Effectiveness and tolerability of repeated treatment with infliximab in patients with Crohn's disease: a retrospective data analysis in Germany.

AIM: The aim was to evaluate the efficacy and safety of repeated treatment with infliximab in patients with chronic active Crohn's disease under routine conditions in clinics and private practices.
METHODS: Patients with active Crohn's disease were treated with a total of 567 infusions (420 re-infusions) of infliximab. The treatment schedule was at the discretion of the treating physician. Efficacy and tolerability were documented by a standardized questionnaire.
RESULTS: There were indications for therapy in 46% of patients with chronic active disease, fistulas in 15% and combined symptoms in 38%. The mean disease duration was 9.4 years. At the beginning of therapy, 76% of patients were on corticosteroids, 67% received 5-aminosalicylates and 48% azathioprine. The average dose of infliximab administered was 300 mg; the mean interval between individual infusions was 8.7 weeks. Following treatment with infliximab, steroids could be withdrawn in 47% and reduced in 33% of patients, whereas the dosage of 5-aminosalicylates and azathioprine mostly remained unchanged. The efficacy and tolerability of infliximab were judged by the physicians as being very good or good in 73.4 and 88.4% of patients respectively. Further treatment with the anti-TNFalpha antibody was planned for 61% of patients. Improvement of Crohn's Disease Activity Index (CDAI), white blood cell (WBC) and C-reactive protein (CRP) levels was noted in almost all patients.
CONCLUSION: Infliximab used in an individually adapted regimen induced a significant clinical response in the majority of patients with refractory and fistulating Crohn's disease. In nearly 80% of patients corticosteroids could be withdrawn or reduced and the majority of patients were on azathioprine at the end of follow-up procedures.