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Budesonide foam with and without 5-ASA safely, effectively treated distal UC

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PHILADELPHIA — Budesonide rectal foam, a second-generation corticosteroid, demonstrated safety and efficacy in the treatment of patients with ulcerative proctitis or ulcerative proctosigmoiditis, regardless of oral 5-ASA use at baseline, according to phase 3 trial data presented at the ACG Annual Scientific Meeting.

William J. Sandborn, MD, of the University of California San Diego, and colleagues performed two identical phase 3 studies to evaluate the impact of oral 5-aminosalicylic acid (ASA) on the efficacy and safety of budesonide foam for treatment of distal ulcerative colitis (UC). The pooled analysis included data on patients with mild-to-moderate active ulcerative proctitis or ulcerative proctosigmoiditis who received 2mg/25mL budesonide foam twice daily for 2 weeks followed by 2 mg/25mL once daily for 4 weeks or placebo. Patients were permitted to continue stable oral 5-ASA of up to 4.8 g per day, but use of rectal 5-ASA was not permitted.

William J. Sandborn

Baseline 5-ASA use was reported in 55.1% of the 267 patients who received budesonide foam, and 55.2% of the 279 patients who received placebo. Remission at week 6 was achieved by 42.2% of the budesonide foam group who used 5-ASA compared with 31.8% of the placebo group who used 5-ASA (P=.0265), and by 40% of the budesonide foam users who did not use 5-ASA compared with 14.4% of the placebo group who did not use 5-ASA (P<.0001). Rectal bleeding scores of 0 at week 6 for the same subgroups were achieved by 50.3% vs. 35.7% (P=.0031) and 45.8% vs. 19.2% (P<.0001), respectively. Endoscopy scores of ≤1 at week 6 for the same groups were achieved in 55.8% vs. 46.8% (P=.0761) and 55.8% vs. 31.2% (P=.0004), respectively.

According to the researchers, “[Budesonide foam]  was generally well tolerated and provided a significant treatment benefit versus placebo for mild-to-moderate, distal forms of UC, irrespective of baseline oral 5-ASA use.”

For more information

Sandborn WJ. Abstract P470. Presented at: ACG Annual Scientific Meeting, Oct. 20-22, 2014; Philadelphia, PA.

Disclosure: The research was supported by a grant from Salix Pharmaceuticals. Sandborn serves as a consultant for Salix Pharmaceuticals. See the abstract for a full list of the researchers’ other relevant financial disclosures.