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Drug Safety

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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Long term safety of bimekizumab (BKZ) in ankylosing spondylitis (BE AGILE) study (n 296) shows sustained ASAS40 efficacy @wk 48 (52%) & wk256 (50%). Low AE for candidiasis (2.6%), SIE (1.4%), IBD (0.8/100PY), Uveitis (0.7/100PY) Abst# POS0215 #EULAR2024 https://t.co/9PWey3itu9
Dr. John Cush @RheumNow( View Tweet )
I was allocated to bring down the warning, & I did apologise up front to both the EMA and Janet #EULAR2024. It's a tough gig regulating impactful medicines with risk-benefit, especially when our world is full of other medicines with risk-benefit trade-offs (like prednisolone). 2/ https://t.co/6YPhYHbhg8
David Liew @drdavidliew( View Tweet )
So how do we get from slightly increased numbers of uncommon events in a single study (ORAL Surveillance)? Regulators think differently to us, which partly is the difficulty of a restrictive warning. So being the Aussie I am, I asked - does it pass the 'pub test'? 4/ #EULAR2024 https://t.co/Ih9H87wH22
David Liew @drdavidliew( 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
David Liew @drdavidliew( View Tweet )
Here's my 'pub test' for whether the warning is appropriate. And, debate aside, I do believe that it behoves any regulator to consider the unintended consequences of their regulation, because regulation has real consequences. 5/ #EULAR2024 https://t.co/aurbAwgl9P
David Liew @drdavidliew( View Tweet )

Can we withdraw treatment in post-menopausal osteoporosis?

EurekAlert!

Analysis of French claims data, found over half of women initiating oral bisphosphonates (BP) between 2015 and 2020 discontinued treatment for at least one year, which was associated with a 12% increase in fracture risk. While not recommended, 42.5% of women initiating Dmab discontinued

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“One way to get rid of TDM is to get more drugs, and that’s what we’re doing” - Gertjan Wolbink, the godfather of rheumatology therapeutic drug monitoring (TDM) #EULAR2024 @RheumNow https://t.co/SYM8hjMMPJ
David Liew @drdavidliew( View Tweet )
In the ‘why therapeutic drug monitoring’ debate, we’ve heard a lot about TDM utility, but the con argument is interesting. Desiree van der Heijde compares TDM to IL-6 levels, which never displaced her DAS then puts up some confronting points. Interesting #EULAR2024 @RheumNow https://t.co/7zomungi3e
David Liew @drdavidliew( View Tweet )

EULAR 2024 - Day 1 Report

Wednesday was Day One at EULAR 2024 in Vienna. While the day was a slow start, the poster halls and auditoriums quickly filled with thousands of rheumatologists, eager to reunite at this international educational forum. Below are a few of my favorites from Day 1.

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AMPLIFIED RCT, 300+ pts ABA NOT (!) superior to ADA in dual seropositive SE+ MTX IR RA pts ACR50 rate high in both gps ABA 59% vs ADA 64% No new safety signal Defeating the encouraging data from smaller trials Abstr#OP0007 #EULAR2024 @RheumNow https://t.co/PvRUnpthHl
Aurelie Najm @AurelieRheumo( View Tweet )
I chaired great debate at #EULAR2025 - JAK Inhibitor Special Warnings: can observational data debunk an RCT? Drs Janet Pope(NO) vs David Liew(YES). Voting suggests most are concerned about JAK warnings, but Liew won by converting a minority his way @janetbirdope @Drdavidliew https://t.co/bV1JdO7c4e
Dr. John Cush @RheumNow( View Tweet )
EULAR 2024 kicked off with a fantastic debate between Janet Pope and David Liew - ‘JAK inhibitor special warnings: Can observational data debunk an RCT?’ A thought-provoking discussion summarising all aspects of the ongoing conversation on JAKi use in high-risk patients! https://t.co/MzW3jSSCfr
The Immune-Mediated Inflammatory Disease Forum @IMIDforum( View Tweet )
More data from Jak-pot, the real-world multinational RA study, this time looking at infection in 14 national registries JAKi (vs TNFi) had no signal for general/serious infection (excluding HZ) Somewhat reassuring post-ORAL Surveillance infection data #EULAR2024 OP0092 @RheumNow https://t.co/ocAbc4NiV2
David Liew @drdavidliew( View Tweet )
OP0053 #EULAR2024 @RheumNow #EULARBest Effect of #RTX in preclinical #RheumatoidArthritis RA-risk pts given 1 dose PBO or 1000mg RTX RTX in RA-risk pts delayed onset of RA by 1yr; no benefit on QoL Pts developing RA: RTX didn't alter PROs or disease severity when developing RA

Mrinalini Dey @DrMiniDey( View Tweet )

Shingrix in upadacitinib + MTX RA, in SELECT-COMPARE RCT: data now out to 60w good humoral and cellular response in most, even without MTX withheld (& good safety too) Important for our JAKi-treated patients to get the protection they need #EULAR2024 OP0020 @RheumNow https://t.co/FqVCCwUJOg
David Liew @drdavidliew( View Tweet )
@Janetbirdope @RheumNow #EULAR2024 JAK-i Debate @drdavidliew (NOT in support of regulation) - is the signal real? Query about replicability & data came from N. America. Not reflected on real-world data of enriched cohorts - is the warning justified? - are there unintended consequences? @RheumNow https://t.co/TXUf90fqwN
Md Yuzaiful Md Yusof @Yuz6Yusof( View Tweet )
Asking the quintessential Australian question at #EULAR24 by @drdavidliew - does the ORAL surveillance study for JAKi *truly* pass the pub test? @eular_org @Janetbirdope @RheumNow What does #MedTwitter think? https://t.co/bqwPU8XX5S
Benjamin Sutu @benjaminsutu( View Tweet )
#EULAR2024 JAK-i Debate. @Janetbirdope [Pro Regulatory Safety Measures] - to do no harm esp since there are other alternatives - supported by RCT - although JAK-i have different structures, data from individual RCT + LTE showed similar rates of malignancy & MACE @RheumNow https://t.co/jQKQmHE9Fg
Md Yuzaiful Md Yusof @Yuz6Yusof( View Tweet )

The art of talking about risks with our patients

On the first day of EULAR 2024, I am debating Janet Pope. To make it more challenging, it’s about JAK inhibitor safety, and I have been allocated to argue against the regulatory safety warning and

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Is Cannabis Safe? (6.7.2024)

Dr. Jack Cush reviews FDA approval, news and journal articles -- and it’s the week before EULAR 2024 in Vienna!!

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Cannabis Use is Common, But is it Safe?

Two current JAMA reports suggest that cannabis use is not only common, but that if heavily used may increase mortality rates.

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JAK or TNF Inhibitor as First Drug for Rheumatoid Arthritis?

Medpage Today

A Janus kinase (JAK) inhibitor outperformed tumor necrosis factor (TNF) blockers for substantially reducing rheumatoid arthritis (RA) symptoms in patients for whom conventional anti-rheumatic drugs had failed, a pragmatic head-to-head trial found.

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Boxed Warnings in Derm: - Topical Calcineurin inhib (atopic dermatitis): rare risk of cancer - IL-17 Inhibitors (PSO, PsA): exacerbation of IBD (38 RCTs: only 12/16,690 new IBD case - Psoriasis and suicidality: suicide risk same w/ or without treatments https://t.co/HsjO78NtjP https://t.co/v9Pys8RwcH
Dr. John Cush @RheumNow( View Tweet )