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P654 Mucosal healing with a second anti-TNF-α in patients with ulcerative colitis after the failure of the previous anti-TNF-α treatment

Papa A., Pugliese D., D'Aversa F., De Vitis I., Landi R., Guidi L., Felice C., Gerardi V., Armuzzi A., Gasbarrini A., Rapaccini G.L.

Catholic University of Rome, Fondazione Policlinico Gemelli, Internal Medicine and Gastroenterology, Roma, Italy

Background

Anti-tumor necrosis factors (TNF)-α agents represent an effective treatment for ulcerative colitis (UC) patients. Indeed, infliximab (IFX), adalimumab (ADA) and golimumab (GOL) have demonstrated in clinical trials to obtain not only clinical remission but also mucosal healing (MH) in UC patients with significantly higher rates compared to placebo. However, in patients not-naïve to anti-TNF-α treatment the efficacy of a second agent of the same pharmacological class has not been properly assessed. Aim of this study was to evaluate in a cohort of UC patients the rate of MH obtained after the switch to a different anti-TNF-α agent.

Methods

UC patients consecutively treated with two different anti-TNF-α agents were considered. Only patients who underwent to at least three colonoscopies in order to assess endoscopic activity and MH were included. In detail, the first colonoscopy was performed before starting the first anti-TNF-α (baseline), the second during the first anti-TNF-α course (1st MH assessment) and the third colonoscopy during the second anti-TNF-α course (2nd MH assessment). When more than a colonoscopy was performed after the start of the anti-TNF-α agent course the earlier exam was considered for assessing MH.Endoscopic activity was assessed by means of Mayo endoscopic score. MH was defined for a Mayo score of 0 or 1.

Results

During the study period, 42 UC patients were treated with two different anti-TNF-α agents. Of these, 14 resulted eligible for the study according to the inclusion criteria. Eight patients were males, mean age was 30 years old (range 16–49), 11 patients had pancolitis and 3 left colitis. At baseline colonoscopy all patients had endoscopic activity: 6 Mayo score 2 and 8 Mayo score 3. For 13/14 patients (93%) the first anti-TNF-α used was IFX and in 1 patient GOL. After the first course of anti-TNF-α 2/14 patients (14%) improved the endoscopic appearance, but only 1 obtain MH. The indication for switching to the second anti-TNF-α was primary non response in 3 pts (21.4%), loss of response in 6 (42.8%) and intolerance to treatment in 5 (35.7%). The second anti-TNF-α agent used was ADA for 10 patients, GOL for 3 and IFX for 1. After the second course with a different anti-TNF-α, 4/14 (28.5%) patients obtained MH (3 with ADA and 1 with GOL). Of the patients with MH 2 were intolerant to the first anti-TNF-α (2/5, 40%) and 2 had loss of response before switching (2/6, 33.3%).

Conclusion

The findings of this study, for the first time in real life practice, showed that the switch to a second anti-TNF-α agent allows obtaining MH in almost a third of patients with UC, particularly in those intolerant to the first anti-TNF-α. Further studies in larger cohort of patients are needed to confirm these data.