Open AccessMiddle-term prognosis in patients with ulcerative colitis who achieved clinical and endoscopic remission by budesonide rectal foam
Author(s) -
Makoto Naganuma,
Fumihito Hirai,
Kiyonori Kobayashi,
Kenji Watanabe,
Ken Takeuchi,
Nobuo Aoyama,
Hiroshi Nozawa,
Satoshi Motoya,
Toshihide Ohmori,
Akio Harada,
Yushi Nagai,
Takayuki Abe,
Yoji Yamada,
Kiyokazu Inagaki,
Naoki Shimizu,
Takanori Kanai,
Mamoru Watanabe
Publication year - 2019
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0220413
Subject(s) - medicine , budesonide , ulcerative colitis , gastroenterology , hazard ratio , confidence interval , retrospective cohort study , surgery , disease , corticosteroid
Background Budesonide foam is effective in inducing clinical remission in ulcerative colitis (UC) patients with active proctosigmoiditis. The aim of this study was to evaluate the duration of remission and predictors of relapse in UC patients who achieved clinical remission and mucosal healing by 6-week treatment with topical budesonide. Methods This is a retrospective, observational, multicenter study with a 2-year follow-up period. UC patients who were treated with budesonide foam in phase 2 or phase 3 clinical trials and achieved both clinical remission and mucosal healing were enrolled. Results Among 84 patients who met the eligibility criteria, 60 participated in the study. Eighteen of the 60 patients (30.0%; 95% confidence interval [CI]: 18.9–43.2) experienced no relapse (i.e., maintenance of remission) during the 2-year follow-up period. The median relapse-free survival time was 0.82 years (95% CI: 0.51–1.52). Of 37 patients with a Mayo endoscopic subscore of 0 after inducing remission with budesonide foam, 25 (67.6%) relapsed within 2 years. Patients with a disease duration of <1 year experienced a worse clinical outcome than patients with a disease duration of >5 years, and the hazard ratio was 2.38 (95% CI: 1.04–5.45). Conclusion This is the first study to evaluate the short- to middle-term prognosis in UC patients who achieved mucosal healing with topical preparations. After inducing remission by budesonide foam, treatment for maintaining remissions and strict follow-up may be needed for patients with shorter disease duration.