P405. Mucosal healing in patients with ulcerative colitis treated with infliximab. What happens after treatment is discontinued?
C. Muñoz Villafranca, M.T. Bravo Rodríguez, J. Ortiz de Zárate, P. Arreba González, I. García Kamiruaga, J. Heras Martín, P. Cabezudo Gil, V. Orive Cura, Hospital universitario de Basurto, Aparato digestivo, Bilbao, Spain
Infliximab is an effective for the treatment of ulcerative colitis (UC). However, we know relatively little about the role of mucosa healing (MH) in the course of the disease or what happens after the treatment is discontinued.
Aim: To assess MH in patients with UC after one year of treatment with infliximab and the course of the disease after the discontinuation of infliximab.
We conducted a prospective observational study in patients with moderate-to-severe steroid resistant/dependent UC naïve to anti-TNF. Patients were treated with infliximab at a dose of 5 mg/kg at 0, 2, and 6 weeks, and then, at least, every 8 weeks until week 54. The Mayo scoring system was used to assess disease activity, while mucosal status was assessed using the Mayo endoscopic subscore (0–3). At this point, infliximab was discontinued in patients with MH and they were followed-up for at least 12 months (12–48). We defined clinical remission (CR) as a Mayo score <2; clinical response as a drop of at least 3 points in this score; and MH as a subscore of 0–1. Statistical analysis was performed with SPSS 20, using the Chi-square test for univariate analysis and Pearson's correlation for dependant variables. In patients with MH, we plotted Kaplan–Meier curves.
Of 21 patients recruited, 19 completed the study (in one case a colectomy and another was a non-responder). Among these patients, the mean age was 47.79 years old (31–82) and 12 were men. Ulcerative colitis was severe in 13 patients and moderate in 6, while the majority (11) was steroid resistant. More than half (57.8%) received combined treatments with immunosuppressive and in 31.5% the Infliximab treatment was intensified. At week 54, 16 patients (84.2%) had a clinical response, 13 were in CR (68.4%) and 12 (63.2%) showed MH. Significant associations were found between the dependent variables (CR and MH) and both clinical response (p < 0.05) and PCR results (p < 0.01), while treatment intensification was a predictor of non-response (p < 0.01). The correlation coefficient between CR and MH was 0.854 (p < 0.05).
Among the 12 patients with MH at week 54, 6 had new episodes of UC; 3 (25%) were treated again with infliximab, all within the first 12 weeks and all responded. With respect to discontinuation of infliximab, the percentage of patients who were treatment free was 91.7% at week 8, and 75% from week 12 to 24 months of follow-up. None of the patients required hospital admission or surgery.
Infliximab is an effective drug to treat UC and achieve MH. There is a positive relationship between disease activity and mucosal status.
Patients with MH after one year of treatment with infliximab had a good clinical course following treatment discontinuation.