title: Baseline Oral 5-ASA Use and Efficacy and Safety of Budesonide Foam in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis: Analysis of 2 Phase 3 Studies.
abstract: Rectal budesonide foam is a second-generation corticosteroid efficacious for active mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. This subgroup analysis examined the impact of baseline oral 5-aminosalicylic acid (5-ASA) on the efficacy and safety of budesonide foam in patients with mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis.
  
  
  
  Patients received budesonide foam 2 mg/25 mL twice daily for 2 weeks, then once daily for 4 weeks, or placebo, with or without continued stable dosing of baseline oral 5-ASAs, for remission induction at week 6 (primary endpoint) in 2 identically designed, randomized, double-blind, phase 3 studies.
  
  
  
  Of the 267 and 279 patients randomized to treatment with budesonide foam or placebo (pooled population), 55.1% and 55.2%, respectively, reported baseline 5-ASA use. A significantly greater percentage of patients achieved remission with budesonide foam versus placebo, either with (42.2% versus 31.8%, respectively; P = 0.03) or without (40.0% versus 14.4%; P < 0.0001) baseline 5-ASA use at week 6. A significantly greater percentage of patients achieved a Modified Mayo Disease Activity Index rectal bleeding subscale score of 0 at week 6, regardless of baseline 5-ASA use (5-ASA, 50.3% versus 35.7%; P = 0.003: no 5-ASA, 45.8% versus 19.2%; P < 0.0001). The frequency of adverse events was comparable between groups, regardless of baseline 5-ASA use.
  
  
  
  Budesonide foam was efficacious and safe for induction of remission of mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis in patients receiving oral 5-ASA at baseline and those who were not (Clinicaltrials.gov: NCT01008410 and NCT01008423).
authors.affiliation: *NYU Langone Medical Center, Department of Medicine, New York, New York;†University of California San Diego, Department of Medicine, La Jolla, California;‡The University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois; and§Department of Medical Affairs, Salix Pharmaceuticals, Raleigh, North Carolina.
authors.forename: Brian P
authors.initials: BP
authors.lastname: Bosworth
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: David T
authors.initials: DT
authors.lastname: Rubin
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Harper
mesh_terms: D000284:Administration, Oral; D000285:Administration, Rectal; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D012809:Colon, Sigmoid; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D011349:Proctitis / Q000188:drug therapy*; D011350:Proctocolitis / Q000188:drug therapy; D012074:Remission Induction / Q000379:methods; D012720:Severity of Illness Index
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005938:Glucocorticoids; D019804:Mesalamine; D019819:Budesonide