P65 Two-year efficacy and safety of mirikizumab following 104 weeks of continuous treatment: interim results from the LUCENT-3 open-label extension study
Bibliographic record
Abstract
<h3>Aim</h3> To evaluate long-term efficacy and safety of mirikizumab (miri), a p19-directed IL-23 antibody, in moderately to severely active ulcerative colitis (UC). <h3>Methods</h3> In LUCENT-3, patients received 200 mg miri Q4W subcutaneously. <h3>Results</h3> Among W52 miri responders (N=239), 74.5% demonstrated clinical response at W104. Remission rates at W104 for W52 clinical responders were 54.0% clinical, 52.7% corticosteroid-free (CSF), 65.3% endoscopic, 47.7% histologic-endoscopic mucosal remission (HEMR), 67.8% symptomatic, and 50.2% bowel urgency. Patients achieving histologic-endoscopic mucosal improvement (HEMI) and bowel urgency clinical meaningful improvement (CMI) at W104 were 53.1% and 67.0%, respectively. For W52 miri remitters, 76.6% demonstrated clinical response at W104. Remission rates at W104 for W52 clinical remitters (N=154) were 65.6% clinical, 64.3% CSF, 77.3% endoscopic, 59.1% HEMR, 74.0% symptomatic, and 51.3% bowel urgency. Patients achieving HEMI and bowel urgency CMI at W104 were 66.2% and 67.3%, respectively. Symptom score reductions from induction baseline at W52 were sustained through W104; W52 and W104 scores were respectively: stool frequency: -1.68, -1.79; rectal bleeding: -1.45, -1.45; bowel urgency: -4.03, -4.44; and abdominal pain: -3.74, -3.91. Severe TEAEs were reported in 4.5% of patients, while 5.2% experienced serious AEs, and 2.8% discontinued treatment due to an AE. Most common TEAEs (≥5%) were COVID-19 (12.1), colitis ulcerative (7.6), arthralgia (6.2), headache (6.2), nasopharyngitis (5.9). There were 0 deaths. AEs of interest were opportunistic infection (1.7%); cerebrocardiovascular event (0.7%); malignancy (0%); hepatic (2.1%); injection site reaction (5.5%). <h3>Conclusion</h3> These data support the long-term benefit of continuous miri treatment through W104 on clinical, endoscopic, histologic, and symptomatic endpoints, including biologic-failed patients, with no new safety signals identified or deaths reported.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| 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) | 0.002 | 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".