P074 Comparative Risk of Clostridioides Difficile Infection in Vedolizumab vs anti-TNFa Agents in Biologic-Naïve Patients With Ulcerative Colitis
Notice bibliographique
Résumé
BACKGROUND: Clostridioides difficile infection (CDI) is associated with adverse outcomes in ulcerative colitis (UC). There is concern that vedolizumab, which inhibits lymphocyte trafficking to the intestines, may increase the risk of gastrointestinal infections such as CDI when compared to other biologics. We conducted a retrospective cohort study to determine if vedolizumab is associated with an increased risk of CDI compared to anti-TNFa agents in UC. METHODS: Retrospective cohort study of adult patients with UC initiating infliximab, adalimumab, or vedolizumab 6/1/14-12/31/20 at a large academic health system. Electronic records were manually reviewed. Patients with Crohn's disease, indeterminate colitis, prior biologic exposures, prior colectomy, and non-UC indications for biologics were excluded. Patients were followed until CDI, colectomy, biologic discontinuation/switch, or last gastroenterology encounter through 8/1/21. The primary outcome was time from biologic initiation to first CDI, defined as positive stool C. difficile toxin or toxigenic C. difficile polymerase chain reaction (PCR) with associated CDI antibiotic prescriptions. Secondary outcomes included CDI-related hospitalization, colectomy, or death within 30 days of CDI. The primary exposure was vedolizumab vs anti-TNFa therapy. Other independent variables included demographics and UC history/severity factors. Propensity scores (PSs) were calculated using logistic regression of vedolizumab vs anti-TNFa on the following covariates: age, sex, Caucasian, body mass index (BMI), disease duration, current systemic corticosteroid use, UC-related hospitalization within prior 12 months, last Mayo endoscopic subscore, Montreal disease extent, albumin, and malignancy history. Inverse probability of treatment weighting (IPTW) was performed using PSs. An univariable Cox proportional hazards model was fit to calculate the unadjusted hazard ratio (HR) of CDI for vedolizumab vs anti-TNFa. A multivariable, IPT-weighted Cox model was then fit with two additional covariates extrinsic to the PS: pre-biologic CDI and immunomodulator exposure (time-varying covariate). Patients were censored at loss of follow-up, biologic discontinuation, or colectomy. RESULTS: 805 UC patients initiated vedolizumab (n = 195) or anti-TNFa agents (n = 610). Vedolizumab patients were older and less commonly received systemic corticosteroids or had UC-related hospitalization within 12 months pre-biologic initiation. There were 43 CDIs over 1,436 patient-years follow-up. CDI and CDI hospitalization occurred less commonly with vedolizumab vs anti-TNFa (CDI: 1.0% vs 6.7%, p = 0.001; CDI hospitalization: 1.0% vs 3.8%, p = 0.042 by log-rank test). There were no differences in colectomies or deaths or exposure to antibiotics/corticosteroids during follow-up or within 30 days preceding CDI. The unadjusted Cox model demonstrated a lower hazard of CDI for vedolizumab vs anti-TNFa (HR 0.17, 95% CI 0.04-0.71). The multivariable IPT-weighted Cox model demonstrated no difference in hazard of CDI for vedolizumab vs anti-TNFa (HR 0.33, 95% CI 0.05-2.03) or immunomodulator exposure (HR 1.01, 95% CI 0.41-2.40). Pre-biologic CDI was associated with an increased hazard of CDI (HR 5.95, 95% CI 2.93-12.09). Among patients who developed CDI, 17/43 (39.5%) had pre-biologic CDI a median of 227 days (IQR 160-550 days) preceding CDI. CONCLUSION: Our study did not identify an increased risk of CDI associated with vedolizumab vs anti-TNFa agents after controlling for UC severity. We hope that these findings will reassure UC providers considering vedolizumab as a first-line biologic agent in the context of gastrointestinal infectious risks.
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 | 0,001 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 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 ».