P069 - The CARE trial: adalimumab improves work productivity and quality of life in patients with Crohn's disease

Abstract

Introduction:Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool that assesses the impact of disease on productivity. The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a simple, validated, 10-item instrument that assesses health-related quality of life (HRQOL) in patients with inflammatory bowel disease. In the Crohn’s Patients Treated With Adalimumab: Results of a Safety and Efficacy Study (CARE), the efficacy and safety of adalimumab in a large population of patients whose treatment approximated usual clinical practice were evaluated. In this analysis, we investigated the impact of adalimumab treatment on work productivity and HRQOL in CARE. Methods: A total of 945 patients with Harvey Bradshaw Index score >7 enrolled in this multicenter, open-label, European, Phase IIIb trial. The study population included patients naive to biotherapy and patients who had failed infliximab therapy (primary nonresponders [PNR] to infliximab, lost response to infliximab, intolerant of infliximab, and other infliximab failures). Patients received induction therapy of 160-mg/80-mg adalimumab at Weeks 0/2, followed by adalimumab 40mg every-other-week maintenance therapy through at least Week 20 (patients with flares/nonresponse could receive 40mg weekly at/after Week 12). In this analysis, patients’ work productivity, as measured by WPAI, and HRQOL, as measured by SIBDQ, were analyzed. The WPAI tool, as adapted for CD, measures the percentage of overall impairment in work productivity (including absenteeism and presenteeism) and daily activity due to CD (0%=no impairment, 100%=total loss of work productivity/activity). An absolute change of 7% in WPAI score is the minimum clinically important difference (MCID). SIBDQ total scores range from 10 70, with greater scores indicating better HRQOL. A 9-point change in SIBDQ is correlated with a 100-point change in CDAI score. Both measures were assessed at baseline and Weeks 4, 8, 12, and 20, and changes from baseline were analyzed using paired Student t-tests. Results: Mean age of patients was 35.3 years, and 60% were female. Mean baseline total daily activity impairment (TAI) was 57% (n = 907). For employed patients, total work productivity impairment score (TWPI) was 51% (n = 442) at baseline, indicating severe impairment. Baseline quality of life of patients was substantially impaired (SIBDQ mean = 37±10). Mean changes in WPAI components and SIBDQ are summarized by reason for infliximab failure (table). Overall, at Week 20, 57% (518/910), 62% (559/907), and 47% (208/442) of patients achieved improvement of SIBDQ of 9 points (correlated with 100-point change in CDAI), TAI of at least 7 points (MCID), and TWPI of 7 points (MCID) (NRI). Conclusions: Adalimumab therapy significantly improved work productivity and quality of life for patients with moderately to severely active CD, including those naive to anti-TNF therapy and those who had failed infliximab therapy. These improvements were observed as early as Week 4 and maintained throughout the study. Mean absolute change in SIBDQ and two WPAI subscores with adalimumab therapy at Weeks 4 and 20 in CARE by prior use of infliximab (observed)