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* = Presenting author

P586 Cyclophosphamide pulse therapy in severe refractory Crohn’s disease

F. Baer*1, T. Krause2, A. Stallmach3, N. Teich4, C. Maaser5, J. Maul6, U. Helwig7, K. Fellermann1, J. Buening1

1University hospital of Luebeck, Department of Internal Medicine I, Luebeck, Germany, 2Gastroenterologie Opernstraße, Kassel, Germany, 3University Hospital of Jena, Department of Gastroenterology, Jena, Germany, 4Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten, Leipzig, Germany, 5Hospital Lüneburg, Department of Internal Medicine, Lüneburg, Germany, 6Campus Benjamin Franklin, Charité – Universitätsmedizin Berlin, Department of Medicine I, Berlin, Germany, 7Internistische Praxengemeinschaft Oldenburg, Oldenburg, Germany

Background

Although new strategies have been introduced in the therapy of Crohn’s disease (CD), patients remain refractory to current regimens including tumour necrosis factor (TNF) antibodies. Previous data from single-centre studies indicated cyclophosphamide pulse therapy (CPT) as being effective for induction of remission in steroid-refractory cases. The aim of the present study was to evaluate the efficacy and safety of CPT in refractory CD.

Methods

Patients with refractory CD undergoing CPT were retrospectively identified in 18 IBD centres of the German IBD Study Group (GISG) and registered. The CPT was individually decided by the treating physician without any study regulations. Data were recorded until the end of cyclophosphamide treatment (mean duration 120 days, [12–130 d]). In total, 40 patients (12 male, median age 36 years, [18–72 yr]) were included for analysis. Of these, 82% had previously been treated with thiopurines, and 90% had previously receive at least 1 TNF-antibody. Ongoing steroid treatment was observed in 87% of the cohort. Intestinal surgery was found in 56% of the patients, and 32% suffered from recurring fistulas.

Results

Patients received a median number of 5 (1–13) pulses of intravenous cyclophosphamide every 28 (13–54) days with a mean dosage of 766 (600–1 200) mg and a mean cumulative dosage of 4 500 (750–9 750) mg. Clinical activity, assessed by the Harvey–Bradshaw Index (HBI), decreased under CPT (mean HBI before treatment 10 and mean HBI after final CPT 5). Systemic steroids could be reduced from 40 to 10 mg (mean) qd over all patients. In 25% of the patients, remission (HBI <5) was achieved. Side effects were recorded in 75% (n = 29) of the patients. Common side effects were nausea and vomiting (65%), fatigue (12%), and sleep disorder (12%). Leukopenia or infectious complications developed in 2% and 10%, respectively. Treatment was terminated in 3 patients (7%) because of serious side effects, and none of the patients died.

Conclusion

Our data provide additional evidence for CPT as therapeutic alternative for induction of remission in patients with severe CD refractory to conventional therapies including TNF antibodies. CPT might serve as bridging for maintenance treatment. CPT given as pulse was rarely accompanied by serious side effects, and termination of the therapy was only necessary as the exception.