Background: The reliability of clinical judgment for the tapering of glucocorticoids in patients with active inflammatory bowel disease has been questioned.
Methods: The current study compared decision-making strategies on the basis of a combination of disease indices and serum concentrations of orosomucoid (strategy A) and disease indices only (strategy B) for the tapering of prednisolone. Twenty-nine patients with clinically active ulcerative colitis and 59 patients with Crohn's disease and increased concentrations of S-orosomucoid participated. The initial dose of prednisolone was 40 or 75 mg, which was tapered off over a minimum of 6 or 8 weeks.
Results: The tapering schedule was completed in 11 of 44 (25%) patients treated in accordance with strategy A, whereas 28 of 44 patients (64%) and prednisolone completely tapered, in accordance with strategy B. At follow-up 4 of 11 patients (36%) and 17 of 28 patients (61%) treated in accordance with strategies A and B, respectively, had clinical relapse (0.10 > P > 0.05). By means of multiple regression analysis a high serum concentration of orosomucoid and previous disease activity were identified as predictors of relapse.
Conclusion: A therapeutic end-point of normalization of an increased level of S-orosomucoid in addition to clinical remission may be difficult to use, as serum concentrations may be continuously increased in spite of clinical remission. However, this goal may still be relevant, as a trend towards higher risk of relapse was found in patients with increased orosomucoid concentrations after completing therapy.