title: Adalimumab in Crohn's disease patients: pharmacokinetics in the first 6 months of treatment.
abstract: BACKGROUND
  Adalimumab is an effective therapy for Crohn's disease patients. However, there is limited knowledge on the pharmacokinetic properties of adalilumab in patients with Crohn's disease.
  
  
  OBJECTIVE
  To assess the pharmacokinetic properties of adalilumab in a retrospective clinical cohort of patients with Crohn's disease, naïve to anti-tumour necrosis factor alpha therapy (anti-TNF).
  
  
  METHODS
  In a single tertiary centre, a clinical retrospective cohort was formed out of 76 patients with Crohn's disease who started adalilumab treatment (160/80/40EOW) between July 2007 and September 2010. We serially evaluated adalilumab serum levels at week 0, 12 and 28.
  
  
  RESULTS
  Patients were followed for a median time of 201 days (range 120-244) and received a median of 14 adalilumab injections (range 6-25). Adalilumab levels, although divergent between patients, were stable between week 12 and week 28. There was no correlation between adalilumab level and time since last administration (r = -0.061). In a multivariable regression analysis of patient factors influencing week 28 adalilumab levels, the regression model containing CRP at week 28 and BMI at baseline weakly but significantly predicted week 28 adalilumab levels (R(2) = 0.193, P = 0.004). Concomitant use of immunosuppressives was not a significant predictor (P = 0.304).
  
  
  CONCLUSIONS
  Intra-individual adalilumab levels seem very stable during the first 28 weeks of treatment, whereas inter-individual levels vary. Adalilumab levels appear stable over a 2-week period, as the time since last adalilumab administration did not affect the adalilumab level. CRP and BMI weakly predict week 28 adalilumab levels, whereas the use of immunosuppressives does not.
authors.affiliation: Department of Gastroenterology and Hepatology, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, The Netherlands.
authors.forename: M R K L
authors.initials: MR
authors.lastname: Lie
authors.forename: M P
authors.initials: MP
authors.lastname: Peppelenbosch
authors.forename: R L
authors.initials: RL
authors.lastname: West
authors.forename: Z
authors.initials: Z
authors.lastname: Zelinkova
authors.forename: C J
authors.initials: CJ
authors.lastname: van der Woude
mesh_terms: D000068879:Adalimumab; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000493:pharmacokinetics* / Q000627:therapeutic use; D015992:Body Mass Index; D002097:C-Reactive Protein / Q000032:analysis; D003424:Crohn Disease / Q000097:blood* / Q000188:drug therapy; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D014409:Tumor Necrosis Factor-alpha; D002097:C-Reactive Protein; D000068879:Adalimumab