title: Mesalazine foam (Salofalk foam) in the treatment of active distal ulcerative colitis. A comparative trial vs Salofalk enema. The SAF-3 study group.
abstract: BACKGROUND
  Mesalazine enemas are of well proven efficacy for the topical treatment of distal ulcerative colitis. Although new rectal formulations of mesalazine are not expected to be superior in efficacy and tolerability to standard formulations, they may offer secondary advantages in terms of overall acceptability.
  
  
  OBJECTIVE
  To compare the efficacy, tolerability and overall acceptability of a new mesalazine rectal foam (Salofalk foam) with mesalazine enema in the treatment of active distal ulcerative colitis.
  
  
  METHODS
  A multicentre study was carried out in patients with active proctitis, proctosigmoiditis and left-sided ulcerative colitis as evaluated by the Clinical Activity Index (CAI > or =4) and Endoscopic Index (EI > or =6). Patients were randomly assigned to receive, in open-label fashion, either mesalazine foam 2 g twice a day or mesalazine enema (2 g/60 ml twice a day) for 3 weeks. Patients who did not achieve remission (defined as CAI <4 and EI <6) after 3 weeks continued the study receiving the alternative galenic formulation for a further 3 weeks.
  
  
  RESULTS
  A total of 195 patients were enrolled. Characteristics at baseline were similar except for concomitant therapy with oral 5-ASA products: during the 1st treatment phase, 41% of patients on enema received such treatment vs only 29% of those on foam. Patients with at least one post-treatment efficacy evaluation were included in the intent-to-treat analysis (n=89 foam, n=96 enema). After 3 weeks of treatment, 112 patients were in remission and only 59 patients entered the 2nd treatment phase thus providing data on acceptability. Remission was achieved after 3 weeks in 54% of patients treated with foam and in 67% of those treated with enema. The 90% confidence interval for the difference in remission rates was 0 to 24 and thus within the clinically acceptable range of therapeutic equivalence. At the end of the 2nd phase, 70% of patients switched to foam were in remission vs 65% to the enema. Two patients discontinued treatment with foam prematurely due to anal burning. No clinically important changes were seen in the laboratory tests.
  
  
  CONCLUSIONS
  Salofalk foam and enema are equally effective for the treatment of proctitis, proctosigmoiditis and left-sided ulcerative colitis. The new foam preparation is as well tolerated and accepted as enemas and can be used as a therapeutic alternative to conventional mesalazine enema formulations.
authors.affiliation: L. Sacco University Hospital, Milan, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Ardizzone
authors.forename: P
authors.initials: P
authors.lastname: Doldo
authors.forename: T
authors.initials: T
authors.lastname: Ranzi
authors.forename: G C
authors.initials: GC
authors.lastname: Sturniolo
authors.forename: L A
authors.initials: LA
authors.lastname: Giglio
authors.forename: V
authors.initials: V
authors.lastname: Annese
authors.forename: A
authors.initials: A
authors.lastname: D'Arienzo
authors.forename: E
authors.initials: E
authors.lastname: Gaia
authors.forename: S
authors.initials: S
authors.lastname: Gullini
authors.forename: G
authors.initials: G
authors.lastname: Riegler
authors.forename: M
authors.initials: M
authors.lastname: Valentini
authors.forename: P
authors.initials: P
authors.lastname: Massa
authors.forename: M
authors.initials: M
authors.lastname: Del Piano
authors.forename: F
authors.initials: F
authors.lastname: Rossini
authors.forename: C S
authors.initials: CS
authors.lastname: Guidetti
authors.forename: A
authors.initials: A
authors.lastname: Pera
authors.forename: R
authors.initials: R
authors.lastname: Greinwald
authors.forename: G
authors.initials: G
authors.lastname: Bianchi Porro
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D018592:Cross-Over Studies; D016099:Endoscopy, Gastrointestinal; D004733:Enema; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage* / Q000009:adverse effects; D010349:Patient Compliance; D017060:Patient Satisfaction; D011349:Proctitis / Q000188:drug therapy / Q000473:pathology; D011350:Proctocolitis / Q000188:drug therapy / Q000473:pathology
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine