TY - JOUR
AU - Mulani, P
AB - Purpose Adalimumab, a fully human anti-tumor necrosis factor (anti-TNF) monoclonal antibody, is approved for the treatment of Crohn's disease (CD) and has been shown to induce and maintain remission in patients with CD. The ACCESS (Adalimumab in Canadian SubjeCts With ModErate to Severe Crohn's DiSease) study was a Canadian-based, multicenter, open-label trial of 304 patients with moderately or severely active CD. The objective of this analysis was to evaluate adalimumab's ability to induce and maintain steroid-free remission in patients receiving steroids at baseline and to induce complete fistula closure in patients with fistulas at baseline. Methods The study population included patients naïve to biotherapy as well as patients who had failed infliximab therapy. Patients received induction therapy of 160-mg/80-mg adalimumab at Weeks 0/2, followed by 40-mg every-other-week maintenance dosing. If flare/nonresponse (as determined by the investigator) occurred during maintenance dosing, patients were allowed to change their regimen to 40 mg weekly at or after Week 8. Patients were to remain in the study for a minimum of 24 weeks or until adalimumab was commercially available for the treatment of CD in Canada. Endpoints included steroid-free remission (Harvey-Bradshaw Index [HBI] ≤4 and steroid-free), sustained steroid-free remission (steroid-free for at least 90 days and in remission), and complete fistula closure (closure of all fistulas that were draining at baseline). Data were analyzed using both nonresponder imputation (NRI) and as-observed methods. Results At baseline, 144 patients were receiving steroids and 68 patients had at least 1 draining fistula. Rates of steroid-free remission at Week 24 are summarized in Table 1, and fistula closure over time is summarized in Table 2. Table 1. Steroid Free Remission (HBI ≤4) at Week 24     Table 1. Steroid Free Remission (HBI ≤4) at Week 24     Table 2. Fistula Closure Over Time     Table 2. Fistula Closure Over Time     Conclusions In this 6-month, open-label trial, adalimumab maintenance therapy was effective in inducing and sustaining steroid-free remission and fistula healing in patients with moderate to severe CD. Adalimumab therapy was effective for both anti-TNF-naive and infliximab-experienced patients. Copyright © 2009 Crohn's & Colitis Foundation of America, Inc.
TI - P-0122: Adalimumab Therapy maintains steroid-free remission and Fistula Closure in patients with moderate to severe Crohn's Disease: Results of an Open-Label Study in Canada (ACCESS)
JO - Inflammatory Bowel Diseases
DO - 10.1097/00054725-200912002-00130
DA - 2009-12-01
UR - https://www.deepdyve.com/lp/oxford-university-press/p-0122-adalimumab-therapy-maintains-steroid-free-remission-and-fistula-Im2SpYMWIa
SP - S43
EP - S43
VL - 15
IS - suppl_2
DP - DeepDyve
ER -