Predicting corticosteroid‐free endoscopic remission with vedolizumab in ulcerative colitis

• DOI: 10.1111/apt.14510
• Publication Date: 2018-01-23T03:52:28Z
• Authors: A. K. Waljee; B. Liu; K. Sauder; J. Zhu; S. M. Govani; R. W. Stidham; P. D. R. Higgins
• Keywords: Adult; Male; Remission Induction; Middle Aged; Antibodies, Monoclonal, Humanized; Prognosis; Endoscopy, Gastrointestinal; 3. Good health; Cohort Studies; Otolaryngology; Young Adult; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Clinical Trials, Phase III as Topic; Pharmacy and Pharmacology; Adrenal Cortex Hormones; Predictive Value of Tests; Health Sciences; Humans; Colitis, Ulcerative; Female; Algorithms; Retrospective Studies

SummaryBackgroundVedolizumab is an effective therapy for ulcerative colitis (UC), but costly and slow to work. New clinical responses occur after 30 weeks of therapy.AimsTo enable physicians, patients, and insurers to predict whether a patient with UC will respond to vedolizumab at an early time point after starting therapy.MethodsThe clinical study data request website provided the phase 3 clinical trial data for vedolizumab. Random forest models were trained on 70% and tested on 30% of the data to predict corticosteroid‐free endoscopic remission at week 52. Models were constructed using baseline data, or data through week 6 of vedolizumab therapy from 491 subjects.ResultsThe AuROC for prediction of corticosteroid‐free endoscopic remission at week 52 using baseline data was only 0.62 (95% CI: 0.53‐0.72), but was 0.73 (95% CI: 0.65‐0.82) when using data through week 6. A total of 47% of subjects were predicted to be remitters, and 59% of these subjects achieved corticosteroid‐free endoscopic remission, in contrast to 21% of the predicted non‐remitters. A week 6 prediction using FCP ≤234 μg/g was nearly as accurate.ConclusionsA machine learning algorithm using laboratory data through week 6 of vedolizumab therapy was able to accurately identify which UC patients would achieve corticosteroid‐free endoscopic remission on vedolizumab at week 52. Application of this algorithm could have significant implications for clinical decisions on whom to continue on this costly medication when the benefits of the vedolizumab are not clinically apparent in the first 6 weeks of therapy.