Abstract

Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by periods of remission and periods of relapse. Up to 25% of the patients in clinical remission will present with disease relapse over a 6-month period. Most studies determining risk factors for clinical relapse are retrospective and performed over an extended period of time, being subject to selection, report and intervention bias. We aimed to prospectively identify clinical, analytical and endoscopic variables associated with an increased risk of short-term clinical relapse in corticosteroid-free remission UC patients. Prospective, observational study, including consecutive patients previously diagnosed with UC observed in our institution at scheduled consultations. During enrollment, only patients currently under medication for UC, in sustained corticosteroid-free remission and minimum follow-up of 6 months were included. Clinical and analytical variables were registered at enrollment, as well as recent (<6 months) endoscopic studies performed during clinical remission, current medication, and patient-reported adherence to prescribed medication. Patients were prospectively followed for 6 months, and clinical relapse (defined as the need to change or intensify treatment, hospitalization or surgery) was assessed. Statistical analysis was performed using SPSS v21.0, using univariate analysis with chi-square-test and independent-samples t-test; P value <0.05 was considered statistically significant. Included 135 patients, 56.3% female, mean age 44 (±13) years, and mean disease duration 6.4 (±4.8) years. Most patients (73%) were non-smokers, 20% were former smokers and 7% were smokers; familial history of IBD was present in 12% of the enrolled patients. Mean laboratorial values were within the normal range, except for slightly elevated c-reactive protein levels (7.9 ± 6.2 mg/L). The Mayo endoscopic score was ≤1 in 65% of the patients, and >1 in 35%. Disease extent was classified as proctitis in 47% of the patients, left-sided colitis in 35% and extensive colitis in 18%. Patients' medication included aminosalicylates in 91% of the cases, thiopurines in 17% and anti-TNFα agents in 13%. During follow-up, clinical relapse was observed in 14.1% (n = 19) of the patients. Age at enrollment <40 years (21.8% versus 8.8%, P = 0.032), disease duration <8 years (17.3% versus 3.2%, P = 0.048), disease flare during the previous year (40.0% versus 12.0%, P = 0.034), Mayo endoscopic Score >1 (50.0% versus 3.1%, P < 0.001) and partial or non-adherence to prescribed medication (30.0% versus 11.3%, P = 0.038) were significantly associated with an increased risk of clinical relapse during follow-up. The risk of relapse at 6 months was not associated with smoking status, disease extent, familial history of IBD, prescribed medication for UC or any analyzed laboratorial variable. In this prospective, observational study, there was a 15% incidence of clinical relapse at 6 months. This risk was significantly increased in younger patients (P = 0.032) with a shorter disease duration (P = 0.048), patients with recent disease flares (P = 0.034) or non-adherent to medication (P = 0.038), as well as patients where mucosal healing was not achieved (P < 0.001). In these patients in clinical remission, a lower threshold to intensify or change medication should be considered, and the importance of adherence to treatment should be reinforced.

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