A145 “REAL WORLD” SAFETY AND EFFECTIVENESS OF VEDOLIZUMAB FOR ULCERATIVE COLITIS: RETROSPECTIVE STUDY FROM A TERTIARY CARE CANADIAN CENTRE
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Notice bibliographique
Résumé
Vedolizumab (VDZ), a humanized monoclonal antibody which targets the α4β7 integrin and prevents homing of lymphocytes to the gut, was approved by Health Canada in 2015 for treatment of moderate to severe ulcerative colitis (UC). Its gut selective mode of action offers potential for a lower risk of systemic infection while achieving similar or greater efficacy compared to conventional treatments. To assess clinical response and safety of VDZ. Retrospective cohort study from a tertiary care Canadian centre between May 2015 to August 2016. Adult patients with UC treated with VDZ, with follow-up after initiation of therapy, were eligible. Patients were identified through infusion center listings and data abstracted from electronic medical records, review of clinic records, endoscopy reports and infusion centre reports. Clinical response - defined as normalization of stool frequency and absence of rectal bleeding, as well as physician global assessment, and serious adverse events were assessed. Patients were eligible for safety analysis as long as at least one dose was received. Eighty-eight patients were included, with a median age of 47 years (range 18–85), 58% (51/88) male, 53% (47/88) tumor necrosis factor (TNF)-antagonist exposed with a median follow up of 17 weeks (range 0–61 weeks). The median disease duration was 7 years (range 0–46), 61% (54/88) had a history of disease extension beyond the splenic flexure and 23% (20/88) had a history or prior/active smoking. Patients received a median of 5 VDZ doses (range 1–13) and 47% (41/88) were receiving concomitant treatment with prednisone at the initiation of VDZ. 51% (29/57) of patients achieved clinical response by the end of their induction period (week 6) and 56% (20/36) achieved clinical response at 6 months and 64% (44/69) of patients overall achieved clinical response at some point during the study period. 24 patients underwent endoscopic evaluation after starting VDZ of which 7/24 patients (29%) were reported to have mucosal healing or improved mucosa. No infusion reactions were reported. In 7% (6/88) of patients there were reports of an infection which required antibiotics, of which four had an upper respiratory tract infection and only one patient was admitted for treatment of pneumonia. One patient discontinued VDZ secondary to arthralgia and lethargy after their initial dose. VDZ is a safe and effective treatment for UC in routine clinical practice. In this study, clinical response after induction was achieved in over half of patients by week 6 and close to 2/3 overall achieved clinical remission. Only one patient discontinued treatment due to reports of arthralgia and lethargy after the infusion. None
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 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 découle