Long-term efficacy and safety of tulisokibart in participants with ulcerative colitis: the open-label extension of the phase 2 ARTEMIS-UC study
Bibliographic record
Abstract
Introduction: Tumor necrosis factor–like cytokine 1A (TL1A) is a regulator of inflammation and fibrosis in inflammatory bowel disease. Tulisokibart, an anti-TL1A monoclonal antibody, demonstrated efficacy without clinically meaningful safety findings vs placebo after a 12-week induction in adults with moderately to severely active UC in the multicenter, double-blind, placebo-controlled phase 2 ARTEMIS-UC study. [ 1 ] Objectives: We report long-term efficacy and safety of tulisokibart among cohort 1 induction responders at week 50from the OLE period of ARTEMIS-UC ([ Fig. 1 ]). Fig. 1 Methodology: Participants were enrolled into 2 cohorts based on a genetic diagnostic test (Dx): cohort 1 (Dx-positive and negative) and cohort 2 (Dx-positive only; not reported here). Induction dosing was intravenous (IV) tulisokibart 1000 mg (day 1) and 500 mg (weeks 2, 6, and 10) or placebo. At week 14, induction responders (reduction of≥2 points and≥30% in modified Mayo score [mMS] from baseline, and reduction≥1 in rectal bleeding subscore or absolute rectal bleeding subscore≤1 at week 12) were randomized (stratified by Dx status) to open-label IV tulisokibart 100 mg or 250 mg every 4 weeks. We report clinical, endoscopy, biomarker, and safety outcomes up to week 50 for cohort 1 tulisokibart induction responders. Efficacy outcomes include clinical remission, endoscopic improvement, and fecal calprotectin. Results: Tulisokibart induction responders (47/68) were randomized to tulisokibart 100 mg (n=22) or 250 mg (n=25). Clinical, endoscopic, and biomarker outcomes are shown in the Table. In the safety population, (tulisokibart 100 mg, n=30; 250 mg, n=35), adverse events (AEs) occurred in 77% and 63% of participants, respectively; most were mild to moderate in severity. Serious AEs occurred in 3% and 7% of patients in the 100 mg and 250 mg groups, respectively. Conclusion: At week 50, maintenance of treatment efficacy was generally observed in cohort 1 induction responders in the tulisokibart group. A trend for higher efficacy with tulisokibart 250 mg vs 100 mg maintenance treatment was observed at week 50. Tulisokibart was well tolerated with no identified safety signals. Publication History Article published online: 04 September 2025 © 2025. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".