title: Effect of adalimumab on clinical laboratory parameters in patients with Crohn's disease: results from the CHARM trial.
abstract: BACKGROUND
  Nutritional deficiencies and anemia are common in Crohn's disease (CD).
  
  
  METHODS
  We 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 Crohn's Disease Activity Index (CDAI) score and changes in laboratory values were estimated at Weeks 4, 26, and 56.
  
  
  RESULTS
  The intention-to-treat 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 C-reactive protein concentration (all P < 0.05). 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 C-reactive protein (all P < 0.001).
  
  
  CONCLUSIONS
  Adalimumab therapy for moderately to severely active CD was associated with significant improvements in nutritional, hematologic, and inflammatory markers.
authors: University of Chicago Medical Center, Chicago, Illinois 60637, USA. drubin@medicine.bsd.uchicago.edu
authors: David T
authors: DT
authors: Rubin
authors: Parvez
authors: P
authors: Mulani
authors: Jingdong
authors: J
authors: Chao
authors: Paul F
authors: PF
authors: Pollack
authors: Arielle G
authors: AG
authors: Bensimon
authors: Andrew P
authors: AP
authors: Yu
authors: Subrata
authors: S
authors: Ghosh
mesh_terms: D000068879:Adalimumab; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D002908:Chronic Disease; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006402:Hematologic Diseases / Q000517:prevention & control*; D006801:Humans; D007249:Inflammation / Q000517:prevention & control*; D008297:Male; D044342:Malnutrition / Q000517:prevention & control*; D008875:Middle Aged; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D000068879:Adalimumab