title: Early clinical remission and normalisation of CRP are the strongest predictors of efficacy, mucosal healing and dose escalation during the first year of adalimumab therapy in Crohn's disease.
abstract: BACKGROUND
  Adalimumab is a fully human monoclonal antibody targeting tumour necrosis factor with proven efficacy in the treatment of Crohn's disease (CD).
  
  
  OBJECTIVE
  To investigate the predictors of medium-term clinical efficacy and mucosal healing during adalimumab therapy, in patients with CD, in specialised centres approved for biological therapy in Hungary.
  
  
  METHODS
  Data capture of the 201 CD patients was standardised and prospective (male/female: 112/89, median age: 33.0 years, duration: 8 years). Previous infliximab therapy had been administered in 48% of patients, concomitant steroids in 41%, azathioprine in 69% and combined therapy in 27% of patients.
  
  
  RESULTS
  Overall clinical response and remission rates at 24 weeks were 78% and 52%, respectively; at 52 weeks were 69% and 44%, respectively. Endoscopic improvement and healing were achieved in 43% and 24% of patients. In a logistic regression model, clinical efficacy and CRP at week 12, need for combined immunosuppression at induction, shorter disease duration and smoking were identified as independent predictors for 12-month clinical outcome, whereas CRP at week 12, clinical remission at week 24, inflammatory parameters and nonsmoking were associated to endoscopic improvement/healing. Intensification to weekly dosing was needed in 16% of patients. Parallel azathioprine therapy and clinical remission at week 12 were inversely associated with dose escalation.
  
  
  CONCLUSIONS
  Clinical efficacy and normalised CRP at week 12 (early deep clinical remission) are associated with medium-term clinical efficacy and mucosal healing during adalimumab therapy, whereas need for combined immunosuppression at induction and smoking status are predictors for non-response. Parallel azathioprine therapy may decrease the probability for dose escalation.
authors: Semmelweis University, Budapest, Hungary.
authors: L S
authors: LS
authors: Kiss
authors: T
authors: T
authors: Szamosi
authors: T
authors: T
authors: Molnar
authors: P
authors: P
authors: Miheller
authors: L
authors: L
authors: Lakatos
authors: A
authors: A
authors: Vincze
authors: K
authors: K
authors: Palatka
authors: Z
authors: Z
authors: Barta
authors: B
authors: B
authors: Gasztonyi
authors: A
authors: A
authors: Salamon
authors: G
authors: G
authors: Horvath
authors: G T
authors: GT
authors: Tóth
authors: K
authors: K
authors: Farkas
authors: J
authors: J
authors: Banai
authors: Z
authors: Z
authors: Tulassay
authors: F
authors: F
authors: Nagy
authors: M
authors: M
authors: Szenes
authors: G
authors: G
authors: Veres
authors: B D
authors: BD
authors: Lovasz
authors: Z
authors: Z
authors: Vegh
authors: P A
authors: PA
authors: Golovics
authors: M
authors: M
authors: Szathmari
authors: M
authors: M
authors: Papp
authors: P L
authors: PL
authors: Lakatos
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D002097:C-Reactive Protein / Q000378:metabolism*; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects* / Q000276:immunology; D016015:Logistic Models; D008297:Male; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012074:Remission Induction; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D002097:C-Reactive Protein; D000068879:Adalimumab