Purpose: To assess whether there is an association between degree of mucosal healing (MH) at wk 8 and clinical outcomes in patients with moderate-to-severe ulcerative colitis (UC) in ACT1 and ACT2. Methods: MH at wk 8 was assessed using the Mayo endoscopic subscore classification (0-normal, 1-mild, 2-moderate, 3-severe disease). A post-hoc logrank test was used to examine the distribution of time to colectomy through wk 54 across the 4 endoscopy subgroups for IFX and PBO-treated patients, respectively (ACT 1 and ACT 2 combined). The proportion of patients with symptomatic remission (stool frequency score of 0/1 and a rectal bleeding score of 0) and corticosteroid-free status were assessed at wk 30 (ACT 1 and ACT 2 combined) and at wk 54 (ACT 1). Results: IFX patients who had endoscopy subscores of 0 or 1 at wk 8 were less likely to progress to colectomy through wk 54 (Table; p=0.0004). Small event numbers in PBO patients precluded a clear conclusion for PBO. IFX patients with lower endoscopy scores at wk 8 were more likely to be in symptomatic remission at wk 30 (71% (0); 51% (1); 23% (2); 10% (3), p<0.0001). Among those receiving corticosteroids prior to starting IFX-treatment, patients were more likely to be corticosteroid-free at wk 30 as their degree of MH improved at wk 8 (62% (0); 46% (1); 20% (2); 10% (3), p<0.0001). Similar trends in symptomatic remission and the attainment of a corticosteroid-free status were observed at wk 54 for IFX patients in ACT 1. Although a lower proportion of PBO patients achieved symptomatic remission or became corticosteroid-free vs. IFX patients, similar trends of improved outcomes at wks 30 and 54 were associated with the degree of MH attained by PBO patients at wk 8.[1200] Table. Kaplan-Meier estimates of time to colectomyConclusion: Patients with moderate-to-severe UC, who achieve early mucosal healing, are less likely to go on to colectomy through 1 year of follow-up. Improved endoscopic outcomes were associated with a greater likelihood of achieving symptomatic remission and eliminating corticosteroids. Disclosure: Dr Sandborn-Investigator, Centocor R&D, Inc Dr Rutgeerts-Investigator, Centocor R&D, Inc Dr Reinisch-Investigator, Centocor R&D, Inc Dr Esser-Employee-Centocor BV Drs Wang and Oddens-Employees-Schering Corp Drs Lang, Marano, Strauss-Employees-Centocor R&D, Inc Dr Feagan-Investigator, Centocor R&D, Inc Dr Hanauer-Investigator, Centocor R&D, Inc Dr Lichtenstein-Investigator, Centocor R&D, Inc Dr Present-Investigator, Centocor R&D, Inc Dr Sands-Investigator, Centocor R&D, Inc Dr Colombel-Investigator, Centocor R&D, Inc. This research was supported by an industry grant from Centocor R&D, Inc.
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Sandborn et al. (2010) studied this question.