P-066 YI Randomized Clinical Trial for Clinical Response Evaluation in Crohnʼs Disease
Bibliographic record
Abstract
The introduction of biological therapy was a milestone in the treatment of Crohn's Disease (CD). Biological therapy promotes mucosal healing and decrease rates of hospitalizations and surgeries. In the current literature there are no prospective clinical trials comparing the clinical efficacy of Infliximab (IFX) versus adalimumab (ADA) in CD. The purpose of this study was to compare the efficacy of IFX versus ADA on clinical response and improvement of quality of life in patients with CD. A prospective and longitudinal study was carried out in patients with CD treated with anti-TNF agents. Patients with biologic therapy indication were randomized to receive either IFX or ADA and were evaluated at weeks 0, 14, 30 and 54 of treatment. The Crohn's Disease Activity Index (CDAI) was used to assess the clinical response of CD patients. We considered patients to be in long-term clinical remission if the CDAI was less than 150 through week 54 from the start of anti-TNF treatment. The inflammatory bowel disease questionnaire (IBDQ) was used to measure the health-related quality of life (HRQoL). Clinical data were evaluated as age, gender, disease duration, smoking and laboratory tests such as hemoglobin, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and albumin. Statistical analysis: descriptive analysis, ANOVA with repeated measures considering the interaction drug × time, then the adjusted Tukey's multiple comparison test. Sixteen individuals were included in this study, 10 female, 11 Caucasians and 6 smokers, the mean age was 37 (±12.5) years and a mean of 4.9 (±5.7) years of disease duration. They had the following characteristics determined by the Montreal classification: A1 (6.25%), A2 (75%) and A3 (18.75%); L1 (25%), L2 (31.25%) and L3 (43.75%); B1 (18.75%), B2 (50%), B3 (25%) and B2/B3 (6.25%). Mean of CDAI of 187.7 (±117.1) points, hemoglobin average of 11.9 (SD: 2.6) g/dL, ESR of 35.1 (SD: 27.7) mm/h, CRP of 2.5 (SD: 2.0) mg/dL, and albumin of 3.4 (SD: 0.8) g/dL. Nine of them received Adalimumab and 7 received Infliximab. Thirteen (86, 67%) experienced clinical response during follow-up (8 received ADA (88.9%) and 5 received IFX (83.3%); P = 1.0. Two (12.5%) patients underwent hospitalization and surgery, one from each group (P = 1.0), with no death in both groups. Only 8 patients completed 30 weeks and 4 patients have completed 54 weeks of treatment. There was an improvement in quality of life during follow-up for both treatment groups (P = 1.0). In ADA group, 62.5% of patients presented good/excellent quality of life at week 0 and 100% at week 54. In IFX group the percentage of patients with good/excellent quality of life increased from 14.3% to 100%. There was clinical response and improvement of quality of life of patients with CD treated with Biological Therapy. There was no difference between IFX and ADA group.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.021 | 0.002 |
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".