Adalimumab for Patientʼs with Crohnʼs Perianal Fistulas

Abstract

Purpose: Infliximab (IFX) has been shown to be effective for treating perianal Crohn's disease (CD), but some patients develop intolerance or lack of response. Adalimumab (ADA) is a fully humanized anti-TNF antibody that has been shown to be safe and effective in patients (pts) with CD, including those pts who have lost response or are intolerant to IFX. Its utility in pts with perianal CD has not been proven. We report the outcomes of a series of perianal CD pts who were treated with ADA. Methods: Eight pts with complex fistulizing CD (3 – rectovaginal fistula, 1 – scrotal fistula, 2 – multiple perianal fistulas) who had either an adverse reaction or attenuated response to IFX were placed on ADA. Median pt age was 42, five (62.5%) were female. All pts received an 80mg loading dose of ADA. Seven were then placed on 40mg every other week (qow). One pt was placed on 40mg weekly at the onset of treatment. Immunomodulators were maximized [6MP/azathioprine −5 pts; methotrexate −2] and concomitant antibiotics [Cipro-5; Flagyl 1] were started in most pts. Two pts were on prednisone at time of presentation. Three pts were ultimately increased to weekly ADA dosing. Setons were placed in three patients (2 setons each). Therapy effectiveness was assessed by pt symptom report, physical examination, and endoscopic ultrasound (EUS). Results: Of the 8 pts evaluated, one was lost to follow-up. The median length of follow-up was 18 mns (12 – 24 mns). Four (57%) of the seven pts had complete cessation of drainage. Two (29%) pts had a significant decrease in fistula drainage. The median time for cessation of fistula drainage was six months. Of the four pts with cessation of drainage, three (75%) were on 40mg of ADA weekly while one (25%) was on 40mg qow. EUS was used in 7 of the pts at time of initiation of therapy to assess fistula activity. Five (71%) of seven pts had either complete or significant cessation of fistula drainage. In two (66%) of the 3 pts with seton placement, repeat EUS evaluations were used to evaluate healing and guide seton removal with complete cessation of drainage. Conclusions: ADA combined with seton placement may be effective in pts with complex perianal CD who have an attenuated response or intolerance to IFX. Prospective trials are warranted.