Long-term treatment of rectovaginal fistulas in Crohn's disease: response to infliximab in the ACCENT II Study

Clin Gastroenterol Hepatol. 2004 Oct;2(10):912-20. doi: 10.1016/s1542-3565(04)00414-8.


Background & aims: The ACCENT II study (A Crohn's Disease Clinical Trial Evaluating Infiximab in a New Long-term Treatment Regimen in Patients With Fistulizing Crohn's Disease) evaluated the efficacy and safety of infliximab maintenance treatment in patients with fistulizing Crohn's disease. This post hoc analysis was conducted to determine the efficacy and safety of infliximab therapy in women with rectovaginal fistulas.

Methods: All patients received 5 mg/kg infliximab intravenously at weeks 0, 2, and 6. Patients who achieved response at weeks 10 and 14 then were randomized as responders if they had at least 50% of baseline fistulas closed, or as nonresponders, to receive placebo or infliximab 5 mg/kg every 8 weeks through week 54.

Results: Of 282 patients in the ACCENT II study, 25 of 138 (18.1%) women had a total of 27 draining rectovaginal fistulas at baseline. After infusions of infliximab at weeks 0, 2, and 6, 60.7% (17 of 28) and 44.8% (13 of 29) of rectovaginal fistulas were closed at weeks 10 and 14, respectively. Among responders, 72.2% (13 of 18) of rectovaginal fistulas were no longer draining at week 14. The duration of rectovaginal fistula closure was longer in the infliximab 5-mg/kg maintenance group (median, 46 wk) than in the placebo group (33 wk).

Conclusions: Infliximab is effective in short-term closure of rectovaginal fistulas and maintenance treatment was more effective than placebo in prolonging rectovaginal fistula closure.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdominal Abscess / chemically induced
  • Abdominal Pain / chemically induced
  • Adult
  • Antibodies, Monoclonal / therapeutic use*
  • Arthralgia / chemically induced
  • Crohn Disease / complications
  • Crohn Disease / drug therapy*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Gastrointestinal Agents / therapeutic use*
  • Headache / chemically induced
  • Humans
  • Infliximab
  • Infusions, Intravenous
  • Nausea / chemically induced
  • Quality of Life
  • Rectovaginal Fistula / etiology
  • Rectovaginal Fistula / prevention & control*
  • Respiratory Tract Infections / chemically induced


  • Antibodies, Monoclonal
  • Gastrointestinal Agents
  • Infliximab