title: Long-term efficacy of infliximab maintenance therapy for perianal Crohn's disease.
abstract: OBJECTIVE
  To assess the long-term efficacy of seton drainage with infliximab maintenance therapy in treatment of stricture for perianal Crohn's disease (CD).
  
  
  METHODS
  Sixty-two patients with perianal CD who required surgical treatment with or without infliximab between September 2000 and April 2010 were identified from our clinic's database. The activities of the perianal lesions were evaluated using the modified perianal CD activity index (mPDAI) score. The primary endpoint was a clinical response at 12-15 wk after surgery as a short-term efficacy. Secondary endpoints were recurrence as reflected in the mPDAI score, defined as increased points in every major element. The clinical responses were classified as completely healed (mPDAI = 0), partially improved (mPDAI score decreased more than 4 points), and failure or recurrence (mPDAI score increased or decreased less than 3 points).
  
  
  RESULTS
  There were 43 males and 19 females, of whom 26 were consecutively treated with infliximab after surgery as maintenance therapy. Complete healing was not seen. Failure was seen in 10/36 (27.8%) patients without infliximab and 4/26 (15.4%) patients with infliximab (P = 0.25). Partial improvement was seen in 26/36 (72.2%) patients without infliximab and 22/26 (88.5%) patients with infliximab (P = 0.25). Short-term improvement was achieved in 48/62 (77.4%) patients. Although the mPDAI score improved significantly with surgery regardless of infliximab, it decreased more from baseline in patients with infliximab (50.0%) than in those without infliximab (28.6%), (P = 0.003). In the long-term, recurrence rates were low regardless of infliximab in patients without anorectal stricture. In patients with anorectal stricture, cumulative recurrence incidences increased gradually and exceeded 40% at 5 years regardless of infliximab. No efficacy of infliximab treatment was found (P = 0.97). Although the cumulative rate of ostomy creation was also low in patients without stricture and high in patients with stricture, no protective efficacy was found with infliximab treatment (P = 0.6 without stricture, P = 0.22 with stricture).
  
  
  CONCLUSIONS
  Infliximab treatment was demonstrated to have short-term efficacy for perianal lesions. Long-term benefit with infliximab was not proven, at least in patients with anorectal stricture.
authors: Department of Lower Gastroenterological Surgery, Hyogo College of Medicine, Mukogawacho 1-1, Nishinomiya, Hyogo 6638501, Japan. uchino2s@hyo-med.ac.jp
authors: Motoi
authors: M
authors: Uchino
authors: Hiroki
authors: H
authors: Ikeuchi
authors: Toshihiro
authors: T
authors: Bando
authors: Hiroki
authors: H
authors: Matsuoka
authors: Yoshio
authors: Y
authors: Takesue
authors: Yoshiko
authors: Y
authors: Takahashi
authors: Takayuki
authors: T
authors: Matsumoto
authors: Naohiro
authors: N
authors: Tomita
mesh_terms: D000293:Adolescent; D000328:Adult; D001003:Anal Canal / Q000473:pathology / Q000601:surgery; D000818:Animals; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D003251:Constriction, Pathologic / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D003424:Crohn Disease / Q000188:drug therapy* / Q000473:pathology* / Q000517:prevention & control / Q000601:surgery*; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D012007:Rectum / Q000473:pathology / Q000601:surgery; D012008:Recurrence; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab