Introduction We investigated 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 494 pts with moderate to severe UC (Mayo score, 6–12 points; endoscopic subscore, 2–3 points; anti–tumour necrosis factor [anti-TNF]–naïve and anti-TNF–experienced [40.3%]) who had failed conventional therapy were enrolled in a 52-wk, randomised, double-blind, placebo (PBO)-controlled maintenance trial. ADA-treated pts received induction therapy (160/80 mg @ 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 Inflammatory Bowel Disease Questionnaire (IBDQ). Intent-to-treat population was analysed. IBDQ response rates were compared between treatment groups using Cochran-Mantel-Haenszel test stratified for prior anti-TNF use whereas χ2 test was used in anti-TNF-naïve pts. Non-responder imputation was used for response variables. For change of IBDQ scores, 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 PBO. Mean changes from baseline IBDQ scores were consistently greater for ADA- vs PBO-treated pts (Abstract PWE-253 table 1). In anti-TNF–naïve pts, 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 PBO, respectively. 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 PBO, respectively, among anti-TNF–naïve pts.
Conclusion For pts with moderate to severe UC who failed conventional therapy, ADA was more effective than PBO for inducing and maintaining improvements in HRQOL, as measured by IBDQ through 52 wks.
Competing interests W Sandborn Grant/Research Support from: Abbott, Consultant for: Abbott, G Van Assche Grant/Research Support from: Abbott, R Thakkar Shareholder with: Abbott, Employee of: Abbott, A Lazar Shareholder with: Abbott, Employee of: Abbott, M Kron Shareholder with: Abbott, Employee of: Abbott, M Yang Shareholder with: Abbott, Employee of: Abbott, S Patel Shareholder with: Abbott, Employee of: Abbott, J Chao Shareholder with: Abbott, Employee of: Abbott, P Mulani Shareholder with: Abbott, Employee of: Abbott.