EUROPEAN COOPERATIVE CROHNS-DISEASE STUDY (ECCDS) - RESULTS OF DRUG-TREATMENT

Abstract

A multicenter double-blind study of the effectiveness of sulfasalazine [SS] and 6-methylprednisolone [MP], alone and in combination, was conducted on 452 patients with Crohn''s disease. A total of 160 patients were previously untreated; 292 patients were previously treated. The Crohn''s disease activity index [CDAI] was used to determine whether a patient had active (CDAI .gtoreq. 150, n = 215) or quiescent disease (CDAI < 150, n = 237). Treatment of active disease consisted of high-dose MP, MP combined with 3 g of SS alone or placebo and lasted 6 wk. Patients in remission received maintenance doses of 1 of these drug regimens for periods of up to 2 yr. A total of 192 patients completed the 2-yr study period. Results were evaluated using life-table analysis and outcome ranking. These methods showed MP to be the most effective drug in overall comparison of all patients (P < 0.001): in previously treated patients (P < 0.001); and in subgroups: active disease (P < 0.001), ony small bowel disease (P < 0.05) and both small bowel and colon disease (P < 0.05). Combination of MP and SS was the most effective regimen in previously untreated patients (P < 0.05) and when disease was localized in the colon (P < 0.001). SS alone was least effective in overall comparison of all patients (P < 0.05) and in all strata. Drug treatment was of no significant benefit to patients with quiescent disease. Continuous administration of low doses of MP, or the combination regimen, was beneficial in patietns who responded initially to treatment of active disease. The addition of SS, however, offered no advantage.