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P436. Intravenous cyclophosphamide combined with thalidomide has a promising effect in refractory Crohn's disease

J. Tang, X. Gao, M. Zhi, H. Zhou, M. Zhang, H. Chen, Q. Yang, Z. Liang, The Sixth Affiliated Hospital of Sun Yat-sen University, Department of Gastroenterology, Guangzhou, China


In refractory Crohn's disease, established therapies fail in a relevant proportion of patients. In recent studies, both intravenous cyclophosphamide and thalidomide showed efficacy in these patients [1,2].


Fifteen patients with refractory Crohn's disease participated in this prospective open-labelled uncontrolled pilot study. All patients were treated with intravenous cyclophosphamide (200 mg qod × 2 weeks followed by 400 mg per week until reached a total dose of 6.0–8.0 g), and combined thalidomide (25–75 mg per day based on the tolerance of patients) for 3–4 months.


Nine of 15 patients were steroid-refractory and the others were steroid-dependent. Four patients were ineffective to infliximab therapy. Ten of 15 patients (67%) achieved remission within 2 weeks after cyclophosphamide and thalidomide therapy, with a Crohn's Disease Activity Index (CDAI) declined from 238 to 135 (median). At week 10 after initiation therapy, the clinical remission rate was 86% (12/14). When finished a total dose of 6.0–8.0 g cyclophosphamide, twelve of 14 patients had endoscopic improvement with Simple Endoscopic Score for Crohn's Disease (SESCD) declined from 9.4 to 4.7 (median).

Among them four patients reached muscle healing.

33% (5/15) patients suffered adverse event. Three had mild increase in aminotransferases (range: 62–144, median: 82) and one had leukemia. Only one patient quit the treatment because of serious urinary infection at week 2 after initiating cyclophosphamide therapy.

Figure 1. (A) CDAI after initiation intravenous cyclophosphamide and oral thalidomide therapy (n = 15). (B) SESCD after initiation intravenous cyclophosphamide and oral thalidomide therapy (n = 14).

Figure 2. Muscle healing after 3 months of intravenous cyclophosphamide and oral thalidomide therapy. (A,B) Healing of esophagus ulcerations. (C,D) Healing of colonic ulcerations.


In refractory Crohn's disease, intravenous cyclophosphamide combined with oral thalidomide may be a promising therapeutic option for not only clinical remission inducing but endoscopic improvement. Adverse events of this regime are not rare and should be monitored carefully.

1. A Stallmach, B M Wittig, C Moser et al. (2003), Safety and efficacy of intravenous pulse cyclophosphamide in acute steroid refractory inflammatory bowel disease, Gut.

2. K. J. Schmidt, K. Fellermann, P. Wellhöner et al. (2009), Clinical trial: cyclophosphamide pulse therapy - a promising therapeutic alternative in refractory Crohn's disease, Alimentary Pharmacology & Therapeutics.