PTH-058 Golimumab: early experience and medium-term outcomes from two uk tertiary ibd centres
Notice bibliographique
Résumé
Introduction Golimumab was granted NICE approval for use in moderate-to-severe ulcerative colitis (UC) in February 2015, based on efficacy demonstrated in the PURSUIT trial program. However, there is relatively little observational effectiveness data regarding its use in clinical practice. We aimed to generate this type of ‘real world’ data by combining our cohorts at Guy’s and St Thomas’ and King’s College Hospitals. Method Records of patients commencing golimumab between September 2014 and December 2016 were screened. Those completing at least the 6 week induction phase were included. Clinical activity was evaluated using the Simple Clinical Colitis Activity Index (SCCAI) prior to treatment initiation and at the first clinical review following completion of induction therapy. Response was defined as an SCCAI reduction by 3 points or more. Remission was defined as an SCCAI of less than 3. Continuous data are summarised as medians (range). Pre- and post-induction values were compared using Wilcoxon signed-rank test. Results 50 UC patients completed golimumab induction therapy (age: 35 (20-72), disease duration 8 years (1-52), prior anti-TNF exposure: 14 (28%), concomitant immunomodulator: 37 (74%), follow-up: 7 months (2-25)). Paired pre- and post-induction SCCAI values were available for 26 patients and fell significantly from 7 (2-19) to 3 (0–8), respectively (p<0.001). Including 8 patients who did not have paired SCCAI data but stopped treatment due to non-response, 18/34 (53%) responded and 10/34 (29%) achieved remission, all of whom were steroid free. The overall rate of corticosteroid usage at golimumab initiation was 24/50 (48%) and withdrawal was successful in 15/24 (63%). Faecal calprotectin fell significantly (pre-induction:1096 (15–4800), post-induction:114 (11–4800), p=0.011 for n=20). CRP fell significantly (pre-induction:4 (1–46), post-induction:2 (1–34), p=0.038 for n=37). Post-induction endoscopy was carried out in 20 patients. Mayo scores were 0: 1 (5%), 1: 5 (25%), 2: 6 (30%), 3: 8 (40%). Abstract PTH-058 Figure 1 Conclusion Our experience mirrors previously reported, smaller real-world cohorts1,2 and demonstrates similar outcomes to those observed in the PURSUIT trials. These data demonstrate a meaningful reduction in clinical and biochemical disease activity as well as a steroid-sparing effect in patients with previously refractory disease. References . Bosca-Watts MM, et al. Short-term effectiveness of golimumab for ulcerative colitis: Observational multicenter study. World Journal of Gastroenterology. 2016;22(47):10432–10439. . Detrez I, et al. Variability in Golimumab Exposure: A ‘Real-Life’ Observational Study in Active Ulcerative Colitis. J Crohns Colitis2016; 10 (5): 575–581. Disclosure of Interest M. Samaan Conflict with: Takeda, Janssen, MSD, Hospira, P Pavlidis: None Declared, A Akintimehi: None Declared, L Medcalf: None Declared, G Chung-Faye: None Declared, P Dubois: None Declared, I Koumoutsos: None Declared, S Anderson: None Declared, J Sanderson: None Declared, BH Hayee: None Declared, P Irving Conflict with: MSD and Takeda, Conflict with: Abbvie, Warner Chilcott, Takeda, MSD, Vifor Pharma, Pharmacosmos, Topivert, Genentech, Hospira and Samsung Bioepis, Conflict with: Abbvie, Warner Chilcott, Ferring, Falk Pharma, Takeda, MSD, Johnson and Johnson, Shire
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 | 0,012 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,001 | 0,003 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,003 | 0,002 |
| Science ouverte | 0,001 | 0,004 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,010 | 0,002 |
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 ».