Clinical trial: controlled, open, randomized multicenter trial comparing the effects of treatment on quality of life, safety and efficacy of budesonide and mesalazine enemas in active left-sided ulcerative colitis

Franz Hartmann (1) , Jürgen Stein (1, 2)

1 Colitis Crohn Clinical Research Center Rhein-Main
2 Gastroenterology and Clinical Nutrition

BACKGROUND: Therapy for left sided ulcerative colitis (UC) usually involves topical application of mesalazine or budesonide. AIM: To compare the efficacy and safety of budesonide enema and mesalazine enema in the treatment of active left sided ulcerative colitis METHODS: 237 patients with mild-moderate UC were randomized open 1:1 to receive either budesonide (n=118) or mesalazine enemas (n=119) for 8 weeks. Efficacy variables were clinical activity index (CAI), endoscopic, histological index and IBDQ scores after 4 and 8 weeks. RESULTS: Clinical remission (intention-to-treat analysis) at week 4 was 63.5 % for budesonide enemas and 77.2% for mesalalzine enemas (p<0.05). The respective values for the per protocol population (PP) were 59.9% examined in the budesonide group and 77.5% in the mesalazine group (p<0.02). At the final visit (W8), clinical remission was diagnosed in the ITT analysis for 64.4 % of the budesonide group and 77.4 % of the mesalazine group (p < 0.05). The respective values for the PP analysis were 59.5% in the budesonide group and 75.3% in the mesalazine group (p<0.02). CONCLUSIONS: Compared with budesonide, mesalazine enema was associated with a significantly higher remission rate, this was supported by favourable trends in endoscopic, histological remission rates and the IBDQ score.

Mots clés: Medicine

Franz Hartmann, Jürgen Stein. Clinical trial: controlled, open, randomized multicenter trial comparing the effects of treatment on quality of life, safety and efficacy of budesonide and mesalazine enemas in active left-sided ulcerative colitis. Alimentary Pharmacology and Therapeutics, 2010, 32 (3), pp.368. ⟨10.1111/j.1365-2036.2010.04354.x⟩. ⟨hal-00599508⟩