Infliximab for Crohn's disease in clinical practice: the experience of a single center in romania.
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
Gheorghe
Liana
L
Center of Gastroenterology and Hepatology, Fundeni Clinical Institute, Sos. Fundeni no. 258, 71637 Bucharest, Romania.
Gheorghe
Cristian
C
Badea
Mihaela
M
Vădan
Roxana
R
Pârvulescu
Iuliana
I
Toader
Cristina
C
Tugui
Letiţia
L
Papuc
Octavian
O
Ionescu
Radu
R
Preda
Carmen
C
Călin
Ion
I
Diculescu
Mircea
M
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
D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab