Drug Safety
David Liew drdavidliew
1 year 3 months ago
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
1 year 3 months ago
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
1 year 3 months ago
So I think there is plenty we could do instead.
better regulation
better risk stratification
better counselling
better risk factor management
(and definitely read this if you want to be a good clinician: https://t.co/RA6ktQB7gm)
18/ #EULAR2024 https://t.co/bC5nmi8SoM
- The Art of Communicating Risk and Benefit to Promote Shared Decision‐Making, In…
- https://twitter.com/drdavidliew/status/1801144689774735739/photo/1
- https://twitter.com/drdavidliew/status/1801144689774735739/photo/1
- https://twitter.com/drdavidliew/status/1801144689774735739/photo/1
- https://twitter.com/drdavidliew/status/1801144689774735739/photo/1
David Liew drdavidliew
1 year 3 months ago
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
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 treatment for at least one year, which almost doubled their fracture risk. No increased risk was observed for long term discontinuation of IV BP.
David Liew drdavidliew
1 year 3 months ago
“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
1 year 3 months ago
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
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.
Aurelie Najm AurelieRheumo
1 year 3 months ago
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
Dr. John Cush RheumNow
1 year 3 months ago
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
The Immune-Mediated Inflammatory Disease Forum IMIDforum
1 year 3 months ago
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
David Liew drdavidliew
1 year 3 months ago
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
Mrinalini Dey DrMiniDey
1 year 3 months ago
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
David Liew drdavidliew
1 year 3 months ago
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
Poster Hall