title: Twice-daily Budesonide 2-mg Foam Induces Complete Mucosal Healing in Patients with Distal Ulcerative Colitis.
abstract: OBJECTIVE
  Mucosal healing is an important therapeutic goal for ulcerative colitis. Once-daily administration of budesonide 2-mg foam is widely used for inducing clinical remission. No study has assessed the usefulness of twice-daily budesonide 2mg foam on mucosal healing in ulcerative colitis patients. We explored the efficacy for mucosal healing of once- or twice-daily budesonide foam in distal ulcerative colitis patients.
  
  
  METHODS
  This study was a multicentre, randomised, double-blind, placebo-controlled trial. In all, 165 patients with active, mild to moderate distal ulcerative colitis were randomised to three groups: once- or twice-daily budesonide 2mg/25ml foam, or placebo foam, for 6 weeks. Complete mucosal healing [endoscopic subscore = 0] and the safety profile were assessed at Week 6. Prespecified and post hoc analyses were used.
  
  
  RESULTS
  The percentages of complete mucosal healing in the twice-daily budesonide foam group were 46.4% compared with 23.6% in the once-daily group [p = 0.0097], or 5.6% in the placebo group [p < 0.0001]. The percentages of clinical remission and the percentages of endoscopic subscore ≤ 1 in the twice-daily budesonide foam group were 48.2% and 76.8%, compared with 50.9% and 69.1% in the once-daily group [no difference], or 20.4% and 46.3% in the placebo group [p = 0.0029 and p = 0.0007], respectively. In the subgroup of patients with previous use of a 5-aminosalicylic acid suppository or enema, there was a greater percentage of complete mucosal healing in the twice-daily budesonide foam group [32.0%] compared with that in the once-daily [8.7%, p = 0.0774] or placebo groups [4.8%, p = 0.0763], though there was no significant difference. No serious adverse event occurred.
  
  
  CONCLUSIONS
  A significantly greater percentage of patients receiving twice-daily administration of budesonide foam compared with once-daily administration/placebo achieved complete mucosal healing. This is the first study to evaluate the endoscopic efficacy of twice-daily administration of 6-week budesonide foam treatment for ulcerative colitis.
authors.affiliation: Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan maknaganuma@gmail.com.
authors.forename: Makoto
authors.initials: M
authors.lastname: Naganuma
authors.affiliation: Gastrointestinal Endoscopy and Inflammatory Bowel Disease Center, Aoyama Medical Clinic, Hyogo, Japan.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Aoyama
authors.affiliation: Department of Internal Medicine, Sakura Medical Center, Toho University, Chiba, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Suzuki
authors.affiliation: Colo-Proctology Center, Matsushima Clinic, Kanagawa, Japan.
authors.forename: Haruo
authors.initials: H
authors.lastname: Nishino
authors.affiliation: Department of Research and Development Center for New Medical Frontiers, School of Medicine, Kitasato University, Kanagawa, Japan.
authors.forename: Kiyonori
authors.initials: K
authors.lastname: Kobayashi
authors.affiliation: Department of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan.
authors.forename: Fumihito
authors.initials: F
authors.lastname: Hirai
authors.affiliation: Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Watanabe
authors.affiliation: Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan.
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
mesh_terms: D000285:Administration, Rectal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage* / Q000627:therapeutic use; D003093:Colitis, Ulcerative / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D003106:Colon / Q000000981:diagnostic imaging / Q000473:pathology*; D003113:Colonoscopy; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods*; D007413:Intestinal Mucosa / Q000000981:diagnostic imaging / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014945:Wound Healing; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D019819:Budesonide
keywords: Ulcerative colitis; budesonide foam; mucosal healing