Twice-daily Budesonide 2-mg Foam Induces Complete Mucosal Healing in Patients with Distal Ulcerative Colitis.

Abstract

BACKGROUND AND AIMS:

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: Makoto Naganuma, Nobuo Aoyama, Yasuo Suzuki, Haruo Nishino, Kiyonori Kobayashi, Fumihito Hirai, Kenji Watanabe, Toshifumi Hibi
• Journal: Journal of Crohn's & colitis (J Crohns Colitis) Vol. 10 Issue 7 Pg. 828-36 (Jul 2016) ISSN: 1876-4479 [Electronic] England
• PMID: 26577683 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © European Crohn’s and Colitis Organisation 2015.

Chemical References

• Anti-Inflammatory Agents
• Budesonide

Topics

• Administration, Rectal
• Adolescent
• Adult
• Aged
• Anti-Inflammatory Agents (administration & dosage, therapeutic use)
• Budesonide (administration & dosage, therapeutic use)
• Colitis, Ulcerative (diagnostic imaging, drug therapy, pathology)
• Colon (diagnostic imaging, pathology)
• Colonoscopy
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Induction Chemotherapy (methods)
• Intestinal Mucosa (diagnostic imaging, pathology)
• Male
• Middle Aged
• Treatment Outcome
• Wound Healing
• Young Adult