Background and Importance The clinical manifestations of inflammatory bowel disease (IBD) compromise patient's daily life. In this regard, the use of Patient Reported Outcome Measures (PROMs) to determine health status, quality of life and treatment effectiveness from the patient’s perspective can add significant value in clinical practice.
Aim and Objectives Assess disease impact in patients affected with IBDs using PROMs.
Material and Methods Cross-sectional study including outpatients treated with biological agents for ulcerative colitis (UC) and Crohn's disease (CD) ≥18 years. Socio-demographic and clinical characteristics were collected from clinical records: age, gender, type of IBD, diagnosis year, biological treatment, starting date of biological treatment, previous biological treatment, concomitant immunosuppressive treatment, previous surgeries due to IBD and smoking habits. We used 2 questionnaires to evaluate PROMs: IBD-Control (IBD-Control-8 sub-score plus visual analog scale (VAS), that range from 0-16 and 0-100, respectively, higher scores representing better disease control) and IBD-Disk (that ranges from 0-100, higher score representing higher IBD daily-life burden).
Results 42 patients with CD and 21 with UC were included (mean age 44.25 ± 14.67, 54% men). 44 patients were treated with infliximab (69.84%), 9 with ustekinumab (14.29%), 7 with vedolizumab (11.11%), 2 with golimumab (3.17%) and 1 with adalimumab (1.59%). 22 (34.92%) were previously treated with biological agents. 4 were diagnosed during the last 18 months while others were diagnosed before. 44 patients (69.84%) took oral immunosuppressant. 60 were treated >6 months with their current biological agent, the other 3 cases for 3-5 months.
Mean IBD-Control-8 score was 12.41 ± 3.87. Mean VAS score was 87.19 ± 18.17. Mean IBD-Disk score was 33.22 ± 25.95 (69.84% of patients being below 50 points). 4 out of 63 cases had worse overall measurements (IBD-Control-8 score ≤7, VAS score ≤60 and IBD-Disk score ≥63). 3 were women with CD and smoking habits (2 current smokers and 1 ex-smoker). 3 of them were treated with infliximab and 1 with vedolizumab (3 requiring concomitant immunosuppressants). 2 required previous surgery.
Conclusion and Relevance This study adds novel literature on health status of these patients using PROMs. Measurements were generally favorable but 4 patients out of 63 had worse overall measurements. Literature on this topic is scarce. PROMs are useful tools that could be incorporated in pharmaceutical practice.
Conflict of Interest No conflict of interest
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