Patient selection - Crohn's disease with:
(1) first course of corticosteroid therapy
(2) clinical remission achieved with an oral dose of 0.8 to 1.0 mg prednisone per kg per day
(3) gradual tapering of corticosteroid dose over 12 to 16 weeks
(4) maintenance on oral aminosalicylic acid 2.4 to 4.0 grams per day
Endpoint: Clinical relapse within 12 months of achieving the remission. A moderate or severe relapse was defined as the need for a second course of corticosteroid therapy
Risk factors for moderate to severe relapse:
(1) elevated C-reactive protein (CRP) at the time of steroid weaning (> 5 mg/L)
(2) penetrating complications (fistulizing, such as perianal disease)
where:
• The odds ratios for relapse were 5.6 (CRP) and 4.2 (fistulizing complications).
• One third of patients had a moderate to severe relapse within 12 months. One third of these occurred within the first 6 months and two thirds during the second 6 months.
• Adherence to the oral aminosalicylic acid would affect risk.
