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P203. A post-hoc analysis: Mucosal healing in patients with ulcerative colitis associates with a reduced colectomy risk, high incidence of corticosteroid-free state and corticosteroid-free symptomatic remission

W.J. Sandborn1, P. Rutgeerts2, W. Reinisch3, D. Esser4, Y. Wang5, Y. Lang6, C. Marano6, R. Strauss6, B.J. Oddens7, B. Feagan8, S.B. Hanauer9, G.R. Lichtenstein10, D. Present11, B.E. Sands11, J. Colombel12

1Mayo Clinic, Rochester, MN, United States; 2University Hospital Gasthuisberg, Leuven, Belgium; 3University Hospital Vienna, Wien, Austria; 4Centocor BV, Leiden, The Netherlands; 5Schering Corp, Kenilworth, NJ, United States; 6Centocor R&D, Inc, Malvern, PA, United States; 7Schering Corp, Kenilworth, NJ, United States; 8Robarts Research Institute, University of Western Ontario, Ontario, ON, Canada; 9University of Chicago, Chicago, IL, United States; 10University of Pennsylvania, Philadelphia, PA, United States; 11Mount Sinai Medical Center, New York, NY, United States; 12CHRU Lille, Lille, France

Aim: 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.

Materials and 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 log-rank 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 corticosteroid-free (CS-F) status and CS-F symptomatic remission (stool frequency score of 0/1 and a rectal bleeding score of 0) were assessed at wk 30 (ACT 1 and ACT 2 combined) and at wk 54 (ACT 1).

Table. Kaplan–Meier estimates of time to colectomy
Wk 8 endoscopy scoreNumber of colectomiesColectomy-free prob at wk 54 (%)p-value* (log rank)
Pts randomized to IFX (n = 466**)
 0 (n = 120)6950.0004
 1 (n = 175)895 
 2 (n = 114)1487 
 3 (n = 57)1080 
*p-value indicates the difference in distributions of time to colectomy among the 4 endoscopy score subgroups. **patients who had a colectomy or discontinued before wk 8 were not included.

Results: IFX patients who showed endoscopic improvement 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. Among those receiving corticosteroids prior to starting IFX-treatment, patients were more likely to be CS-F at wk 30 as their degree of MH improved at wk 8 (62% (0); 46% (1); 20% (2); 10% (3), p < 0.0001). IFX patients with lower endoscopy scores at wk 8 were more likely to be in CS-F symptomatic remission at wk 30 (46% (0); 34% (1); 11% (2); 6.4% (3), p < 0.0001). Similar trends in the attainment of a CS-F status and CS-F symptomatic remission were observed at wk 54 for IFX patients in ACT 1. Although a lower proportion of PBO patients became CS-F or achieved CS-F symptomatic remission 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.

Conclusion: 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 eliminating corticosteroids and achieving CS-F symptomatic remission.