A238
ADALIMUMAB IMPROVES HEALTH-RELATED QUALITY OF LIFE FOR 52 WEEKS IN PATIENTS WITH ULCERATIVE COLITIS
W Sandborn1, G Van Assche2, R Thakkar3, A Lazar4, M Kron4, M Yang3, J Chao3, P Mulani3
1U of California, La Jolla, California, USA; 2University Hospital Gasthuisberg, Leuven, Belgium; 3Abbott, Abbott Park, Illinois, USA; 4Abbott GmbH and Co, Ludwigshafen, Germany
Aims: To investigate the effects of adalimumab (ADA) maintenance therapy on health-related quality of life (HRQOL) through 52 weeks (wks) in patients (pts) with ulcerative colitis (UC).
Methods: Four hundred ninety-four pts with moderate to severe UC (Mayo score, 6 to 12 points; endoscopic subscore, 2-3 points; anti-tumor necrosis factor [anti-TNF]-naïve and anti-TNF-experienced [40.3%]) who had failed conventional therapy were enrolled in a 52-wk, randomized, double-blind, placebo-controlled maintenance trial. ADA-treated pts received induction therapy (160/80 mg at Wks 0/2) and 40-mg every-other-week (eow) maintenance therapy. Pts with inadequate response could switch to open-label eow therapy after Wk 12 and subsequently to weekly therapy. HRQOL was measured by the Inflammatory Bowel Disease Questionnaire (IBDQ). The intent-to-treat population was analyzed. IBDQ response rates were compared between the treatment groups using the Cochran-Mantel-Haenszel test stratified for prior anti-TNF use whereas the chi-square test was used in anti-TNF-naïve pts. Non-responder imputation was used for response variables. For change of IBDQ scores, the ANCOVA model with treatment and prior anti-TNF status as factors and baseline value as covariate was used. Missing values were imputed through last observation carried forward (LOCF).
Results: Significantly more ADA-treated pts were IBDQ responders (increase in IBDQ score >=16 points from baseline) throughout Wks 8, 32,and 52 compared with placebo. Mean changes from baseline IBDQ scores were consistently greater for ADA- vs. placebo-treated pts (table). In anti-TNF-naïve pts, the improvements from baseline for IBDQ were 34±38 and 22±37 at Wk 8 (p=0.002), 33±43 and 24±43 at Wk 32 (p=0.03), and 33±44 and 23±42 at Wk 52 (p=0.02) for ADA and placebo, respectively. The IBDQ responder rates were 68% and 52% at Wk 8 (p=0.004), 42% and 27% at Wk 32 (p=0.006), 32% and 21% at Wk 52 (p=0.040) for ADA and placebo, respectively, among anti-TNF-naïve pts.
Conclusions: For pts with moderate to severe UC who failed conventional therapy, ADA was more effective than placebo for inducing and maintaining improvements in HRQOL, as measured by IBDQ through 52 wks.