Don’t miss this 🧵 on anti-TL1A for #IBD#UC#Crohns!
We review the available data of the 3️⃣ upcoming agents for this 🆕 exciting MOA ! @DCharabaty@vipuljairath 👇🏽👇🏽👇🏽
1/ #MondayNightIBD#Back2Basics
TL1A , a 🆕🎯for inflammation & ?fibrosis
3️⃣anti-TL1A mAbs w/ Ph 2 trials data +active Ph 3 for #UC & #Crohns
⚙️MOA, efficacy, safety
🆓CME 👉🏼mnibd.short.gy/TL1AsTW
Support by an educational grant @Sanofi
📍Where are you in your career?
1/ #MondayNightIBD#Back2Basics
TL1A , a 🆕🎯for inflammation & ?fibrosis
3️⃣anti-TL1A mAbs w/ Ph 2 trials data +active Ph 3 for #UC & #Crohns
⚙️MOA, efficacy, safety
🆓CME 👉🏼mnibd.short.gy/TL1AsTW
Support by an educational grant @Sanofi
📍Where are you in your career?
2/ #MondayNightIBD
🚧~40% mod-sev #IBD have no or LoR to current Rx
🎯TL1A: TNF superfamily member, binds DR3 on T cells, NK cells & ILCs
🥊Drives inflammation (Th1/Th17/Th2) AND fibrosis (fibroblast activation)
🥊anti-TL1A block TL1A–DR3 →⬇️innate + adaptive immunity
7/ DUVA safety (RELIEVE UCCD Wk14)
🚫No⬆️ TEAE signal DUVA vs PBO
🚫No dose-dependent signal
🚫No deaths, CA, MACE, VTE
🧬ADAs low; no neutralizing antibodies
⚠️1 anaphylactic rxn (450mg CD); resolved
📌10 SAEs in 450mg CD arm in 1pt w/ severe COVID, judged unrelated to DUVA
8/ #MondayNightIBD
🎬Next: Tulisokibart
Phase2️⃣trials
🏹ARTEMIS-UC (UC)
🎻APOLLO-CD (CD)
💉TULI 1,000mg IV wk0, then 500mg IV wk 2, 6, 10
OLE: Wk12 responders: 🔀randomized 250 or 100mg IV Tuli Q4W
10/#MondayNightIBD
ARTEMIS-UC OLE
OLE study:
TULI Wk 12 responders 🔀 250 vs 100mg IV TULI Q4W
Outcomes at Wk50:
🩺Clinical remission: 48%/32%
🔦Endo response: 48%/36%
🆑Disease clearance (symptomatic+mucosal remission): 44%/32%
12/ TULI safety (ARTEMIS-UC + APOLLO-CD)
🚫No ⬆️AEs signals Tuli vs PBO
🚫No deaths, infusion rxns, serious infections
🧬ADAs low, no impact on efficacy
⚠️1 Bowen's disease — related per investigator, unrelated per sponsor
13/ 🎬Finally, Afimkibart
🌻TUSCANY-2 (Ph2b, UC) RCT
💉Induction AFIM SC 50/150/450mg Q4W through Wk 14 vs PBO
→Treat through to wk56 w one of 3 AFIM doses Q4W
🎯Primary endpt: clinical remission tMS 2 or less
*Afim Ph2 data is UC-only; no CD trial data reported yet
14/ #MondayNightIBD
TUSCANY-2: Wk14 induction AFIM in UC
🩺Clin Rem by mMS:
450 mg: 32% (Δ +20% vs PBO)
150 mg: 35% (Δ +23%)
50 mg: 30% (Δ +18%)
PBO: 12%
⚠️Endpoint did not reach statistical significance per tMS, but meaningful improvemt by mMS & ⬇️ in FCP across all doses
16/ #MondayNightIBD
TUSCANY-2 in UC wk56 data:
Same-dose clinical remission (mMS) from wk 14 to wk56
450mg: 29% →36%
150mg: 38% → 39%
50mg: 30% → 31%
🩺Remission was sustained across all doses w modest gain at highest dose
18/ #MondayNightIBD
🔥Anti-TL1A-Exciting 🆕 MOA
🧘🏽♀️RELIEVE-UCCD/DUVA
🏹ARTEMIS-UC & 🎻APPOLO-CD/TULI
🌻TUSCANY(UC)/AFIM
✅Meaningful induction efficacy
✅Efficacy maintained at 1yr
✅👌🏽 Safety, no class 🚩
✅Low immunogenicity
💬What are you mostly excited about for this MOA?