title: [Predictors of efficacy, mucosal healing and dose intensification during the first year of adalimumab therapy in patients with luminal and fistulizing Crohn's disease. National data from Hungary].
abstract: Adalimumab is a fully human monoclonal antibody targeting tumor necrosis factor with proven efficacy in the treatment of Crohn's disease in clinical trials. The aim of the present study was to investigate the predictors of medium term clinical efficacy and mucosal healing during adalimumab therapy in patients with Crohn's disease in specialized centers approved for biological therapy in Hungary.
  
  
  METHODS
  Data of 201 Crohn's disease patients were prospectively captured (male/female: 112/89, median age: 24 years, duration: 8 years). Previous infliximab therapy was given in 97 (48.3%) patients, concomitant steroids in 41.3% and azathioprine in 69.2% (combined: 26.4%) of patients.
  
  
  RESULTS
  Overall clinical response and remission rates at 24 and 52 weeks were 78% and 52%, and 69.4% and 44.4%, respectively. Endoscopic improvement and healing was achieved in 43.1% and 23.6%, respectively. In a logistic regression model, clinical efficacy and normalized C-reactive protein at week 12, need for combined immunosuppression at induction, shorter disease duration and smoking were identified as independent predictors for 12-month clinical outcome, while normalized C-reactive protein at week 12, clinical remission at week 24, frequency of previous relapses and smoking were associated to endoscopic improvement/healing. Dose intensification to weekly dosing was needed in 16.4%. Parallel azathioprine therapy and clinical remission at week 12 was inversely associated to dose escalation to weekly dosing.
  
  
  CONCLUSIONS
  Clinical efficacy and normalized C-reactive protein at week 12, need for combined immunosuppression, luminal disease and smoking are predictors for medium term clinical efficacy/mucosal healing during adalimumab therapy, while parallel azathioprine therapy may decrease the probability for dose escalation.
authors.affiliation: Semmelweis Egyetem, Általános Orvostudományi Kar I. Belgyógyászati Klinika Budapest.
authors.forename: Lajos Sándor
authors.initials: LS
authors.lastname: Kiss
authors.forename: Tamás
authors.initials: T
authors.lastname: Szamosi
authors.forename: Tamás
authors.initials: T
authors.lastname: Molnár
authors.forename: Pál
authors.initials: P
authors.lastname: Miheller
authors.forename: László
authors.initials: L
authors.lastname: Lakatos
authors.forename: Aron
authors.initials: A
authors.lastname: Vincze
authors.forename: Károly
authors.initials: K
authors.lastname: Palatka
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Bartha
authors.forename: Beáta
authors.initials: B
authors.lastname: Gasztonyi
authors.forename: Agnes
authors.initials: A
authors.lastname: Salamon
authors.forename: Gábor
authors.initials: G
authors.lastname: Horváth
authors.forename: Gábor Tamás
authors.initials: GT
authors.lastname: Tóth
authors.forename: Klaudia
authors.initials: K
authors.lastname: Farkas
authors.forename: János
authors.initials: J
authors.lastname: Banai
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Tulassay
authors.forename: Ferenc
authors.initials: F
authors.lastname: Nagy
authors.forename: Mária
authors.initials: M
authors.lastname: Szenes
authors.forename: Gábor
authors.initials: G
authors.lastname: Veres
authors.forename: Barbara Dorottya
authors.initials: BD
authors.lastname: Lovász
authors.forename: Zsuzsanna
authors.initials: Z
authors.lastname: Végh
authors.forename: Petra Anna
authors.initials: PA
authors.lastname: Golovics
authors.forename: Miklós
authors.initials: M
authors.lastname: Szathmári
authors.forename: Mária
authors.initials: M
authors.lastname: Papp
authors.forename: Péter László
authors.initials: PL
authors.lastname: Lakatos
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000494:pharmacology*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000494:pharmacology*; D061067:Antibodies, Monoclonal, Humanized; D001379:Azathioprine / Q000008:administration & dosage / Q000494:pharmacology; D015415:Biomarkers / Q000097:blood; D002097:C-Reactive Protein / Q000378:metabolism; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006814:Hungary; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000494:pharmacology; D007412:Intestinal Fistula / Q000209:etiology*; D007413:Intestinal Mucosa / Q000187:drug effects*; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D016017:Odds Ratio; D011237:Predictive Value of Tests; D012008:Recurrence; D012907:Smoking / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D015415:Biomarkers; D007166:Immunosuppressive Agents; D002097:C-Reactive Protein; D000068879:Adalimumab; D001379:Azathioprine