No abstract

BACKGROUND: In recent years, a number of therapeutic drug for patients with ulcerative colitis (UC) has been developed. Meanwhile, 5-aminosalicylic acid (5-ASA) has few serious adverse events, and remains as the first-line drug in induction therapy and maintenance therapy for UC. However, 5-ASA often cause diarrhea, fever and skin rash, and it is often difficult to maintain remission in these cases. There are few studies about the effect of 5-ASA intolerance on the prognosis of patients with UC. In this study, we aimed to clarify the optimal treatment strategy for patients with 5-ASA intolerance by examining the 5-ASA intolerance using the IBD registry of our hospital. METHODS: A multi-center retrospective cohort study of UC patients, who visited our hospital from January 2015 to June 2018, was performed, and we enrolled 793 UC patients in IBD registry. We collected the detail clinical information of enrolled patients in the prior year, and the primary outcome was hospitalization. Risk factors for hospitalization were assessed by binary logistic regression analysis. This study was approved by the ethics committee of Keio University School of Medicine (approval number: 20160038). RESULTS: We defined 5-ASA intolerance as patients who had at least one in the following symptoms due to 5-ASA administration; headache, gastrointestinal symptoms, cutaneous symptoms, and fever. The rates of 5-ASA intolerance were 28.5% (22/77) in admission group and 5.1% (37/716) in no admission group. Our multivariate analysis showed that the following 3 factors have significant correlations with hospitalization; 5-ASA intolerance (odds ratio (OR) = 5.46, 95% confidence interval (CI) = 2.20–13.5), extent of disease (OR = 9.47, 95% CI = 1.25–71.6), and serum albumin level (OR = 0.122, 95% CI = 0.07–0.20). On the other hand, IM intolerance, age, duration of disease, and 5-ASA non-administration were not significantly correlated with hospitalization. Furthermore, compared with 5-ASA tolerance group, the intolerance group had significantly greater incidences of corticosteroid usage (P < 0.001) and calcineurin inhibitor usage (P < 0.01). CONCLUSION(S): It became clear for the first time that 5-ASA intolerance is the risk factor for hospitalization and worsen the prognosis of patients with UC. Therefore, even when we encounter patients with UC who are intolerant to one of the 5-ASAs, switching to another 5-ASA and continuing 5-ASA administration under strict observation may improve the prognosis of patients with UC.