title: Strategies in maintenance for patients receiving long-term therapy (SIMPLE): a study of MMX mesalamine for the long-term maintenance of quiescent ulcerative colitis.
abstract: BACKGROUND
  This was a phase IV, multicenter, open-label, 12-14-month study to assess clinical recurrence in patients with ulcerative colitis (UC) who received maintenance treatment with MMX Multi Matrix System (MMX) mesalamine. A secondary outcome was the relationship between long-term efficacy and adherence.
  
  
  METHODS
  Patients with quiescent UC (no rectal bleeding; 0-1 bowel movements more than normal per day) were enrolled directly into a 12-month maintenance phase of the study during which they received MMX mesalamine 2.4 g/day given once daily (QD). Patients with active, mild-to-moderate UC at screening were enrolled into a 2-month acute phase; those who achieved quiescence could continue into the maintenance phase. The primary endpoint was clinical recurrence at Month 6.
  
  
  RESULTS
  Of the 290 patients enrolled, 208 entered the maintenance phase; 152 directly and 56 via the acute phase. Following 6 and 12 months of treatment, 76.5% and 64.4% of evaluable patients, respectively, were recurrence-free. The majority of evaluable patients at Month 6 (81.6%) and Month 12 (79.4%) in the maintenance phase were ≥ 80% adherent to MMX mesalamine. At Month 6, clinical recurrence was observed in 20.6% of patients who were ≥ 80% adherent and 36.1% of patients with <80% adherence (P = 0.05 [post-hoc chi-square analysis]); 31.2% and 52.5% at Month 12 (P = 0.01 [post-hoc chi-square analysis]).
  
  
  CONCLUSIONS
  MMX mesalamine 2.4 g/day QD is effective for maintaining quiescence in patients with UC. Furthermore, adherence to prescribed treatment yielded lower rates of clinical recurrence. Continued education regarding the importance of long-term 5-aminosalicylic acid therapy is warranted.
authors.affiliation: Department of Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA. kane.sunanda@mayo.edu
authors.forename: Sunanda
authors.initials: S
authors.lastname: Kane
authors.forename: Seymour
authors.initials: S
authors.lastname: Katz
authors.forename: M Mazen
authors.initials: MM
authors.lastname: Jamal
authors.forename: Michael
authors.initials: M
authors.lastname: Safdi
authors.forename: Ben
authors.initials: B
authors.lastname: Dolin
authors.forename: Dory
authors.initials: D
authors.lastname: Solomon
authors.forename: Mary
authors.initials: M
authors.lastname: Palmen
authors.forename: Karen
authors.initials: K
authors.lastname: Barrett
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D060046:Maintenance Chemotherapy; D008297:Male; D055118:Medication Adherence; D019804:Mesalamine / Q000008:administration & dosage*; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D012008:Recurrence; D012074:Remission Induction; D012307:Risk Factors; D013997:Time Factors
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine