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Development and Validation of a Scoring System to Predict Outcomes of Vedolizumab Treatment in Patients with Crohn's Disease.

Gastroenterology; 2018 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-29857091
BACKGROUND & AIMS: As more treatment options for inflammatory bowel diseases become available, it is important to identify patients most likely to respond to different therapies. We created and validated a scoring system to identify patients with Crohn's disease (CD) who respond to vedolizumab.

METHODS:

We collected data from GEMINI 2 phase 3 trial of patients with active CD treated with vedolizumab for 26 weeks (n=814) and performed logistic regression analysis to identify factors associated with clinical, steroid-free, and durable remission (derivation set). We used these data to develop a clinical decision support tool, which we validated using data from 366 participants in a separate clinical practice observational cohort of patients with active CD treated with vedolizumab for 26 weeks (the RESULTS: In the derivation analysis, we identified absence of previous treatment with a tumor necrosis factor antagonist (+3 points), absence of prior bowel surgery (+2 points), absence of prior fistulizing disease (+2 points), baseline level of albumin (+0.4 points per g/L), and baseline concentration of C-reactive protein (reduction of 0.5 points for values between 3.0-10.0 mg/L and 3.0 points for values > 10.0 mg/L) as factors associated with remission. In the validation set, our model identified p CONCLUSIONS: We developed and validated a scoring system to identify patients with CD most likely to respond to 26 weeks of vedolizumab therapy. Further studies are needed to optimize its accuracy in select populations and determine its cost effectiveness.