It was found by the Japanese Researchers that over the last two years, the rate of relapse was relatively high in ulcerative colitis patients who receive the corticosteroid budesonide in topical rectal foam inclusive of those who previously had achieved full endoscopic healing after 6 weeks. Risk factors associated with the relapse were lower body weight and shorter disease duration, the ESCORT study group reported.
The Managing Director at the Keio School of Medicine in Tokyo, Makoto Naganuma and his colleagues stated that the treatment for maintaining remissions, such as strict follow-up and continuous use of topical therapy might be needed for patients with risk factors for relapse.
The observational study which took place at multiple centers was published in PLOS One. A total of 84 patients were enrolled who had achieved both clinical remissions, as well as, mucosal healing in previous phase II and phase III clinical trials. Out of the final 60 participants who were analyzed in the current study, 30.0% which is equivalent to 18 people had no relapse during the two-year follow-up.
The survival time of average relapse-free survival was 0.82 years (95 percent CI 0.51 to 1.52). Of 37 patients with a Mayo endoscopic subscore of 0 after achieving remission with budesonide foam, 67.6% which is equivalent to 25 relapsed within two years.
Patients who have less than 1 year of disease duration had a worse clinical outcome than those whose duration of the disease was over 5 years, for a hazard ratio of 2.38 (95 percent CI 1.04 to 5.45).
There were several limitations to the study, the researchers told, inclusive of the small sample size and its retrospective nature. Moreover, relapse by clinical parameters exclusively was assessed and didn’t use objective biomarkers of inflammation like fecal calprotectin.