P0041 Assessment of real-world effectiveness of risankizumab in patients with moderate-severe Crohn’s disease in a global setting
Bibliographic record
Abstract
Abstract Background The primary treatment goals in Crohn’s disease (CD) are to control symptoms, such as abdominal pain and diarrhea, and induce long-term endoscopic remission. The biologic risankizumab (RZB) was approved in 2022 for the treatment of adult patients with moderate-severe CD. As data on RZB utilization and effectiveness are limited, this study aimed to assess the impact of RZB on disease remission and symptom control for optimizing treatment outcomes in patients with CD. Methods Data were drawn from the Adelphi Real World CD Disease Specific Programme, a cross-sectional survey with retrospective data collection of gastroenterologists (GIs) in France, Germany, Italy, Spain, the UK, and the USA from Feb 2023–Oct 2024. GIs provided data on their consulting patients with subjectively classified at RZB initiation moderate-severe CD reported demographics, clinical characteristics and symptoms at RZB initiation and at most recent consultation. Analyses were descriptive, Wilcoxon signed rank and McNemar tests were used to compare severity and symptoms at RZB initiation and at most recent consultation, respectively. Results Overall, 206 GIs reported data on 333 patients with moderate-severe CD receiving RZB. Mean (standard deviation; SD) patient age was 40.8 (13.0), disease duration was 4.7 (5.8) years; 54% were advanced therapy (AT, comprising biologics and small molecule therapies) naïve and 46% AT experienced (Table 1). Among all patients, 85% received RZB as a monotherapy; 6% received RZB with corticosteroids and 9% with 5-aminosalicylates and/or immunomodulators for; mean (SD) time on RZB among those with a known treatment duration (n=299) was 7.5 (7.5) months. Among patients receiving RZB for >6 months (n=140), 55% were in GI-reported clinical remission at most recent consultation. Among all patients, GI-reported moderate-severe disease severity significantly reduced from RZB initiation (100% of patients) to most recent consultation (55%; p<0.0001; Fig 1A). Key symptoms experienced at RZB initiation (abdominal pain, 87%; bloody diarrhoea, 29%; non-bloody diarrhoea, 59%; fatigue, 54%; bowel urgency, 41%) significantly reduced at most recent consultation with continued RZB treatment (48%, 9%, 35%, 38%, 20%, respectively; p<0.0001; Fig 1B). Conclusion In a real-world global setting, patients with moderate-severe CD treated with RZB experienced a significant reduction in GI-reported disease severity and improvement in key symptoms, and over half of patients were in GI-reported clinical remission. The improvement in symptoms and severity were greater among patients who were treated for a longer duration with RZB. These results highlight the real-world effectiveness of RZB in managing disease activity and symptom burden among patients over time.
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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 | 0.003 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 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".