P328. Multiple short-term dose intensifications are effective in Crohn's disease patients treated with adalimumab
S. Horst1, R. Ligler2, S. Armstrong1, S. Evans1, C. Duley1, J. Wagnon1, D. Beaulieu1, D. Schwartz1
1Vanderbilt University, Gastroenterology, Nashville, United States; 2Vanderbilt University, Internal Medicine, Nashville, United States
Background: Short-term dose intensification with Adalimumab (ADA) in patients (pts) with Crohn's disease (CD) who had improvement but lost response has been reported to be effective. The aim of this study is to report our experience in pts who have undergone multiple reinductions of ADA for CD.
Methods: A retrospective cohort of consecutive CD pts seen in a single tertiary care IBD clinic from Dec 2007 thru Oct 2011 with use of ADA with multiple reinductions secondary to loss of response was evaluated. Full reinduction (fRI) was defined as ADA 160 mg week 0 and 80 mg week 2, and microreinduction (mRI) was defined as an increase of ADA 80 mg qowk times 2, then to every other week or weekly dosing. Outcomes included: change in CD related medications; hospitalization or surgery; CRP; disease activity by Harvey–Bradshaw Index (HBI); and endoscopic improvement. Statistical analysis used Wilcoxon matched-paired test.
Results: 98 pts underwent at least 1 course of ADA dose intensification of which 17 pts had 2 fRI or mRI. Median age was 40 (range 23, 60), 11/17 (65%) were female, 5/17 (29%) were current smokers, and 10/17 (60%) had previous surgery. 5 had ileocecal disease, 6 had colonic disease, 4 had ileal and colonic disease, and 2 had perianal disease only.
At first reinduction, 1 had fRI and 16 had mRI. Median time after start to first reinduction was 749 days (97, 1529). Median follow up (FU) (first to second reinduction) was 425 days (42, 1025). All pts were able to continue ADA, 1 required an operation, 2 required hospitalization, and 3 required other med changes. 9 pts had repeat endoscopy: 4 had deep remission/improvement, 5 had unchanged, and 1 had worse disease. HBI was available for 13 pts and was statistically significantly decreased (5.3±3.2 to 2.4±1.7, p < 0.05). CRP was also statistically significantly improved (13.9±21.2 to 5.5±4.3, p < 0.05). 16/17 (94%) pts had improved disease based on HBI response/remission and/or endoscopic improvement.
At second reinduction, 2 had fRI and 15 had mRI. Median FU was 225 days (66, 548). All but 1 pt continued ADA, 1 was hospitalized and 1 required an operation. 8 pts had repeat endoscopy: 4 had deep remission/improvement, 4 had unchanged disease. Of 10 pts with available information at FU, 9/10 (90%) had improved disease based on HBI and/or endoscopic improvement.
Conclusions: Patients with CD on ADA who lose response are able to recapture response and stay on ADA with dose intensification, and this appears to be effective with multiple reinductions.