title: Infliximab for Crohn's disease in clinical practice: the experience of a single center in romania.
abstract: OBJECTIVE
  The aim of the study was to report the efficacy and tolerability of infliximab therapy in the first 24 patients with refractory and fistulizing Crohn's disease (CD) treated at our center between August 2000-May 2002.
  
  
  METHODS
  The medical records of 24 patients (13 males, 11 females) treated with infliximab for refractory or fistulizing CD were reviewed. CD was diagnosed using conventional clinical, endoscopical and histological criteria. Infliximab was administered at a dose of 5 mg/kg body mass as a 2-hours i.v. infusion in a single infusion for inflammatory CD, and a triple infusion regimen for fistulizing CD (at 0, 2, and 6 weeks). Efficacy was analysed by means of 1) clinical outcome, 2) mucosal healing, 3) steroid tapering/sparing effect and 4) need for surgery.
  
  
  RESULTS
  Sixteen patients were treated for inflammatory CD, 7 patients for fistulizing CD and 1 patient for both inflammatory and fistulizing CD. A total number of 49 infusions were administered during the study interval (median number 2); the median time of follow-up was 26 weeks (12-79 weeks). An overall positive clinical response was seen in 12/16 patients (75 % with inflammatory CD and 5/7 patients (71.4 %) with fistulizing CD. The median time to clinical response was 5.6 days (range 1-11 days) and the median duration of clinical response was 6.53 mo. (4 weeks-21 months). Mucosal healing was noted in 10/17 (58 %). Steroid tapering or cessation was succesfully attempted in 17 patients (80.9 %), complete steroid withdrawal being possible in 15 patients (71.4 %). Three non-responder patients required surgical therapy. Infusion-related adverse reactions were seen in 4 patients (16.6 %). Two patients (8.3 %) developed severe adverse events; one of them, a young female patient with intrapartum onset of a severe CD developed sepsis and deceased from intavascular disseminated coagulopathy. During the follow-up, none of our patients developed serious infections, tuberculosis or malignancy.
  
  
  CONCLUSIONS
  Our study provides additional evidence that infliximab is beneficial and safe in clinical practice for refractory and fistulizing CD patients. Additionally, our study proved the high mucosal healing rate and the steroid-sparing and surgery-saving properties of infliximab
authors.affiliation: Center of Gastroenterology and Hepatology, Fundeni Clinical Institute, Sos. Fundeni no. 258, 71637 Bucharest, Romania.
authors.forename: Liana
authors.initials: L
authors.lastname: Gheorghe
authors.forename: Cristian
authors.initials: C
authors.lastname: Gheorghe
authors.forename: Mihaela
authors.initials: M
authors.lastname: Badea
authors.forename: Roxana
authors.initials: R
authors.lastname: Vădan
authors.forename: Iuliana
authors.initials: I
authors.lastname: Pârvulescu
authors.forename: Cristina
authors.initials: C
authors.lastname: Toader
authors.forename: Letiţia
authors.initials: L
authors.lastname: Tugui
authors.forename: Octavian
authors.initials: O
authors.lastname: Papuc
authors.forename: Radu
authors.initials: R
authors.lastname: Ionescu
authors.forename: Carmen
authors.initials: C
authors.lastname: Preda
authors.forename: Ion
authors.initials: I
authors.lastname: Călin
authors.forename: Mircea
authors.initials: M
authors.lastname: Diculescu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab