocial Determinants in the Management of Rheumatoid Arthritis

➡️POS0591 Are there sex differences in risk & outcomes of stroke in patients with #RA? 📈Stroke risk in RA increased compared to general population 🫀Not fully explained by traditional risk factors or AF 📊Stroke-related mortality differs in women vs men @RheumNow #EULAR2024

POS0592 Increased overall & cause-specific mortality in population-based cohort of people with incident #RA Higher mortality in RA vs gen pop but this has decreased after 2000 & better 10-year survival Severe causes of mortality incl cardiac higher in RA EULAR2024 @RheumNow

POS1035 FVC & risk of lung transplant & mortality in #RAILD 50% pts had FVC % predicted decline in ~6.5yrs 2/3 identified groups more strongly assoc w transplant or ILD-related death than INBUILD definition ➡️marked heterogeneity in ILD progression #EULAR2024 @RheumNow

#EULAR2024 POS1245 Healthcare Administrative Data in Italy showed despite prevalence of 3.8/10,000, heathcare cost in #Sjogren was 3 x higher than the general population due to active disease & comorbidities. Call for better MDT approach in management @RheumNow https://t.co/EevoT4jkqr

https://twitter.com/Yuz6Yusof/status/1801665949319283150/photo/1

important session worth reading the full recommendations - TNF tick of approval @RheumNow #EULAR2024 https://t.co/ORDocVie11

https://twitter.com/drpnash/status/1801664265461338298/photo/1

#EULAR2024 POS1420 A cohort study with 1/3 each with GCA, PMR and GCA+PMR found that at 6mth, 16% of patients had new diabetes/diabetes worsened. Worse in GCA+PMR group with the greatest GC accumulation. Call for better GC-sparing strategy @RheumNow https://t.co/ex7u83bVfj

https://twitter.com/Yuz6Yusof/status/1801662770636591394/photo/1

#EULAR2024 POS0742 A single cohort study showed for non-criteria #APS, cardiac manifestation (valvular dysfunction & regurgitation) was more common in Triple Ab+ vs Non-Triple Ab. We should monitor and consider an echocardiogram for this group of patient @RheumNow https://t.co/VxFUSpjaG1

https://twitter.com/Yuz6Yusof/status/1801658685774598633/photo/1

Active day of learning and discussion with a Round Up from Day 3 of #EULAR2024 with @RheumNow https://t.co/yzLsPNDM5d

https://twitter.com/synovialjoints/status/1801657394243518562/photo/1

#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

#EULAR2024 POS0024 Lymphopenia, anemia, & low Plt are assoc with disease activity & damage accrual in #lupus. Post-hoc analysis of RCTs + LTE showed Anifrolumab normalised these Haem parameters vs PBO. May improve fatigue-associated with anaemia @RheumNow https://t.co/GF8aKU0Z5x

https://twitter.com/Yuz6Yusof/status/1801654266823671968/photo/1

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Impact of regulatory warning on JAK inhibitors

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