P1158 Patients with refractory and difficult-to-treat Inflammatory Bowel Disease are underrepresented in randomized clinical trials
Bibliographic record
Abstract
Abstract Background A significant proportion of patients with inflammatory bowel disease (IBD) do not respond to treatment. Recently, criteria to define difficult-to-treat (DTT) IBD have been proposed1. These include IBD refractory to at least 2 advanced therapies with different mechanisms of action. We aim to review the representation of patients with prior exposure to biologics, DTT-IBD, and other challenging phenotypes in randomized clinical trials (RCTs). Methods A scoping review was performed by reviewing all RCTs of advanced therapies in IBD. We updated the literature searches of two published systematic reviews of ulcerative colitis (UC)2 and Crohn’s disease (CD)3 searching MEDLINE, EMBASE, and the Cochrane Library up to December 2023. Results We included 140 RCTs, 73 in ulcerative colitis (UC), and 67 in Crohn’s disease (CD), comprising 44.799 patients. In UC, 53% (39/73) of studies included patients with prior exposure to other biologics, but only 19% (14/73) included patients exposed to two or more biologics. Moreover, only 5% (4/73) of studies included participants exposed to biologics with multiple mechanisms of action, or DTT, and these accounted for 2% of the total participants of UC RCTs. None of the trials reported efficacy results specific for DTT. In CD, 60% (47/67) of studies included patients with any prior biologic exposure, and 31% (21/67) allowed the participation of patients who received two or more biologics. Only one study (1.5%) reported efficacy results for patients exposed to multiple mechanisms of action, DTT-IBD, which accounted for 7.4% of the study participants and 0.1% of all those in CD trials. In CD, history of prior intestinal surgery was reported only in 28 of 67 studies (42%) for 2977 patients, or 14.5% of the total participants. Similarly, upper gastrointestinal involvement of CD was included only in 21 trials (31%) and present in 808 participants (3.9%). Instead, the majority of trials either excluded patients with locations proximal to the terminal ileum (35 RCTs; 52%) or did not report whether some participants had upper gastrointestinal locations (11 RCTs; 16%) In both UC and CD there was a trend towards greater inclusion of exposed and refractory patients in recent years. Conclusion Patients exposed to multiple advanced therapies and those with phenotypes of CD more challenging to manage remain underrepresented in clinical trials of IBD. References 1.Parigi TL, et al. Lancet Gastroenterol Hepatology 2023 2.Sedano R, et al. Journal Crohn & Colitis 2021 3.Almradi A, et al. Journal Crohn & Colitis 2021
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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 | 0.153 | 0.383 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.010 | 0.006 |
| Bibliometrics | 0.006 | 0.011 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.006 | 0.006 |
| Open science | 0.003 | 0.003 |
| Research integrity | 0.006 | 0.003 |
| Insufficient payload (model declined to judge) | 0.012 | 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".