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086

IMPACT OF ADALIMUMAB MAINTENANCE THERAPY ON PATIENT-REPORTED OUTCOMES IN FISTULIZING CROHN’S DISEASE (CD) IN THE CHARM TRIAL

BG Feagan1, JF Colombel2, EV Loftus3, DA Schwartz4, EQ Wu5, A Yu5, PF Pollack6, J Chao6, P Mulani6
1Robarts Research Institute, London, ON; 2Hepatogastroenterology, CHU Lille, Lille, France; 3Mayo Clinic, Rochester, MN, USA; 4Vanderbilt University Medical Center, Nashville, TN, USA; 5Analysis Group, Inc., Boston, MA; 6Abbott, Abbott Park, IL, USA

AIMS: To assess the effect of adalimumab (ADA) maintenance therapy on CD-specific health-related quality of life among randomized patients (pts) with draining fistulas at screening visits and baseline (BL) of CHARM, a Phase III, randomized, double-blind, placebo-controlled trial evaluating remission maintenance in pts with CD.1 Fistulas occur in 17%-43% of pts with CD2 and are associated with worsening quality of life. ADA has shown efficacy in complete and sustained fistula closure in CHARM.
METHODS: Inflammatory Bowel Disease Questionnaire (IBDQ) evaluations were conducted at BL and at Weeks 4, 12, 26, and 56 of the CHARM trial. IBDQ scores over time were compared between groups receiving ADA 40 mg every other week (EOW), ADA 40 mg weekly, or placebo (PBO) using analysis of covariance. The percentage of pts achieving =>16-point improvement in IBDQ from BL, the minimum clinically meaningful improvement, was compared using chi-square tests.
RESULTS: Pts with or without fistulas showed similar BL CDAI and IBDQ scores (mean CDAI: 314 vs. 311; IBDQ: 123 for both groups). Of 117 pts with fistulizing CD who entered the study, 75 had IBDQ measurements after Week 4 and were followed through Week 56. Statistically significant and clinically meaningful changes in mean IBDQ scores from BL and percentage of pts achieving =>16-point improvement in IBDQ from BL were observed through Week 56 of ADA maintenance therapy (see table).
TABLE: Change From BL IBDQ and % of Pts With => 16-Point IBDQ Gain at Week 56

Improvements from BL

PBO (n=26)

40 mg ADA EOW (n=21)

40 mg ADA weekly (n=28)

Total IBDQ (mean)21.643.5*46.8*
=>16-point IBDQ (%)46%76%*86%**
*p<0.05, **p<0.01, both vs. PBO.
CONCLUSIONS: In pts with fistulizing CD, ADA maintenance therapy is associated with sustained and clinically meaningful improvement in CD-specific quality of life as measured by the IBDQ.
REFERENCES: 1. Colombel JF, et al. Gastroenterology. 2007;132:52-65.
2. Schwartz DA, et al. Ann Intern Med. 2001;135:906-18.
Funded by Abbott Laboratories

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