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
Processing time: 121 Days and 4.8 Hours
Ulcerative colitis (UC) represents a chronic inflammatory bowel disease with recurrent episodes of debilitating symptoms leading to an impaired health-related quality of life (HRQoL), especially in those patients with moderate-to severe UC. Besides HRQoL, in most of the patients, work productivity is negatively affected and an increased incapacity to work is reported due to UC. Therefore, UC causes additionally a substantial socioeconomic burden. Consequently, it is a considerable necessity to evaluate the impact of treatment options on work productivity and work life impairment. Golimumab, a human monoclonal tumor necrosis factor alpha (TNFα) antibody is indicated to treat moderate-to-severe UC in adult patients without effective response to conventional therapies and its use has led to significant decrease of symptom burden in treated subjects.
Until now, it is rarely evaluated how anti-TNFα therapy affected work life in patients with moderate-to-severe UC. In particular, there are no systematic data on the use of golimumab in patients with moderate-to-severe UC in Germany with regard to work life impairment, quality of life (QoL) and health economics.
The GO-CUTE study aimed to evaluate the changes in work productivity and HRQoL in UC patients treated with golimumab in Germany in order to assess the specific benefit of this treatment option. Changes in work productivity and the capacity for daily activities after three months represented the primary endpoint. The changes in HRQoL and disease specific QoL up to 1 year during golimumab treatment were defined as secondary endpoints.
This non-interventional, observational, prospective study was conducted in fifty gas-troenterological practices in Germany. Work productivity and activity impairment were analyzed using the validated Work Productivity Activity Impairment (WPAI) Questionnaire. Short-form 12 health survey questionnaire (SF-12) and inflammatory bowel disease questionnaire (IBDQ) were used to complete HRQoL and disease-specific QoL assessment.
Our results showed a significant reduction in all WPAI sub-scores after the start of treatment with golimumab for each time point (month three, six, nine and twelve) when compared to baseline data (for each visit P < 0.0001, Wilcoxon signed rank test). A quarter of patients achieved a reduction of at least 25% in the absenteeism sub-score and a reduction of at least 40% in the presenteeism sub-score after three months of golimumab treatment. After twelve months, in 80% of the subjects the absenteeism sub-score and in 85% of the patients the presenteeism sub-score was enhanced. Significant improvements were also detected for disease-specific QoL as well as for HRQoL during treatment with golimumab (P < 0.0001 vs baseline, Wilcoxon signed rank test) assessed by IBDQ and SF-12, respectively.
The results of the GO CUTE study demonstrated that golimumab treatment in patients suffering from moderate-to-severe UC significantly improves both patient´s work productivity and daily activity as well as HRQoL and disease-specific QoL. Furthermore, our data revealed that these benefits persisted over twelve months of treatment.
We were able to show a strong responsiveness of the WPAI to the treatment of moderate-to severe UC with golimumab, but evidence from randomized controlled trials is additionally needed for final conclusions.