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

Abstract

I c ackground & Aims: The ACCENT II study (A Crohn’s isease Clinical Trial Evaluating Infiximab in a New ong-term Treatment Regimen in Patients With Fistulizng Crohn’s Disease) evaluated the efficacy and safety of nfliximab maintenance treatment in patients with fistuizing Crohn’s disease. This post hoc analysis was conucted to determine the efficacy and safety of infliximab herapy in women with rectovaginal fistulas. Methods: ll patients received 5 mg/kg infliximab intravenously at eeks 0, 2, and 6. Patients who achieved response at eeks 10 and 14 then were randomized as responders f they had at least 50% of baseline fistulas closed, or as onresponders, to receive placebo or infliximab 5 g/kg every 8 weeks through week 54. Results: Of 282 atients in the ACCENT II study, 25 of 138 (18.1%) omen had a total of 27 draining rectovaginal fistulas at aseline. After infusions of infliximab at weeks 0, 2, and , 60.7% (17 of 28) and 44.8% (13 of 29) of rectovagial fistulas were closed at weeks 10 and 14, respecively. Among responders, 72.2% (13 of 18) of rectovagial fistulas were no longer draining at week 14. The uration of rectovaginal fistula closure was longer in the nfliximab 5-mg/kg maintenance group (median, 46 wk) han in the placebo group (33 wk). Conclusions: Inflixmab is effective in short-term closure of rectovaginal stulas and maintenance treatment was more effective han placebo in prolonging rectovaginal fistula closure.