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P181. Adalimumab improves health-related quality of life for 52 weeks in patients with ulcerative colitis

W.J. Sandborn1, G. Van Assche2, R.B. Thakkar3, A. Lazar4, M. Kron4, M. Yang3, J. Chao3, P.M. Mulani3

1University of California, San Diego, La Jolla, CA, United States; 2University Hospital Gasthuisberg, Leuven, Belgium; 3Abbott Laboratories, Abbott Park, IL, United States; 4Abbott GmbH & Co. KG, Ludwigshafen, Germany

Aim: To investigate the effects of adalimumab maintenance therapy on health-related quality of life (HRQOL) through 52 weeks in patients with ulcerative colitis (UC).

Materials and Methods: 494 patients with moderate to severe UC (Mayo score, 6–12 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-week, randomized, double-blind, placebo-controlled maintenance trial. Adalimumab-treated patients received induction therapy (160/80 mg at Weeks 0/2) and 40-mg every-other-week (eow) maintenance therapy. Patients with inadequate response could switch to open-label eow therapy after Week 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 patients. 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 adalimumab-treated patients were IBDQ responders (increase in IBDQ score ≥16 points from baseline) throughout Weeks 8, 32, and 52 compared with placebo. Mean changes from baseline IBDQ scores were consistently greater for adalimumab- vs. placebo-treated patients (table). In anti-TNF-naïve patients, the improvements from baseline for IBDQ were 34±38 and 22±37 at Week 8 (p = 0.002), 33±43 and 24±43 at Week 32 (p = 0.03), and 33±44 and 23±42 at Week 52 (p = 0.02) for ADA and placebo, respectively. The IBDQ responder rates were 68% and 52% at Week 8 (p = 0.004), 42% and 27% at Week 32 (p = 0.006), 32% and 21% at Week 52 (p = 0.040) for ADA and placebo, respectively, among anti-TNF-naïve patients.

Improvement in IBDQ Over Time
 Placebo (N = 246)Adalimumab (N = 248)
IBDQ at baseline (mean±SD)123±33128±29
IBDQ (mean±SD)
Week 820±3629±36a
Week 3220±4128±41a
Week 5219±4127±42a
IBDQ response, n (%)
Week 8112 (45.5)144 (58.1)b
Week 3254 (22.0)86 (34.7)b
Week 5240 (16.3)65 (26.2)b
Weeks 8, 32, and 5230 (12.2)58 (23.4)b
ap < 0.05. P-values from ANCOVA with treatment and prior anti-TNF status as factors and baseline value as covariate. bp < 0.05. P-values from Cochran-Mantel-Haenszel test stratified for prior anti-TNF use.

Conclusion: For patients with moderate to severe UC who failed conventional therapy, adalimumab was more effective than placebo for inducing and maintaining improvements in HRQOL, as measured by IBDQ through 52 weeks.