P423 Early improvement in quality of life in patients with luminal Crohn's disease treated with adalimumab. Data from RAPIDA trial

Abstract

Introduction: Clinical response and patient's quality of life improve as a result of the direct benefit of Crohn's disease (CD) effective treatment. Rapidity of response to treatment in CD is a field of major interest, due to the importance of achieving the highest benefit in the shortest possible time. There are no studies specifically designed for early evaluation of the quality of life in patients with active CD receiving adalimumab therapy. The aim of this study was to evaluate the rapidity of improvement of quality of life in response to adalimumab therapy in adult antiTNF naive patients with active luminal (Harvey-Bradshaw Index >=8) moderate-to-severe CD, and with no response to a full and adequate course of therapy with corticosteroids and/or immunosuppressants. Aims & Methods: To this purpose we designed an interventional, prospective, open label, single arm and multicenter clinical trial. Quality of life was evaluated by using the validated questionnaires EuroQol-5D (EQ-5D) and the 36 items version of the Inflammatory Bowel Disease Questionnaire (IBDQ-36). Questionnaires were administered at baseline, day 4 and weeks 1, 2 4 and 12 with standardized adalimumab treatment (160 mg - 80mg - 40 mg eow). The modified intention to treat (mITT) population was the primary population for analysis and consisted of those patients enrolled in the study who had received at least one dose of adalimumab. Statistical analyses were performed by the t-test or the Wilcoxon signed rank test, as applicable. Result(s): Eighty-six patients were included. At baseline, the median EQ-5D index score was 0.68. EQ-5D scores improved significantly versus baseline, at day 4 and weeks 1, 2, 4 and 12, with median changes of 0.05 (p=0.0005), 0.05 (p<0.0001), 0.11 (p<0.0001), 0.10 (p<0.0001) and 0.11 (p<0.0001), respectively. Similarly, EQ-5D VAS median scores also improved significantly, compared to baseline (median score at baseline: 55.00), at day 4 and thereafter, with median changes of 5.00, 5.50, 9.50, 10.00 and 12.00, respectively (p <0.0001 at all time-points). Restoration of normal health (IBDQ-36 score 4209) was obtained in 9% of patients at day 4 and increased to 35% at week 12. Conclusion(s): Adalimumab produces rapid improvement of quality of life since day 4 in patients with moderate-to-severe Crohn's disease.