P0978 Effectiveness of risankizumab in moderate-to-severe Crohn’s Disease: A Canadian multicentric real-world study
Notice bibliographique
Résumé
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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,005 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,002 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,000 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».