P65 Two-year efficacy and safety of mirikizumab following 104 weeks of continuous treatment: interim results from the LUCENT-3 open-label extension study
Why this work is in the frame
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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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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 it