Original Contribution
The American Journal of Gastroenterology (2004) 99, 1984–1989; doi:10.1111/j.1572-0241.2004.40462.x
An Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Prior Loss of Response or Intolerance to Infliximab for Crohn's Disease
William J Sandborn MD1, Stephen Hanauer MD1, Edward V Loftus Jr. MD1, William J Tremaine MD1, Sunanda Kane MD1, Russell Cohen1, Karen Hanson RN, CNP1, Therese Johnson RN1, Debra Schmitt RN1 and Resa Jeche AS1
1Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota; and University of Chicago, Chicago, Illinois
Correspondence: William J. Sandborn, MD, Mayo Clinic, 200 First Street SW, Rochester, MN 55905
Received 22 April 2004; Revised 0000; Accepted 3 May 2004.
Abstract
BACKGROUND:
We assessed the tolerability and clinical benefit of adalimumab, a human antibody to tumor necrosis factor (TNF), in patients with Crohn's disease who had previously received and responded to the chimeric anti-TNF antibody infliximab, but who no longer had a sustained response and/or tolerance to infliximab.
METHODS:
A total of 24 patients with Crohn's disease who had lost responsiveness or developed intolerance (acute or delayed infusion reactions) to infliximab were enrolled in a 12-wk uncontrolled trial and treated with subcutaneous adalimumab 80 mg at week 0 and then 40 mg every other week starting at week 2. After week 4, the dose could be escalated to 40 mg weekly in patients who did not achieve clinical remission, complete fistula closure, and complete steroid withdrawal. Outcome measures included the ability to tolerate adalimumab and clinical remission (defined as a Crohn's disease activity index (CDAI) score 
150 points) and clinical response (defined as a decrease in the CDAI) 
100 points) in patients who had a baseline CDAI score 220.
RESULTS:
None of the patients experienced acute or delayed hypersensitivity reactions during treatment with adalimumab (including 14 who previously experienced treatment-limiting acute hypersensitivity reactions and 6 who previously experienced delayed hypersensitivity reactions with infliximab). Of 17 patients with baseline CDAI scores 220: clinical remission occurred at weeks 4 and 12 in 2 (12%) and 5 (29%), respectively; and clinical response occurred in 7 (41%) and 10 (59%), respectively. Nineteen patients (79%) escalated their dose during weeks 4–6.
CONCLUSIONS:
Adalimumab is well tolerated and appears to be a clinically beneficial option for patients with Crohn's disease who have previously lost their response to, or cannot tolerate infliximab.
