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Inflammatory bowel disease
Interleukin 10 (Tenovil) in the prevention of postoperative recurrence of Crohn's disease
  1. J-F Colombela,
  2. P Rutgeertsb,
  3. H Malchowc,
  4. M Jacynad,
  5. O H Nielsene,
  6. J Rask-Madsenf,
  7. S Van Deventerg,
  8. A Fergusonh,
  9. P Desreumauxa,
  10. A Forbesd,
  11. K Geboesi,
  12. L Melanij,
  13. M Cohardj
  1. aGastroenterology Unit, Hopital Claude Huriez, Lille, France, bDepartment of Medicine, University of Leuven, Leuven, Belgium, cKlinikum Leverkusen, Leverkusen, Germany, dDepartment of Gastroenterology, Harrow, UK, eDepartment of Gastroenterology, Glostrup, Denmark, fDepartment of Gastroenterology, Herlev, Denmark, gAcademic Medical Centre, Amsterdam, the Netherlands, hDepartment of Gastroenterology, Edinburgh, UK, iDepartment of Pathology, University of Leuven, Leuven, Belgium, jSchering-Plough Research Institute, Kenilworth, NJ, USA
  1. J F Colombel, Department of Gastroenterology, Hopital Huriez, CHU Lille, France.jfcolombel{at}chru-lille.fr

Abstract

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.

  • Crohn's disease
  • interleukin 10
  • endoscopic recurrence

  • Abbreviations used in this paper

    CD
    Crohn's disease
    IL
    interleukin
    IFN-γ
    interferon γ
    TNF-α
    tumour necrosis factor α
    QD
    once daily
    TIW
    twice weekly
    PCR
    polymerase chain reaction

    • https://doi.org/10.1136/gut.49.1.42

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    • Abbreviations used in this paper

      CD
      Crohn's disease
      IL
      interleukin
      IFN-γ
      interferon γ
      TNF-α
      tumour necrosis factor α
      QD
      once daily
      TIW
      twice weekly
      PCR
      polymerase chain reaction
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