Crohn's disease: steroid-dependent: switching to budesonide reduced relapse rates compared with placebo

Clinical bottom line (level 1b)

  1. Patients with steroid-dependent inactive Crohn's disease who took budesonide during prednisolone-weaning compared with placebo were less likely to relapse (NNT = 3 at 13 weeks) , but not clearly more likely to have adverse effects.
Cortot et al: Gut 2001; 48 : 186-190
Expires May 2004

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: 24 acute hospitals, Europe and South Africa

120 patients (aged ?, -% male) with inactive Crohn's disease (CDAI 200 or less) on steroids. Patients had take prednisolone or prednisone 10-30 mg daily for at least 6 months, and had failed at least 2 attempts to taper the dose.

Excluded if
  • aged < 18
  • allergic to study drugs
  • major manifestation of Crohn's disease in the rectum
  • septic complications, abscesses, perforations or active fistulae
  • ileostomy, pouch or colostomy, resection of ileum > 100 cm
  • required immediate surgery
  • started immunosuppression within 6 months, or 5-ASA within 1 month
  • pregnant or breast-feeding

Control Group: (n = 60, 60 analysed): placebo
Experimental Group: (n = 60, 60 analysed): budesonide 6 mg daily
Patients tapered prednisolone on enrollment (5 mg per week until 20 mg and thereafter 2.5 mg per week)
98% followed for 13 weeks
Outcome notes:
  • relapse : CDAI > 200 and an increase of 60 points, or withdrawal due to clinical deterioration.

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
relapse 13 weeks 38
(63.3%)		 19
(31.7%)		 50%
(24% to 67%)		 31.7%
(14.7% to 48.6%)		 3
(2 to 7)

Comments

  1. Patients were randomised in blocks of four.
  2. Adverse effects were similar in both groups.

Citation

  1. Cortot A, Colombel J-F, Rutgeerts P, et al: switch from systemic steroids to budesonide in steroid dependent patients with inactive Crohn's disease. Gut 2001; 48 : 186-190
Search Terms: from ACP Journal Club other articles noted
Contributor: Chris Ball, May 2002
Reviewer:

Clinical Question.
Patient inactive Crohn's disease, but steroid-dependent
Intervention or Exposure budesonide and steroid-weaning
Comparison placebo and steroid-weaning
Outcome relapse