Clinical outcome of Crohn's disease treated with infliximab.
OBJECTIVE
Controlled studies in humans have shown the role of antibodies to tumor necrosis factor-alpha in the treatment of both fistulizing and inflammatory Crohn's disease. The aim of this study is to report the results of a multicenter clinical trial to evaluate efficacy of infliximab in Crohn's disease patients who are refractory to conservative drugs or fistulizing Crohn's disease.


METHODS
This trial was carried out at 5 university and community hospitals, in Turkey. A total of 25 patients with Crohn's disease that were unresponsive to conventional medical therapy, participated; 17 of the 25 were in the fistulizing disease group and 8 were in the inflammatory disease group. Clinical response was classified according to fistula drainage, diarrhea as positive response or no response.


RESULTS
Overall response rate was 92% (23/25), regardless of the disease group, after first infusion of infliximab. Sixteen out of 17 patients in the fistulizing disease group had a positive response. Fourteen of the 16 positive responders later relapsed. Median duration of response was 8 weeks (range, 2-35 wk). Active inflammatory disease patients had a positive response rate of 75% (6/8) and two of the patients were nonresponders. A further two patients relapsed at week 14. Two patients in both arms of the study were still in remission at the end of the study. Major adverse events were: pneumonia in one patient, skin infections in two patients, pulmonary thromboembolism and death in one patient.


CONCLUSIONS
Infliximab treatment seems to be more effective in Crohn's disease patients especially in those with fistulizing disease than those with non-fistulizing, inflammatory disease. It is evident that maintenance of remission might be achieved with ongoing maintenance therapy. We suggest maintenance of infliximab therapy.
Arslan
Serap
S
Dept. of Gastroenterology, Hacettepe University Medical School, 06100, Sihhiye, Ankara, Turkey. searslan@hacettepe.edu.tr
Kav
Taylan
T
Besisik
Fatih
F
Kaymakoglu
Sabahattin
S
Pinarbasi
Binnur
B
Tözün
Nurdan
N
Hamzaoglu
Hülya Over
HO
Duman
Deniz
D
Ulker
Aysel
A
Parlak
Erkan
E
Palabiyikoglu
Murat
M
Dökmeci
Abdülkadir
A
D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000069285:Infliximab; D007412:Intestinal Fistula / Q000209:etiology; D008297:Male; D008875:Middle Aged
D000911:Antibodies, Monoclonal; D000069285:Infliximab