Golimumab in real-world practice in patients with ulcerative colitis: Twelve-month results

Abstract

Background: 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.

Aim: To assess change in work productivity, capacity for daily activities and QoL in UC patients treated with golimumab in Germany.

Methods: 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).

Results: 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).

Conclusion: Treatment of moderate-to-severe UC with golimumab leads to significant improvements in patient´s work productivity, daily activity and QoL over twelve months.

Keywords: Golimumab; Non-interventional study; Quality of life; Ulcerative colitis; Work Productivity Activity Impairment (WPAI) Questionnaire; Work productivity.

Figure 1

Overview of mean work productivity and activity impairment (WPAI) domain scores comparison vs baseline in patients employed at baseline (employed analysis population). A: Patients with absenteeism; B: Patients with presenteeism; C: Patients‘ work impairment; D: Patients’ activity impairment. Bars represent the standard deviation. A significant reduction in all work productivity and activity impairment sub-scores after onset of golimumab therapy was detectable for each time point in comparison to baseline (for each visit P < 0.0001, Wilcoxon signed rank test). UC: Ulcerative colitis; BL: Baseline; n: Number of patients; SD: Standard deviation.

Figure 2

Inflammatory bowel disease questionnaire (IBDQ) score – change from baseline over time (total analysis population). The difference from baseline in the total IBDQ score was statistically significant for all visits (^aP < 0.0001, Wilcoxon signed rank test). Standard deviation is given in brackets.

Figure 3

Short form-12 health survey questionnaire - physical component score (PCS-12) and short form-12 health survey questionnaire - mental component score (MCS-12) – change from baseline over time (total analysis population). The difference from baseline in the PCS-12 as well as in the MCS-12 was statistically significant for all visits (^aP < 0.0001, Wilcoxon signed rank test). Standard deviation is given in brackets. PCS-12: Short form-12 health survey questionnaire - physical component score; MCS-12: Short form-12 health survey questionnaire - mental component score.