Abstract
Purpose: To examine impact of IFX on UC-related hospitalizations (HOSP) in ACT 1 and HOSP requiring high-dose corticosteroids (CS) in ACT 1 & ACT 2. Methods: 728 pts in ACT 1&2 received PBO or IFX 5 or 10 mg/kg at baseline and at wks 2, 6, and q8 wks through wk 22 in ACT 2 and wk 46 in ACT 1. HOSP requiring IV/oral CS ≥ 40mg were compared for 30 wks in the ACT 1 and 2 combined data and for 54 wks in ACT 1, as surrogate of acute severe flare of UC. For ACT 1 54 wk, the # of HOSP was compared between treamtment grps, and between non-responders, responders not in remission, and pts in remission at wk 54. ANOVA on van der Waerden scores was used to compare # of HOSP and chi-square test was used to compare percentages. Results: In ACT 1, wk 54 responses in the combined IFX vs PBO grps were 44.9% vs 19.8%(p < 0.001); remission rates were 34.6% vs 16.5% (p < 0.001). Mean HOSP duration was 14 days; 50% of HOSP occurred within 41 days of baseline; 67.9% of HOSP involved UC-related surgeries/procedures. Reduction of HOSP was sustained through 1yr in ACT 1, with approx 50% lower mean # of HOSP in the combined IFX grp vs PBO (12 vs 22 per 100 pts, p= 0.061). Time to first HOSP was longer in the combined IFX grp vs PBO (p= 0.032). At wk 54, pts in remission and pts in response but not in remission had lower mean # of HOSP (0 and 0 per 100 pts) vs non-responders (23 per 100 pts; p < 0.001). Table 1 shows fewer HOSP with high-dose CS in combined IFX grp vs PBO. Through 54 wks of ACT 1 and 30 wks of ACT 2, 32 pts had HOSP and required high-dose CS; 11 of which had colectomy.Table: Demographics and Outcomes.Conclusions: IFX through 1yr sustained the reduction in UC-related HOSP observed through 30 wks of treatment, and showed fewer UC-related HOSP requiring CS≥ 40mg through 30 wks and 1yr. Responders and pts in remission at wk 54 had no UC-related hospitalizations through 1yr, while non-responders had a substantial number of UC-related HOSP.
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