Background: Vedolizumab, an anti-αβ integrin approved for intravenous (IV) treatment of moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD), was evaluated as a subcutaneous (SC) formulation in maintenance therapy for UC and CD in phase 3 VISIBLE 1, 2, and open-label extension studies, and recently approved in Europe, Australia, and Canada. Our aim was to evaluate efficacy and safety of IV and SC vedolizumab in clinically relevant UC and CD scenarios.
Methods: Post hoc data analyses from VISIBLE trials examined: (1) whether baseline characteristics predict clinical response to 2 vs 3 IV vedolizumab induction doses; (2) efficacy and safety of switching during maintenance vedolizumab IV to SC in patients with UC; (3) vedolizumab SC after treatment interruption of 1-46 weeks; (4) increasing dose frequency of vedolizumab SC from every 2 weeks (Q2W) to every week (QW) after disease worsening.
Clin Gastroenterol Hepatol
February 2023
Background & Aims: We evaluated the value of post-induction fecal calprotectin (FCP) concentration as a biomarker in patients with ulcerative colitis (UC) treated with a biologic.
Methods: This post hoc analysis of the GEMINI 1/GEMINI LTS (N = 620) and VARSITY (N = 771) trials evaluated the cross-sectional accuracy of post-induction FCP in identifying endoscopic activity and histologic inflammation, and the prognostic performance of FCP in identifying patients most likely to achieve endoscopic and histologic remission or require colectomy and UC-related hospitalization.
Results: The cross-sectional accuracy of FCP in identifying endoscopic activity and histologic inflammation was modest (63%-79%).
Purpose: To develop a patient-reported outcome measure for capturing visual and ocular symptoms before and after implantation of intraocular lenses (IOLs) for treatment of cataracts.
Design: Questionnaire development and validation study.
Methods: The Questionnaire for Visual Disturbances (QUVID) was developed based on a literature and instrument review; 13 clinician interviews among ophthalmologists in the United States and Europe; and 67 hybrid qualitative patient interviews among adult patients in the United States and Australia before and/or after monofocal, traditional multifocal, or trifocal IOL implantation.
Background: Patients with Crohn's disease (CD) are at risk of complications. Performance characteristics of a decision support tool assessing the risk of CD complications were evaluated.
Methods: CDPATH (formerly called the Personalized Risk and Outcome Prediction Tool [PROSPECT]) was calibrated and validated in 2 cohorts.