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Gut. Jul 2001; 49(1): 42–46.
PMCID: PMC1728363
Interleukin 10 (Tenovil) in the prevention of postoperative recurrence of Crohn's disease
J Colombel, P Rutgeerts, H Malchow, M Jacyna, O Nielsen, J Rask-Madsen, S Van Deventer, A Ferguson, P Desreumaux, A Forbes, K Geboes, L Melani, and M Cohard
Gastroenterology Unit, Hopital Claude Huriez, Lille, France. jfcolombel/at/chru-lille.fr
BACKGROUND AND AIMS—New lesions of Crohn's disease occur early after ileal or ileocolonic resection and ileocolonic anastomosis. We performed a double blind controlled trial to evaluate the safety and tolerance of recombinant human interleukin 10 (IL-10; Tenovil) in subjects operated on for Crohn's disease. We also assessed the effect of Tenovil in preventing endoscopic recurrence 12 weeks after surgery.
METHODS—Patients with Crohn's disease who underwent curative ileal or ileocolonic resection and primary anastomosis were randomised within two weeks after surgery to receive subcutaneous Tenovil 4 µg/kg once daily (QD) (n=22) or 8 µg/kg twice weekly (TIW) (n=21), or placebo (QD or TIW) (n=22). An ileocolonoscopy was performed after 12 weeks of treatment.
RESULTS—Compliance was excellent. The most frequently observed adverse events were mild and moderate in severity and equally distributed across treatment groups. Thirty seven patients in the pooled Tenovil group and 21 patients in the pooled placebo group were evaluable by endoscopy. At 12 weeks, 11 of 21 patients (52%) in the placebo group had recurrent lesions compared with 17 of 37 patients (46%) in the Tenovil group (ns). The incidence of severe endoscopic recurrence was similar in both groups (9%).
CONCLUSION—Tenovil treatment for 12 consecutive weeks in patients with Crohn's disease after intestinal resection was safe and well tolerated. No evidence of prevention of endoscopic recurrence of Crohn's disease by Tenovil was observed.


Keywords: Crohn's disease; interleukin 10; endoscopic recurrence
Figure 1
Figure 1  
Mean haemoglobin concentrations in the Tenovil (SCH 52000) 4 µg/kg once daily (QD) and 8 µg/kg twice weekly (TIW) treatment groups and in the pooled placebo group during the treatment and follow up phases of the study. (more ...)
Figure 2
Figure 2  
Ileal concentrations of interleukin 10 (IL-10) mRNA at surgery.
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