M1051 Depression and Anxiety Measures in Pediatric Inflammatory Bowel Disease

Abstract

INTRODUCTION: Adalimumab (ADA) has been shown to be efficacious for induction and maintenance of remission and for providing rapid and sustained improvements in quality of life (QOL) for adults with active Crohn's disease (CD) in Western countries. We assessed the effect of ADA on QOL in Japanese patients (pts) with moderate to severe CD. METHODS: M04-729 was a multicenter, randomized, placebo (PBO)-controlled, double-blind induction study of Japanese pts with moderately or severely active CD (CDAI 220-450). Pts were randomized to receive induction therapy at Weeks 0/2 with ADA 160/80 mg, ADA 80/40 mg, or PBO. Pts experiencing clinical response (decrease of ≥70 points from baseline CDAI score [CR-70]) at Week 4 in M04-729 comprised the randomized cohort of the 52-week, double-blind, PBO-controlled, maintenance study, M06-837, and were randomized to receive ADA 40 mg every other week (eow) or PBO. QOL assessments included the Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS). Improvements in QOL scores from baseline to Week 4 in M04-729 and to Weeks 0, 8, 24, and 52 in M06837 were calculated using LOCF imputation for missing data. QOL scores for ADA vs. PBO at each visit, as well as change scores between each visit and baseline, were compared using Student t-tests. RESULTS: In M04-729, induction therapy with ADA 80/40 mg or 160/80 mg significantly improved SF-36 MCS scores from baseline to Week 4 compared with PBO (mean changes for ADA 80/40 mg vs. PBO: 5.5 vs. -1.6, p=0.0002; mean changes for ADA 160/80 mg vs. PBO: 6.2 vs. -1.6, p=0.0005). The primary analysis group in M06-837 included 43 pts who received ADA induction therapy and were CR-70 responders at Week 4 in M04-729; 21 were randomized to ADA 40 mg eow and 22 were randomized to PBO. Pts receiving ADA demonstrated sustained improvements in IBDQ, SF-36 PCS, and SF-36 MCS scores over the 52-week study. ADA 40-mg eow treatment significantly improved IBDQ scores and SF-36 MCS scores compared with PBO at Week 8 in M06-837 (table). CONCLUSION: QOL for Japanese pts with moderate to severe CD was improved with ADA treatment. QOL Improvements in M06-837