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lupus SLE

Tyk2 Inhibition Effective in SLE

Nov 28, 2022

Deucravacitinib, an oral, selective TYK2 inhibitor, has demonstrated efficacy in a phase II trial active systemic lupus erythematosus (SLE) patients.

The results of this phase II trial were recently presented at ACR 2022. This  phase II multinational trial enrolled 363 adults with

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Retrospective study looked at 47 adults w/ dermatomyositis treated with tofacitinib. While clinically similar, those on TOFA were were younger (53vs 61), shorter Rx duration (24 vs 53 mos);there was signif CDASI improvement. #ACR22
Do oral JAKs in atopic dermatitis cause VTE? Meta-analysis (15 RCTs, 466 993 pts) does NOT show increased risk of VTE associated with AD & JAK inhibitors (HR 0.95) w/ low VTE incidence (0.05%) w/ JAKi and (0.03%) placebo.
JAKi Regulatory Decisions - FDA, EMA, Canada New download available!
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ACR 2022 Appraisal, Praise & Critique (11.18.2022)

Nov 18, 2022

It was great to be back at an ACR annual meeting, this one in Philadelphia - Philly was great. A walking town, rich in culture, history and good places to meet and mingle. 

I loved the city, but not the convention center (not easy to navigate). 

The meeting itself was very

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Maya Buch on major adverse CV events in tofa vs TNFi. Post-hoc analysis of phase 3b/4 data looking at cohort enriched for CV events. @RheumNow #ACR22 #LateBreaking
L06 #ACR22 ORAL Surveillance Updates! Composite of all ischemic CV events and HF did NOT show difference b/w TOFA vs TNFi But, MACE numerically higher with Tofa w/ h/o ASCVD Highest CV risk in TOFA 10 mg BID, 2/2 VTE risk Most important risk is pt's individual risks @RheumNow
Does tofacitinib work better in patients with PsA and AS who smoke? Abstract #1036 #ACR22 @RheumNow 🚬519 ever smokers 🚭767 never smokers 💉In PsA only, TOF efficacy was greater in ever smokers vs. PBO ✋Overall, efficacy was generally comparable in ever v. never 🚬
Post-hoc analysis of SELECT-COMPARE showing decreased residual pain at week 12 but not week 26 cf. ADA, regardless of residual inflammation. Does this just reflect differing onset of action? @RheumNow ABST0297 #ACR22
Fleischmann et al. Safety of TYK2i Deucravacitinib in PsA/PsO in terms of labs. Really no effect on lab values other than increase in trigs. Guess this is why they don't have lab monitoring on label? @RheumNow #ACR22 Abstr#2132
Warren et al. TYK2i deucravacitinib in plaque psoriasis at 2 years. Sustained efficacy. No new safety signals seen. @RheumNow #ACR22 Abstr#2134
New SLE Rx. Deucravitinib a TYK2i phase 2 RCT showed SRI4 endpoint. Subset of 3 mg bid was best vs 6 mg bid and 12 mg OD. Skin via CLASI-50 & other endpoints also positive. Awaiting phase III. Abst1117 #ACR22 @RheumNow
Is #Tofacitinib an option in #PMR poly myalgia rheumatica? RCT of Tofa 5 mg bid vs prednisone 15 mg/d and tapering. Equal results. Needs a phase 3 trial but could be an option if needing to avoid prednisone ex osteoporosis, DM, etc. abst#1107 #ACR22 @RheumNow
Kavanaugh et al. TYK2i deucravacitinib in PsA. Nice breakdown of MDA and its components over 16 weeks. MDA achieved 23-24% with deucravacitinib at 16 weeks vs 8% with placebo @RheumNow #ACR22 Abstr#2136
Mease et al. TYK2i Deucravacitinib in PsA. Phase 2 RCT 52 week results. PASDAS, DAPSA efficacy maintained through week 52. No new safety concerns. @RheumNow #ACR22 Abstr#1598
In RA pts initiating their first b/tsDMARD, Abs 1420 did not observe differences in 6- and 12-month effectiveness outcomes between ETN, ADA, and JAKi monotherapy. #ACR22 @RheumNow
Pike et al. Deucravactinib (TYK2i) in SLE. + on SRI(4) week 32. + SRI(4),BICLA, LLDAS, CLASI-50, swollen and tender joint counts week 48. Strange, the lowest dose (3mg bd) seems best. @RheumNow #ACR22 Abstr#1117 #ACRbest
TOFA and MTX: which one to withdraw first? RCT in 100+ RA pts in remission after 1 yr, 1 yr follow-up Withdraw MTX grp: Remission 30% LDA 40% Withdraw TOFA grp: Remission 50% LDA 65% diff NS small sample 8 SAEs, 72% recovery #ACR22 @Rheumnow
#abst2132 #acr22 @rheumnow safety of Deucravacitinib Ph2PsA&ph3PSO trial: no Δ from BL in hematology, chemistry, or lipid labs. JAK 1/2/3 Effects on hem, hepatic, CPK, and cholesterol lab parameters not observed over 16 wks of DEUC at doses up to 12 mg QD & in combo w/csDMARDs.
Plenary: Tyrosine kinase 2 (TYK2) ◦ Mediates signaling of Type I IFNs, IL-23, and IL-12 ◦ Key cytokines involved in lupus pathogenesis ◦ Deucravacitinib oral TYK2 inhibitor ◦ Phase 2 RCT in SLE showed efficacy Pike M Abs1117 #ACR22 @RheumNow
Phase 2 efficacy and safety of deucravaticinib (TYK2i) in mod-severe SLE. Met primary endpoint (SRI4) for 3mg and 6mg doses (but not 12mg). No signal for HZ but increased oral herpes. Bigger numbers will be helpful. @RheumNow #ACR22 #plenary #ACRBest
Fascinating Abs 0653 #ACR22 In vitro models show JAKis counteract celluar cytotoxicity of HCQ in a human retinal pigment epithelial cell line and podocytes. Possible new way to dec. retinopathy/nephropathy? @RheumNow
Ab1117 #ACR22 Deucravacitinib: TYK2 inhibitor in active SLE? 363 pt P2, double-blind PBO-controlled 48 wk study DEUC 3 mg BID, 6 BID, 12 QB vs PBO: At 32wk: DEUC 3BID & 6BID > PBO, sustained across all groups at 48wk. AEs: similar bw PBO and DEUC. No VTE @RheumNow #ACRBest
Tofa 5 mg BID successful in treating refractory uveitis in reducing inflammation and reducing steroid dosage. Abs 1041 #ACR22 @RheumNow
Kahlenberg @Kahlenberglab et al. TYK2i deucravacitinib in SLE. Clinical efficacy (figure). Deucravacitinib suppressed IFN production, IFN-responsive gene expression, IFN-inducible proteins, B cell markers,serological biomarkers. @RheumNow #ACR22 Abstr#1000