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Record W2915016304 · doi:10.1093/ecco-jcc/jjy222.301

P177 Small intestinal mucosal healing assessed by video capsule endoscopy in Crohn’s disease patient treated with adalimumab: The SIMCHA study—interim results

2019· article· en· W2915016304 on OpenAlexaff
Christine Verdon, Uri Kopylov, C.-Y. Chao, Sophie Restellini-Kherad, Marc Girardin, Waqqas Afif, Péter L. Lakatos, Talat Bessissow, Alain Bitton, Ernest G. Seidman

Bibliographic record

VenueJournal of Crohn s and Colitis · 2019
Typearticle
Languageen
FieldBiochemistry, Genetics and Molecular Biology
TopicInflammatory Bowel Disease
Canadian institutionsMcGill University Health Centre
Fundersnot available
KeywordsMedicineAdalimumabCapsule endoscopyGastroenterologyInternal medicineCrohn's diseaseClinical endpointInterim analysisSurgeryCapsuleDiseaseClinical trial

Abstract

fetched live from OpenAlex

Video capsule endoscopy (VCE) has been established as the most sensitive modality in evaluating small bowel (SB) Crohn’s disease (CD). Endoscopic mucosal healing is recognised as a key treatment target in IBD. However, studies have generally employed ileocolonoscopy. The aim of this study was to investigate SB mucosal healing of CD after 6 months of adalimumab therapy using VCE. Prospective single-centre study in consecutive adult CD patients (>17 years) with moderate-to-severe SB involvement, defined by a baseline VCE examination at diagnosis with a Lewis score > 790 (normal <135, mild disease 135–790) in at least one tertile. Exclusion criteria included the use of drugs known to induce SB lesions such as NSAIDs for a minimum of 1 month. Patients were also excluded if there was a history suggestive of obstructive symptoms, known strictures or a failed patency capsule examination. Patients were all treated with adalimumab monotherapy for 24 weeks prior to undertaking a second VCE. Primary endpoint was the Lewis score on repeat VCE at 24 weeks. Mucosal healing was defined as a repeat Lewis score <350, whereas partial response was defined as a >50% decrease in repeat Lewis score. Secondary outcomes included clinical index of remission (Harvey–Bradshaw Index <5) and faecal calprotectin. Interim results are available for the first 14 consenting patients (8 males, 6 females) recruited (2012–2018). Mean baseline Lewis score was 1940 (range 475–6340). Mean Lewis score on second VCE was 331 (range 112–2734; p = 0.0005 vs. baseline). Complete mucosal healing was observed in 7 (50%) cases, and partial response in 5 others. The mean decrease in Lewis score was 1632 (range 363–5189), representing a mean reduction of 80.2%. Baseline VCE demonstrated one or more ulcerated SB strictures in three cases; two had non-ulcerated strictures at Week 24 that were traversed. No capsule retention or other adverse events were observed. The HBI was elevated (>4) in 10 cases prior to starting therapy. Repeat HBI was consistent with clinical remission (HBI < 4) in all cases at Week 24. Mean faecal calprotectin decreased from 409 (range 62–1676) to 135 (range 30–329), but the difference did not achieve significance (p = 0.1). Adalimumab led to significant improvement of small intestinal mucosal Crohn’s disease, with 50% achieving mucosal healing. Our preliminary data suggest that VCE is a safe and effective method to diagnose and monitor SB mucosal healing in CD.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.001
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.002
Threshold uncertainty score0.009

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0020.001
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0010.001
Open science0.0000.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0020.001

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.

Opus teacher head0.008
GPT teacher head0.241
Teacher spread0.232 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

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".

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Citations0
Published2019
Admission routes1
Has abstractyes

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