Background: Ulcerative colitis (UC) is a potentially severe disease that carries an increased risk of complications and colectomy. Immunosuppressant and biological therapies are relevant tools for complex patients. The ACCENT study showed that in Crohn's disease (CD) scheduled infliximab (IFX) infusions vs. episodic are associated with greater efficacy. In UC, historical difficulties of economic access had conditioned to our IBD center, to use IFX in moderate to severe UC as a bridge to thiopurines in pts 6mp/aza naïve. In UC, the mentioned strategy was insufficiently compared with a regimen of scheduled IFX treatment, that currently we use. Aims: to compare (retrospectively) in moderate to severe UC the results of induction with IFX (in thiopurine naïve pts) continuing with 6mp/aza maintenance vs. similar induction followed by scheduled IFX maintenance strategy.
Methods: We included a cohort of moderate to severe UC treated with IFX in an IBD center (2006 to 2015) comparing results between IFX bridge followed by thiopurines (re-induction when available for moderate to severe relapse) vs. scheduled IFX (induction 0, 2, 6 wks and 8 wks' interval infusions maintenance). Optimization (by frequency of intervals) were allowed in both modalities. Comparisons: Kaplan Meier/Log rank test: a) Cumulative prevalence of colectomy, b) survival times relapse free, c) survival times corticosteroid free.
Results: We identified 135 UC (M 60, F 75, Age (mean±SD) 35.9±13.2, UC duration 5.8±5.9 yrs, Extent: extensive 58.5%, Left-sided 41.5%, Activity: severe 78.5%, moderate 21.5%, mean Mayo sc. 10.1±1.8. Primary no responders at week 12 (n 25: 18,5%) were not considered in maintenance comparisons, performed in 110/135 pts (follow-up 37.5±24.0 months) Groups: IFX bridge (n=51) and scheduled IFX (n 59) were not different in extent, age, UC duration, Mayo sc. Cumulative prevalence of colectomy was significantly lower in the scheduled strategy (HR: 6.8805, 95% CI 1.7207 to 27.5133, p=0.0349), as well as survival times free of relapse (HR 3.1026, 95% CI 1,8368 to 5.2405, p<0.0001) and free of corticosteroids (HR 2.6057, 95% CI 1.5516 to 4.3757, p=0.0003. A proportion of UC significantly higher within the re-induced pts (IFX bridge) required a shift of biological drug compared with the scheduled strategy (p=0.016, Fisher), despite of similar rates of optimization. Infusion reactions needing definitive IFX suspension were more frequent as a tended (p=0.06) in re-induced pts.
Conclusions: similarly to was described for CD pts, in the CU, the scheduled IFX treatment strategy regimen, after a moderate-severe outbreak, seem to be associated with better long-term outcome regarding colectomy requirement, relapses, and need for corticosteroids, compared with a bridge IFX strategy followed by thiopurines.