Background: 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 naïve 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.
Methods: To this purpose we designed aninterventional, 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 – 80 mg – 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.
Results: Eighty 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<0.01), 0.05 (p<0.001), 0.11 (p<0.001), 0.10 (p<0.001) and 0.12 (p<0.001), 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 6.00, 5.00, 10.00, 10.00 and 13.00, respectively (p<0.001 at all time-points).
The comparison, versus baseline, of the IBDQ-36 overall score (median score at baseline: 143.50) at day 4 and weeks 1, 2, 4 and 12, also yielded statistically significant differences, with median improvements of 14.0, 18.0, 30.0, 42.0 and 32.0 respectively (p<0.001 at all time-points). Restoration of normal health (IBDQ-36 score >209) was obtained in 11% of patients at day 4 and increased to 31% at week 12.
Conclusions: Adalimumab produces rapid improvement of quality of life since day 4 in patients with moderate-to-severe Crohn's disease.