, Volume 20, Issue 1, pp 18-23
Date: 30 Sep 2004

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

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Abstract

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 Following treatment with infliximab, steroids could be withdrawn in 47% and reduced in 33% of patients, whereas the dosage of 5-aminosalicylates and azathioprine mostly remained unchanged.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-TNFα 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 In nearly 80% of patients corticosteroids could be withdrawn or reduced and the majority of patients were on azathioprine at the end of follow-up procedures.