Health-Related Quality of Life in Patients with Crohnʼs Disease Improves Rapidly and Significantly During Adalimumab Treatment

Abstract

Purpose: Adalimumab (ADA) is approved for the treatment of adults with Crohn's disease (CD). CHARM was a 56-week, randomized, double-blinded, placebo-controlled, Phase III clinical trial of ADA efficacy and safety of patients (pts) with moderate to severe CD. Previous data from CHARM have demonstrated that ADA improved patients' health-related quality of life over 56 weeks1. Methods: We sought to assess the clinical importance of the rapid effect of ADA induction therapy on patient-reported outcomes (PROs) for all 778 pts who participated in randomization. In CHARM, pts received an induction regimen of open-label (OL) ADA 80 mg at baseline (Week 0) and 40 mg ADA at Week 2, followed by randomization to 40 mg every other week, 40 mg weekly therapy, or placebo at Week 4. PRO data, measured by the Short Form-36 (SF-36), Inflammatory Bowel Disease Questionnaire (IBDQ), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Zung Depression Scale, were collected at Weeks 0, 4, 12, 26, and 56. In this post-hoc analysis, changes in PRO measures from Weeks 0 to 4 were examined. The percentage of pts achieving the minimum clinically important difference (MCID) and the magnitude of changes were analyzed. MCIDs used in the analysis were 5 for each subscore of the SF-36 scale (Physical and Mental Component Summary scores), 16 for IBDQ, and 4 for FACIT-F. For the Zung Depression Scale, percentages of pts with symptoms of depression (Zung Depression Scale index ≥50) were compared between baseline and Week 4. Results: At baseline, all 778 pts had impaired quality of life as indicated by PRO scores. Pts improved rapidly across all PRO scores during the induction phase (Weeks 0 to 4). A majority of pts achieved clinically meaningful changes by 4 weeks (Table). The magnitudes of change were 20% to 140% higher than the MCID. Seventy-three percent of pts had symptoms of depression at baseline. By Week 4, this percentage had decreased to 49% (P < 0.001 vs baseline).Table: PRO Improvements at Week 4 of CHARMConclusion: ADA was associated with rapid and clinically significant improvement in patients' health-related quality of life. This research was funded by Abbott Laboratories, Abbott Park, IL.