Article Text
Abstract
Background and Importance Anti-TNF-alpha therapy, such as infliximab, is the initial choice among biologic treatments for inflammatory bowel disease (IBD) when conventional therapies fail. IBD can impacts patient‘s life quality. Therefore, integrate Patient Reported Outcome Measures (PROMs) offers a valuable approach to monitor ttreatment from the patient‘s perspective.
Aim and Objectives Assess disease impact in infliximab-treated patients affected with IBDs using PROMs.
Material and Methods Cross-sectional study. Patients were included if they were outpatients treated with infliximab 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, starting date of biological treatment, health status, previous biological treatment, concomitant immunosuppressive treatment. To determine health status, we used Harvey-Bradshaw Index (HBI) for CD and Partial Mayo Score Index (PMSI) for UC. Clinical pharmacists performed 2 questionnaires to evaluate PROMs at outpatient facilties: IBDControl (IBD-Control-8-score plus visual analogue 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 51 patients with CD and 20 with UC were included (mean age 44.4±13.5, 63.4% men).
The mean number of patients previously treated with biologic agents in CD and UC was 13.7% and 35%, respectively. In both groups the majority of patients were treated >6 months with their current biological agent (CD: 50, UC:19). Patients took concomitant treatment with oral immunosuppressants in 80.4% in CD and 65% in UC.
Health status by HBI in CD-group was: 43 remission-state, 5 mild-disease, 2 moderate-disease and 1 severe-disease. According to questionnaires: mean IBD-Control-8-score and VAS-score was 11.9±4.2 and 82±21.4, respectively. Mean IBD-Disk score was 33.6±27.4 (70.6% of patients <50 points).
Health status according to PMSI in UC-group was: 16 remission-state, 2 mild-disease and 2 moderate-disease. According to questionnaires: mean IBD-Control-8-score and VAS-scores was 12.6±4 and 90.1±20.3, respectively. Mean IBD-Disk score was 37.3±27.5 (60% of patients <50 points).
Conclusion and Relevance The results show that most patients in both groups were in remission as reflected in the IBD-Control-8 and VAS scores. IBD-DISK shows moderate daily life impact, with ≥60% scoring <50. Therefore, PROMs are useful tools and could be included within pharmaceutical practice strategies.
Conflict of Interest No conflict of interest.