P321 Mucosal Healing and Clinical remission after Treatment with Adalimumab in Small Intestinal Crohn’s Disease (SIMCHA study): final results from a prospective, open-label, single-arm study
Bibliographic record
Abstract
Abstract Background Endoscopic mucosal healing is a key treatment target in inflammatory bowel disease (IBD). The aim of this study was to investigate small bowel (SB) mucosal healing using video capsule endoscopy (VCE) in patients with Crohn’s disease (CD) following, 24 weeks of adalimumab therapy. Methods In this prospective study, moderate to severe SB involvement CD patients were enrolled, defined by a Lewis score on VCE at diagnosis >, 790 in at least one tertile. All patients were treated with adalimumab monotherapy at the standard dosing for CD for, 24 weeks prior to undertaking the follow-up second VCE. The primary outcome was the endoscopic healing defined as a Lewis score (LS) <, 350, whereas partial response was defined as a >, 50% decrease from baseline in LS. Secondary outcomes included the remission in the clinical symptoms (Harvey Bradshaw Index, HBI <, 4) and biomarkers (fecal calprotectin, FC <, 200 ug/g, and c-reactive protein, CRP <, 5 mg/l). Results A total of, 59 CD patients were screened at McGill University Health Centre between November, 2011 and October, 2021;, 15 patients were met the eligibility criteria and were enrolled. The median age at inclusion was, 46 years (IQR, 28–51), 8 patients (53.3%) had ankylosing spondylitis. The most frequent locations of CD on VCE findings were the proximal-mid ileum (93.3%) and jejunum (73.3%). Primary outcome; complete endoscopic healing was observed in, 8 patients (53.3%, p=0.002, OR for remission = 2.14, 95%CI:, 1.25–3.68), and partial response in an additional, 5 patients (33.3%) after, 24 weeks. The median total Lewis score was decreased significantly compared to the baseline (1,912 vs., 337, p=0.0005). Secondary outcomes; the HBI at baseline was elevated (>, 4) in, 11 patients. Post-treatment HBI was consistent with clinical remission in all cases (11/15 vs., 0/15, p <0.0001 OR clinical remission = 0.27,95%CI:0.12–0.62). Nine patients who had baseline CRP elevation had achieved normal CRP after treatment, and the median CRP was significantly decreased from, 7.3 mg/L (1.8 -18.0) to, 1.6 mg/L (IQR, 1.0 –, 3.2), p=0.025. However, there were no significant changes in FC pre-and post-treatment. In addition, baseline VCE demonstrated ulcerated SB strictures in, 3 patients, 2 had non-ulcerated strictures on the second VCE. No capsule retention or other adverse events were observed. Conclusion Adalimumab led to significant improvement of small intestinal endoscopic healing in Crohn’s disease, with, 53% achieving complete healing.
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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 | 0.005 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| 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".