A Treat to Target Approach Decreases the Rate of CD-Related Adverse Outcomes versus a Clinical Approach in Patients With Moderate to Severely Active Crohnʼs Disease: Data From CALM 2017 ACG Governors Award for Excellence in Clinical Research
Bibliographic record
Abstract
Introduction: Superior endoscopic outcomes in patients (pts) with moderate to severe Crohn's disease (CD) were achieved with tight control (T2T) of inflammation using biomarkers (C-reactive protein [CRP] and fecal calprotectin [FC]) compared to standard clinical management (CM) in CALM1. Differences in hospitalizations and serious disease-related complications between the study arms were analyzed. Methods: Immunosuppressive and biologic-naïve adults with CD; baseline CDAI>150-450 (+/- corticosteroids [CS]), active endoscopic CD (overall CDEIS>6 and sum of CDEIS subscores >6 in ≥1 segment with ulcers), and CRP≥5 mg/L and/or FC≥250 ìg/g received prednisone burst/taper ≤8 weeks (wk), then randomized to T2T or CM at wk 9. Early randomization was allowed for some pts. Pts received ≤4 treatment options in a stepwise manner based on pre-defined success criteria: no treatment; 160/80 mg adalimumab (ADA) wks 0/2, 40 mg every other wk; ADA 40 mg wkly; ADA 40 mg wkly+azathioprine 2.5 mg/kg/day. CD-related hospitalizations, CD-related surgical procedures (major and non-major) and a composite endpoint of CD-related hospitalization or serious complication from randomization up to wk 48, were summarized as incidences or rates (events [E]/100 Patient Years [PY]). Chi-square test was used for differences between study arms. Hazard ratio (HR) of the composite endpoint was determined using Cox proportional hazard model. Any hospitalization was reported for all pts on or after randomization and up to 70 days after last dose. Results: A total of 244 pts were randomized 1:1 to T2T and CM. BL mean ± SD age was 31.6 ± 11.7 years and 57.8% were female. The rate of CD-related hospitalizations after randomization was significantly lower with T2T compared to CM (Table). The rate of CD-related surgical procedures and the proportion of pts with CD-related hospitalization or serious complication were numerically lower in T2T compared to CM (Table). The risk of CD-related hospitalization or serious complication was numerically lower with T2T than CM: HR=0.7, 95% CI 0.4-1.3, P=0.249.Table: No Caption availableConclusion: A T2T approach using tight control of inflammation by biomarkers leads to a reduction of major adverse outcomes indicative for a detrimental course of disease, including CD-related hospitalizations. A longer study is needed to confirm these findings.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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 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".