Published online Jun 7, 2020. doi: 10.3748/wjg.v26.i21.2852
Peer-review started: February 6, 2020
First decision: March 21, 2020
Revised: May 8, 2020
Accepted: May 23, 2020
Article in press: May 23, 2020
Published online: June 7, 2020
The introduction of biologics has revolutionized the management of the chronic inflammatory bowel disease, ulcerative colitis (UC), with many patients experiencing significant improvements not only in their symptoms but in other outcomes relevant to individuals and society as a whole. In Germany, there are no prospective data > 3 mo that assess the work productivity, daily activities and quality of life (QoL) of patients with moderate-to-severe UC treated with golimumab.
To assess change in work productivity, capacity for daily activities and QoL in UC patients treated with golimumab in Germany.
The validated Work Productivity Activity Impairment (WPAI) Questionnaire was used to analyze the change in work productivity, the capacity for daily activities after three months (primary endpoint) and disease specific and health related QoL (HRQoL) up to 1 year (secondary endpoints). The changes in work productivity and activity impairment were evaluated every three months until month twelve compared to baseline. Disease-specific and health-related QoL were assessed with the inflammatory bowel disease questionnaire and with the short-form 12 health survey questionnaire (SF-12).
This prospective non-interventional study included 287 patients. The analysis population was comprised of 282 patients who had completed at least two visits. At baseline, 61% of patients had moderate UC and 18% had severe UC. Furthermore, 75% of patients worked full-time or part-time at baseline. A total of 212 patients who were employed at the start of the study (employed population) were evaluated for the primary endpoint. Golimumab significantly reduced all WPAI sub-scores compared to baseline after three, six, nine and twelve months after the start of treatment (P < 0.0001). In addition, disease-specific QoL and HRQoL, as measured by the SF-12 questionnaire, improved significantly with golimumab at all evaluation times (P < 0.0001 in each case vs baseline).
Treatment of moderate-to-severe UC with golimumab leads to significant improvements in patient’s work productivity, daily activity and QoL over twelve months.
Core tip: Systematic reviews indicate that ulcerative colitis (UC) causes a significant socioeconomic burden, but prospective studies are scarce. The aim of this study is to evaluate the changes in work productivity and quality of life (QoL) of UC patients in Germany treated with the human monoclonal tumor necrosis factor alpha antibody golimumab in order to assess the specific benefit of this treatment option. This prospective non-interventional study included 287 patients. Based on these data we were able to show that treatment of moderate-to-severe UC with golimumab leads to significant improvements in patient´s work productivity, daily activity and QoL over twelve months.