Assessing patient quality of life, symptoms, treatment satisfaction, work productivity, and experiences with TYSABRI® therapy for Crohn’s disease in a usual care setting



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This study examines the effects of TYSABRI on the health-related quality of life (HrQoL) outcomes, disease status and symptomatology, treatment satisfaction, productivity outcomes and healthcare utilization for patients with Crohn’s Disease (CD). A total of 241 patients consented to participate in the study, out of which 61 patients qualified for the baseline survey. After three-months of TYSABRI therapy, the follow-up survey was completed by 24 patients. Changes in outcome scores from baseline to the three-month follow-up were evaluated. The 24 patients with the three-month follow-up were, on average 41 years old and 62.5% percent were female. For those with follow-up, a significantly lower proportion of patients (41.7 percent) identified their CD severity as moderate to severe compared to 83.3 percent at baseline (p=0.001). The patients also reported experiencing a significantly lower mean number of CD relapses at follow-up (4.0) compared to baseline (6.8) (p=0.004). Improved median well-being scores (2.0 vs. 1.0; p<0.001) and improved median abdominal pain scores (2.0 vs. 1.0; p=0.001) were also reported at follow-up. The patient global assessment of HrQoL over the last 2 weeks was significantly improved at follow-up (2.0 vs. 3.0; p=0.006). Similar improved results were observed regarding their assessment of the impact of CD on HrQoL (7.0 vs. 5.0; p<0.001). A significant change of 32.0 points on the total Inflammatory Bowel Disease Questionnaire (IBDQ) scale (p<0.001) and significant improvements in each of the four component scales were also seen at follow-up (p≤0.05). Significant improvement was noted on the SF-36 PCS scale (mean change 7.0; p=0.001) and MCS scale (mean change 6.0; p=0.05). Significant improvements were observed in the scores for each of the four scales of the treatment satisfaction questionnaire at follow-up: effectiveness scale (28.6 vs. 63.0; p<0.001); side-effects scale (61.6 vs. 82.2; p=0.01); convenience scale (63.8 vs. 70.8; p=0.05); and global satisfaction scale (41.3 vs. 67.0; p<0.001). A significant decrease in the number of CD-related emergency room (ER) visits was observed between baseline and follow-up (1.3 vs. 0.7; p=0.03). For the productivity outcomes, the percent of planned household work lost due to absenteeism was significantly reduced (73.1 percent vs. 43.9 percent; p=0.02) and the total percent of planned hours lost was also reduced (87.3 percent vs. 64.4 percent; p=0.037).
These results indicate that TYSABRI is associated with significant improvement in HrQoL outcomes, CD disease severity, treatment satisfaction, ER visits and productivity outcomes.