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* = Presenting author

P558 Twice-daily budesonide rectal foam induces complete mucosal healing in Japanese patients with mild to moderate ulcerative colitis: Results of multicenter, randomized, double-blind, placebo-controlled trial

N. Aoyama*1, Y. Suzuki2, H. Nishino3, K. Kobayashi4, F. Hirai5, K. Watanabe6, M. Naganuma7, T. Hibi8

1Aoyama Medical Clinic, GI Endoscopy & IBD Center, Kobe, Japan, 2Sakura Medical Center, Toho University, Department of Internal Medicine, Sakura, Japan, 3Matsushima Clinic, Colo-Proctology Center, Yokohama, Japan, 4Kitasato University, Department of Research and Development Center for New Medical Frontiers, Sagamihara, Japan, 5Fukuoka University Chikushi Hospital, Department of Gastroenterology, Chikushino, Japan, 6Osaka City General Hospital, Department of Gastroenterology, Osaka, Japan, 7Keio University, Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Tokyo, Japan, 8Kitasato University, Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Tokyo, Japan

Background

Budesonide rectal foam is widely used as effective, easy to use, well tolerated corticosteroid rectal preparation for ulcerative colitis (UC) in Europe. We evaluated the efficacy and safety of budesonide rectal foam in Japanese UC patients.

Methods

This study was multicenter, randomized, double-blind, placebo-controlled trial.165 patients with active, mild to moderate UC were randomized to three groups that were given budesonide foam (2mg/25mL) once or twice daily or placebo for 6 week. Primary endpoint was remission at 6 week (Rectal bleeding subscore=0, endoscopic subscore< =1 and stool frequency subscore=0 or decrease >=1).

Results

At week 6, the percentages of remission in once or twice daily budesonide foam group were 50.9% (95% CI 38.1 to 63.6), 48.2% (95% CI 35.7 to 61.0), respectively, compared with 20.4% (95% CI 11.8 to 32.9) in placebo group (P=.0015, P=.0029). The percentages of complete mucosal healing (endoscopic subscore=0) in once or twice daily budesonide foam group were 23.6% (95% CI 14.4 to 36.3), 46.4% (95% CI 34.0 to 59.3), respectively, compared with 5.6% (95% CI 1.9 to 15.1) in placebo group (P=.0159, P<.0001). No serious adverse event occurred in all groups. Blood cortisol decrease (<4ug/dL) occurred in 21.8% and 46.4% of once and twice daily budesonide foam groups, but all of them returned to normal level after treatment.

Conclusion

Budesonide rectal foam was effective to induce remission in Japanese patients without any serious problems. Especially, twice daily administration was highly effective to achieve complete mucosal healing.