P0580 Efficacy and safety results of tulisokibart re-induction treatment in participants with ulcerative colitis in the Phase 2 ARTEMIS-UC clinical trial
Bibliographic record
Abstract
Abstract Background Tulisokibart is a monoclonal antibody that targets tumor necrosis factor-like cytokine 1A (TL1A), a regulator of inflammation and fibrosis in inflammatory bowel disorders such as ulcerative colitis (UC). The Phase 2 ARTEMIS-UC study demonstrated a significantly higher proportion of tulisokibart vs. placebo participants achieving clinical remission after 12 weeks of treatment1. This analysis evaluates the effects of re-induction treatment in participants who were non-responders during the initial 12-week induction period of the study. Methods Participants (≥18 years) of moderate to severe active UC, with conventional or advanced treatment failure, were randomized (1:1 ratio) to placebo or the 12-week induction treatment (intravenous tulisokibart 1000 mg, Day 1 and 500 mg, Weeks 2, 6, and 10). The study population consisted of 2 cohorts based on a genetic diagnostic test (Dx) assessing likelihood for responding to anti-TL1A treatment. Cohort 1 included participants stratified by Dx results while Cohort 2 included only Dx positive participants. Cohort 1 is the population used in these post-hoc analyses evaluating induction non-responders. Induction non-responders in either the tulisokibart or placebo groups were assigned to an open label 12-week re-induction with aforementioned induction dosing regimen (non-responders are defined as participants who did not achieve reduction of ≥2 points and ≥30% in modified Mayo score from baseline, accompanied by a reduction ≥1 in rectal bleeding sub score or absolute rectal bleeding sub score ≤1 at week 12). Efficacy and safety were assessed following the re-induction treatment at Week 26. Results In Cohort 1, 67 and 68 participants were randomized to receive placebo or tulisokibart induction treatment, respectively. At Week 14, 41 (placebo) and 21 (tulisokibart) induction non-responders entered re-induction and received 12-week open label tulisokibart treatment. At Week 26, 48% and 63% of participants who received initial 12-week of tulisokibart treatment (total 24-week tulisokibart treatment) and 63% and 76% of participants who received initial 12-week placebo treatment (total 12-week tulisokibart treatment) achieved symptomatic improvement and symptomatic response, respectively (Table). Re-induction with tulisokibart was well tolerated with no serious AEs or discontinuations due to AEs and no new safety signals (Table). Conclusion Re-induction treatment with tulisokibart is effective in participants who did not respond to initial induction treatment. Additionally, up to two tulisokibart induction regimens totaling 24 weeks is well tolerated with no new safety signals identified. References 1.Sands et al. N Engl J Med 2024; 26;391(12):1119-1129
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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 | 0.003 | 0.003 |
| 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 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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".