Authors: Rubin David T Mulani Parvez Chao Jingdong Pollack Paul F Bensimon Arielle G Yu Andrew P Ghosh Subrata
Publish Date: 2012/05/01
Volume: 18, Issue: 5, Pages: 818-825
Abstract
David T Rubin Parvez Mulani Jingdong Chao Paul F Pollack Arielle G Bensimon Andrew P Yu Subrata Ghosh Effect of Adalimumab on Clinical Laboratory Parameters in Patients with Crohns Disease Results from the CHARM Trial Inflammatory Bowel Diseases Volume 18 Issue 5 1 May 2012 Pages 818–825 https//doiorg/101002/ibd21836We evaluated the effect of adalimumab on changes in laboratory values using data from CHARM in which patients were randomized to adalimumab 40 mg every other week eow adalimumab 40 mg weekly or placebo for 56 weeks Mean changes in laboratory values from baseline to Weeks 26 and 56 were compared between adalimumab and placebo using analysis of covariance models Percentages of patients with suboptimal laboratory values at Weeks 26 and 56 were compared between treatment groups using Cochran–Mantel–Haenszel CMH tests Pearson correlation coefficients for associations between changes in Crohns Disease Activity Index CDAI score and changes in laboratory values were estimated at Weeks 4 26 and 56The intentiontotreat analysis included 778 patients randomized to adalimumab eow N = 260 adalimumab weekly N = 257 or placebo N = 261 Baseline abnormalities in laboratory values were common across treatment groups CMH tests revealed significantly lesser rates of suboptimal laboratory values with adalimumab vs placebo at Week 26 including hypoalbuminemia calcium deficiency low hemoglobin low hematocrit low red blood cell count elevated platelet count and elevated Creactive protein concentration all P 005 These improvements persisted at Week 56 Improvements in CDAI from baseline to Weeks 4 26 and 56 were significantly correlated with changes from baseline for albumin hemoglobin and Creactive protein all P 0001
Keywords: