Real-Life Data on the Use of Ustekinumab for the Treatment of Fistulas in Patients With Crohnʼs Disease
Notice bibliographique
Résumé
Introduction: Fistulas are a common manifestation of Crohn's disease (CD). Ustekinumab an interleukin 12/23 inhibitor was recently approved for the treatment of patients with moderate to severe CD. Data on its efficacy in fistulizing CD is limited. This study aims to assess its efficacy in CD patients with perianal and rectovaginal fistulas after its FDA approval in September 2016. Methods: We conducted a retrospective chart review of patients with fistulizing CD treated at a large metropolitan IBD center with ustekinumab between September 2016 and June 2017. Data was collected by EMR search. All patients had initial IV followed by subcutaneous ustekinumab dosing. Data collected included demographics, disease characteristics and location, previously failed immunosuppressive meds, concomitant immunosuppressive meds, and lab parameters including CRP, and CBC prior and after initiation of treatment. Pretreatment lab and clinical data was collected at the last visit up to 3 months preceding induction. Post treatment lab and clinical data was collected 1 to 6 months after the infusion aiming closest to the 3 month post-infusion time-point. Fistula response was defined as decrease in fistulous drainage or partial healing of fistulas. Fistula healing was defined as complete closure of fistulas. Clinical response and remission of CD were based on clinical evaluation. Results: We identified 9 CD patients with perianal and/or rectovaginal fistulas who were treated with ustekinumab. All patients had failed prior treatment with anti-TNFs; 5 out of 9 patients had failed treatment with vedolizumab; 5 patients had failed prior treatment with thiopurines; and 2 had failed treatment with methotrexate. During treatment, 3 patients were on concomitant treatment with 6-mercaptopurine and 2 patients with methotrexate. Fistula healing was seen in 1 out of 9 patients (11%), fistula response in 4 out of 9 patients (44%), and no response was seen in 2 out of 9 patients (22%). Fistula evaluation of 2 patients post initiation was pending. Clinical response was seen in 6 out of 9 patients (67%) and none of the patients showed clinical remission. Clinical evaluation was pending in 1 patient.Figure: Patient demographics, disease characteristics and previously failed immunosuppressive treatments. Age in years. Gender: F=Female, M=Male. Disease location as per Montreal Classification (L2: colon, L3: ileocolon, p: perianal). U=unknown.Figure: Concomitant immunosuppressive agents, fistula response or healing and clinical response or remission. CRP and WBCs as evaluated within 3 months prior to infusion and 1-6 months after infusion (for multiple existent lab values we included the ones closest to the infusion for pretreatment and to the 3-month time-point after infusion for the posttreatment). PreRx= Pretreatment and PostRx= Posttreatment. U= unknown.Conclusion: Ustekinumab appears to be effective in patients with fistulizing CD who have failed prior treatment with biologics. Larger studies are needed to examine its use in this patient population with an aggressive disease phenotype.
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 | 0,015 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,001 | 0,002 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| 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 ».