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The future of lupus treatment is oral therapies?
There has been an explosion of trials in SLE, including nonrenal and glomerulonephritis studies. But, what about the JAKis and Tyk2 oral drugs in SLE?
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Promising new therapies in SLE
The pharmacology treatment in SLE is a rapidly expanding field of research that provides excitement and optimism to both the patients and the clinicians. We now have three licensed targeted therapies (belimumab and voclosporin in active lupus nephritis and anifrolumab in non-renal SLE) over the last 3 years compared to one therapy (belimumab in non-renal SLE) in the previous 50 years. What are other promising therapies on the horizon?
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An update on JAK inhibitors and cardiovascular risks
In the last 2 years, there has been more caution and vigilance with the use of JAK inhibitors in the treatment of rheumatoid arthritis due to the risk of CV events, including MACE and VTE. The ORAL surveillance study, a post-approval safety study conducted in RA patients aged ≥50 years with ≥1 CV risk factor, has resulted in increased caution and greater emphasis on assessment of MACE and VTE risks in patients starting JAK inhibitors.
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We worried that JAKi + MTX might impair Shingrix efficacy, esp given JAKi HZ risk
Shingrix nested in upa RCT:
Response (seroconversion rate, titres, cellular response) less than gen pop, but still very good
+ only 2/95 had RA flares
Vaccinate away!
OP0225 #EULAR2023 @RheumNow https://t.co/i4ObRSyYh9
David Liew drdavidliew ( View Tweet)
#EULAR2023 #POS1133 Consistent with clinical response in Phase 2 RCT, therapy with Updacitinib alone and ABV599-HD (Elsubrutinib + Upadacitinib) modulated IFN-I signalling pathways (IFN gene expression & proteomics). Assuring therapeutic evidence @RheumNowNews https://t.co/27mtCNg76X
Md Yuzaiful Md Yusof Yuz6Yusof ( View Tweet)
Can’t escape ORAL Surveillance RCT talk
Lots of real world data on CV risk & JAKi here
(with all the selection, measurement bias)
First up: multinational JAK-pot study (n=>50k)
Even if you mirror the high-risk RCT cohort - not much there for MACE
OP0219 #EULAR2023 @RheumNow https://t.co/FfNspdivri
David Liew drdavidliew ( View Tweet)
JAKi use did not increase CV risk compared to TNF, no difference between Bari and Tofa, non significant increased IRR in patients >65 years, Merel Opdam, Abst#OP0221 #EULAR2023 @RheumNow https://t.co/Pu5X8RHJOY
Dr. Antoni Chan synovialjoints ( View Tweet)
Malignancy in real world datasets:
do we see differences between DMARDs - particularly JAKi, with ORAL Surveillance in mind?
RABBIT German data (limited risk window):
Point estimates slightly up vs TNFi, esp in high CV risk pts
but magnitude not big
OP0218 #EULAR2023 @RheumNow https://t.co/Ou7TgWvf3b
David Liew drdavidliew ( View Tweet)
The JAK-pot study did not show any significant differences in MACE and other CV outcomes in RA patients treated with JAKi, slight increase signal in VTE/PE, Romain Aymon, Abst#OP0219 #EULAR2023 @RheumNow https://t.co/oPMnw2QmW3
Dr. Antoni Chan synovialjoints ( View Tweet)
#EULAR2023 #POS0112 Consistent with clinical response, Post-hoc analyses of Phase 2 RCT of Deucravacitinib (Tyk2-i) showed this therapy suppressed both IFN and B cell pathways - a broader mode of action in reducing #SLE pathophysiology. Look forward to Phase 3 results @RheumNow https://t.co/UoZ2xS3IzC
Md Yuzaiful Md Yusof Yuz6Yusof ( View Tweet)
JAK inhibitors have been effective in refractory inflammatory myositis, all open label, but no controlled trials. #EULAR2023
Dr. John Cush RheumNow ( View Tweet)
RheumNow’s expanded coverage of the #EULAR2023 annual meeting is sponsored in part by Bristol Myers Squibb. All content is chosen by RheumNow and its Faculty.
Dr. John Cush RheumNow ( View Tweet)
I’ve been hearing the term ´Jackies’ used in talks on Jak inhibitors. A shorter form of JAKinibs or JAKi #EULAR2023 @RheumNow
Dr. Antoni Chan synovialjoints ( View Tweet)
Don’t be ‘rash’, get adult immune compromised Pts vaccinated against #shingles #varicella #zoster K Winthrop has research re #HZ #vaccination with #Shingrix in #Upadacitinib at #EULAR2023 #OP0225 Bottom line-get #immunecompromised Pts with #rheumatoidarthritis jabbed! @RheumNow
Janet Pope Janetbirdope ( View Tweet)
JAKi have superior effectiveness at 6 months compared to TNFi and the efficacy was similar in those with and and without safety risk (increased age, CV risk, smoker) by Hannah Bower, Abst#0133 #EULAR2023 @RheumNow https://t.co/Pt6EoN6323
Dr. Antoni Chan synovialjoints ( View Tweet)
The overall risk of cancer and cardiovascular disease were decreased in RA treated with JAKi but there was no comparison with TNFi, Sung Soo Ahn, Abst#00132 #EULAR2023 @RheumNow https://t.co/9Bi6t6uuig
Dr. Antoni Chan synovialjoints ( View Tweet)
#EULAR2023 #OP0139 Should we aim for dual blockade in #lupus? A Phase 2 RCT showed more patients on ABBV-599 HD (elsubrutinib (BTK-i) + Upadacitinib (JAK-i)) and UPA monotherapy met primary & secondary endpoints vs Placebo at 48Wks. No major malignancy or VTE concerns @RheumNow https://t.co/HEUbkzZwyl
Md Yuzaiful Md Yusof Yuz6Yusof ( View Tweet)
JAKi are NOT associated w worse safety vs bDMARDs when adjusting for confounding. Did regulators get it wrong? #EULAR2023 @RheumNow #OP0116 https://t.co/ZNk0NI7Ky5
Janet Pope Janetbirdope ( View Tweet)
#JAKi May decrease #cancers - age, male, #diabetes had more #cancer but NOT associated w drug prescribed AND LESS #malignancy & LESS #CVE in JAKi vs csDMARDs in huge admin database. Diff from other results OP0140 @RheumNow #EULAR2023 EFFECTIVE Rx of RA LOWERS CVE & cancer w JAKi! https://t.co/oQ3QeUZz3E
Janet Pope Janetbirdope ( View Tweet)
Metanalysis of 62 RCTs, 16 LTEs, 82 366 Pt-Yrs JAK exposure. JAKi malignancy incid rate = 1.15/100 PYs in RCTs (1.26/100PYs overall). Network meta-analyses show no diff betw JAK & PBO or MTX in NMSC, but signif increased malignancy risk (IRR 1.50) https://t.co/kk12pa17Nn https://t.co/qEcRatKRSf
Links:
Dr. John Cush RheumNow ( View Tweet)
