S1056 Quality-of-Life Improvements in Patients with Crohn's Disease Treated for 3 Years with Adalimumab in An Open-Label Extension of CHARM

Abstract

Introduction: Adalimumab (ADA) was efficacious in the induction and maintenance of remission and in improving quality of life (QOL) for patients (pts) with Crohn's disease (CD) in CHARM.1,2 The current analysis assessed the long-term effects of ADA on QOL for pts in ADHERE, an open-label extension of CHARM. Methods: In CHARM, pts were randomized to placebo, 40-mg ADA every other week (eow), or 40-mg ADA weekly. Pts with flare/nonresponse could receive open-label (OL) ADA at/after Week 12. At the end of CHARM (56 weeks), pts could enter ADHERE; pts on blinded therapy received ADA eow and those on OL ADA maintained their therapy. In CHARM and ADHERE, pts could change from eow to weekly dosages for flares/nonresponse. Pts were followed for 3 years (yrs) from CHARM baseline. Efficacy and QOL were assessed by using the Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form-36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS). Results: This analysis included 328 ADA-treated pts who entered ADHERE. At both 2 yrs and 3 yrs from CHARM baseline, >50% of ADAtreated pts achieved IBDQ≥170 (Table). Statistically significant improvements in mean total IBDQ and SF-36 PCS and MCS scores were also observed at both time points. Conclusions: Clinically important improvements in QOL achieved with ADA in the CHARM trial were sustained through 3 yrs of ADA maintenance therapy.