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Inflammatory bowel disease
Switch from systemic steroids to budesonide in steroid dependent patients with inactive Crohn's disease
  1. A Cortota,
  2. J-F Colombela,
  3. P Rutgeertsb,
  4. K Lauritsenc,
  5. H Malchowd,
  6. J Hämlinge,
  7. T Winterf,
  8. A Van Gossumg,
  9. T Perssonh,
  10. E Pettersson for the International Budesonide Study Grouph,†
  1. aService de Gastroenterologie, Hôpital Claude Huriez, Lille, France, bDepartment of Gastroenterology, University Hospital of Leuven, Belgium, cDepartment of Medical Gastroenterology, University Hospital of Odense, Denmark, dMedizinische Klinik II, Städtisches Krankenhaus Leverkusen, Germany, eKrankenhaus Tabea, Hamburg, Germany, fDepartment of Gastroenterology, Groote Schuur Hospital, Cape Town, South Africa, gService de Gastroentérologie, Hôpital Erasme, Bruxelles, Belgium, hClinical Research and Development, AstraZeneca R&D, Lund, Sweden
  1. A Cortot, Service de Gastroenterologie, Hôpital Claude Huriez F-59037 Lille, France.a-cortot{at}chru-lille.fr

Abstract

BACKGROUND Steroid dependent patients with Crohn's disease are at high risk of developing glucocorticosteroid induced side effects.

AIMS We evaluated the possibility of switching from systemic steroids to budesonide (Entocort) in prednisolone/prednisone dependent patients with inactive Crohn's disease affecting the ileum and/or ascending colon.

PATIENTS Steroid dependent patients with a Crohn's disease activity index ⩽200 were included.

METHODS In a double blind multicentre trial, 120 patients were randomly assigned to receive budesonide 6 mg once daily or placebo. Prednisolone was tapered to zero during the first 4–10 weeks and budesonide or placebo was given concomitantly and for a further 12 weeks. Relapse was defined as an index >200 and an increase of 60 points from baseline or withdrawal due to disease deterioration.

RESULTS After one and 13 weeks without prednisolone, relapse rates were 17% and 32%, respectively, in the budesonide group, and 41% and 65% in the placebo group (95% confidence intervals for the difference in percentages −41%, −8% and −51%, −16%; p=0.004 and p<0.001, respectively). The number of glucocorticosteroid side effects was reduced by 50% by switching from prednisolone and was similar in the budesonide and placebo groups. Basal plasma cortisol increased in both groups.

CONCLUSIONS The majority of patients with steroid dependent ileocaecal Crohn's disease may be switched to budesonide controlled ileal release capsules 6 mg without relapse, resulting in a sharp decrease in glucocorticosteroid side effects similar to placebo, and with an increase in plasma cortisol levels.

  • budesonide
  • Crohn's disease
  • steroid dependent
  • prednisolone

  • Abbreviations used in this paper

    5-ASA
    5-aminosalicylate
    CD
    Crohn's disease
    CDAI
    Crohn's disease activity index
    CIR
    controlled ileal release
    GCS
    glucocorticosteroids
    IBDQ
    inflammatory bowel disease questionnaire
    QoL
    quality of life

    • https://doi.org/10.1136/gut.48.2.186

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    • Abbreviations used in this paper

      5-ASA
      5-aminosalicylate
      CD
      Crohn's disease
      CDAI
      Crohn's disease activity index
      CIR
      controlled ileal release
      GCS
      glucocorticosteroids
      IBDQ
      inflammatory bowel disease questionnaire
      QoL
      quality of life
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