Infliximab treatment of patients with severe, refractory Crohn's disease

Patients: 17 patients (7 M, 10 F, mean age: 32.1yrs) with fistulizing Crohn's disease have been treated with infliximab (INX) since Jan. 2002. The mean disease duration was 9.8 (min: 0.5, max: 26)yrs. Among patients a total number of 43 fistulas were present, 16 in enterocutaneous, and 27 in perianal localization.

Therapy: Five mg/kg of INX was administrated on days 0, 14, and 42. The CDAI decrease below 150 scores was considered for remission, however decreasing of CDAI by more than 70 points or a 50% reduction in the number of active fistulas reflected responsiveness.

Results: The mean CDAI was 132.2 vs. 202.5, and 18 vs. 43 actives fistulas were detected at the 1st day and 8th week, respectively. Upon CDAI decrease 7 patients, and on number of active fistulas 12 of them responded to the therapy. In case of 9 patients the therapy was performed more than ½ year earlier. Two of them were in remission on the 8th week and 4 patients after 6 months, respectively, furthermore 3 other subjects also responded to treatment. Among 5 patients the total number of active non-perianal fistulas decreased from 15 to 4 on the 8th week. Three of the patients have got the therapy 6 months earlier, and relapsing disease occurred in 1 case, no fistula was present in another patient, and the third one displayed 1 active fistula.

Complications: Anaphylactoid reaction was experienced in 1 patient, fever in 5, severe diarrhea in 3, and cholecystitis in 2 other patients.

Conclusions: INX therapy is an effective selective immunosuppressive treatment of severe CD, but one can not forget about its possible side effects. In case of patients with perianal fistula formation the CDAI score as criteria for indication is rather questionable, indeed more objective methods are necessary to evaluate fistula healing.