title: Early symptomatic response and mucosal healing with mesalazine rectal suspension therapy in active distal ulcerative colitis--additional results from two controlled studies.
abstract: BACKGROUND
  Rapid resolution of symptoms and endoscopic inflammation in ulcerative colitis (UC) represent important treatment goals.
  
  
  OBJECTIVE
  To establish times to bleeding cessation and endoscopic healing for topical and oral mesalazine in active distal UC, a post hoc analysis of two published studies was performed.
  
  
  METHODS
  Study I (Sutherland 1987) compared mesalazine rectal suspension to placebo, while Study II (Safdi 1997) compared topical suspensions, either alone or in combination with oral mesalazine, and oral alone. Cessation of rectal bleeding (RB) was defined as absence of bleeding on four consecutive days. Endoscopic remission was defined as DAI mucosal healing (MH) subscore=0 and clinical remission as MH subscore =0-1 and ≥ 1-point improvement, plus RB subscore = 0.
  
  
  RESULTS
  Study I: By Day 2, 31.4% of subjects using topical monotherapy reported no RB vs. 5.5% in the placebo arm (P<0.0006); median time to RB cessation was 8 days. Significantly higher rates of endoscopic (25.0% vs. 7.8%, P<0.005) and clinical remission (48.6% vs. 9.6%, P<0.0001) were observed at Week 3. Study II: A significantly higher proportion of subjects achieved RB cessation with combination therapy vs. oral therapy, commencing by Day 8. By Week 3, a significantly higher proportion of subjects using combination therapy achieved clinical remission compared to oral therapy alone (57.9% vs. 18.2%, P<0.05).
  
  
  CONCLUSIONS
  Topical mesalazine suspension, either alone or in combination with oral mesalazine, led to earlier rectal bleeding cessation and mucosal healing. These data support use of topical therapy for more rapid treatment benefit in active distal ulcerative colitis.
authors.affiliation: Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
authors.forename: W J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: S
authors.initials: S
authors.lastname: Hanauer
authors.forename: G R
authors.initials: GR
authors.lastname: Lichtenstein
authors.forename: M
authors.initials: M
authors.lastname: Safdi
authors.forename: M
authors.initials: M
authors.lastname: Edeline
authors.forename: M
authors.initials: M
authors.lastname: Scott Harris
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D006471:Gastrointestinal Hemorrhage / Q000517:prevention & control; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects*; D019804:Mesalamine / Q000008:administration & dosage*; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012007:Rectum; D013535:Suspensions / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D013535:Suspensions; D019804:Mesalamine