Background: Mucosal healing has become a common endpoint in most ulcerative colitis (UC) clinical trials as well as an important objective in clinical practice. Mucosal healing in UC patients is associated with high rates of clinical remission and a favorable prognosis. MMX-mesalamine is a drug that due to its pharmacokinetics characteristics reaches more distal segments of the colon. Thus, it could be used in patients with intolerance to topical therapy. The aim of this study was to evaluate the efficacy of MMX-mesalamine for maintenance of remission in UC patients after mucosal healing.
Methods: A prospective, observational cohort study was designed. Consecutive UC patients with demonstrated mucosal healing at colonoscopy, and who were under monotherapy with MMX-mesalamine were included. Patients receiving additional topical therapy were excluded. Extension of the disease was classified according to the Montreal Classification. Mucosal healing was defined as endoscopic Mayo sub-score of 0 or 1. In order to avoid interpretation bias, all colonoscopies were performed and scored by the same endoscopist, who is an expert in IBD. Clinical relapse was defined as the need for remission induction treatment, any treatment escalation, hospitalization or colectomy. In order to assess the clinical course of UC, patients were followed-up and clinical relapses were evaluated at months 6 and 12 from initial colonoscopy. The influence of demographic and clinical variables (smoking, extension of disease and Mayo sub-score) in the clinical course of UC was also evaluated. Results are shown as percentages and analyzed by the chi-squared test and logistic regression.
Results: 57 UC patients fulfilled the inclusion criteria and were finally included. Mean age was 48 years (range 33–58), 58% women; 44% had never smoked, 19% were active smokers and 37% former smokers. 51% were E1, 26% were E2 and 23% were E3. Sixty-five percent had Mayo 1 and 35% had Mayo 0. During the first six months of follow-up 79.1% of patients remained in remission and 20.9% relapsed (mean time to relapse 14 weeks). Over the second semester, an additional 7% of patients relapsed. 10 out of the 12 patients who relapsed had a Mayo 1 sub-score. Frequency of relapses was not different in the different Montreal groups (p=0.78). 83% of former smokers patients presented a relapse compared to 17% of non-smokers (p=0.06).
Conclusions: MMX-mesalamine appears to be effective to maintain endoscopic remission in UC patients. Neither the extension of the disease nor the Mayo sub-score seem to influence the efficacy of the therapy in this study. Further studies including larger numbers of patients are required to confirm these data.