P0978 Effectiveness of risankizumab in moderate-to-severe Crohn’s Disease: A Canadian multicentric real-world study
Bibliographic record
Abstract
Abstract Background Risankizumab is an interleukin-23 (IL-23) targeting monoclonal antibody, and has recently been approved for the treatment of moderate-to-severe Crohn’s Disease (CD). To this date, there is limited effectiveness and safety real-world data. Methods We performed a retrospective chart review at 5 inflammatory bowel disease centers in Canada between January 2023 and November 2023 to evaluate the safety and effectiveness of risankizumab in moderate-to-severe Crohn’s Disease. Adult patients with confirmed CD diagnosis on risankizumab for active clinical or endoscopic disease were included. Patients with indeterminate colitis, and patients treated for post-operative recurrence prophylaxis were excluded. Clinical, biochemical and endoscopic data was collected at 3, 6, and 12 months.We evaluated the rates of clinical remission (defined as Harvey-Bradshaw Index (HBI) <5) and response (decrease in HBI of >50%), biochemical remission (CRP<5mg/L and/or fecal calprotectin (FCAL) < 250ug/g), as well as endoscopic remission (SES-CD <4) and response (SES-CD decrease >50%) at each time point. If HBI or SES-CD scores were not available, treating physicians’ assessments of response and remission were used. Requirement for steroids, drug discontinuation, and drug-associated adverse events were also collected. Results A total of 335 patients were included in the study. Baseline data is presented in Table 1. Median age was 39, and 172 (51.3) of patients were female. Most patients (304, 90.7%) had previous biologic exposure, and 112 (33.4%) patients had been exposed to three or more biologics. Overall, 131/235 (55.7%) patients clinically responded at 3 months, and 121/233 (51.9%) were in clinical remission. At 12 months, rates of clinical response and remission were similar (73/129, 56.6% and 74/132, 56.1% respectively). Endoscopic remission was noted in 6/17 (35.3%), 13/41 (31.7%), and 29/72 (40.3%) at 3, 6 and 12 months respectively. Normalization of biochemical parameters at 12 months was found in 73/99 (73.7%) of patients for CRP, and 21/49 (42.9%) for FCAL. Patients were less likely to require steroids over time, with respectively 49 (14.6%), 25 (7.5%) and 15 (4.5%) of them with active steroid use at 3, 6 and 12 months. Forty-seven (16.1%) patients had discontinued risankizumab prior to 12 months of use. By 12 months, 28 (8.4%) had to undergo surgery for active disease, and 41 (12.2%) required hospitalization. Conclusion In this real-world, multicentric, Canadian study, risankizumab was an effective therapy in the management of Crohn’s Disease in a population with significant number of patients with refractory disease.
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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 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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".