Background/Purpose: Determining the effect of treatment on work productivity of subjects with rheumatoid arthritis (RA) is an important topic given that most sufferers develop the disease between 35 to 50 years of age and many experience functional loss that translates into reduced productivity and work disability. The Valuation of Lost Productivity (VOLP) is a validated instrument developed to estimate productivity impacts from a societal perspective according to the human capital (economic) approach to measuring worker productivity. The VOLP was included in the PRIZE trial: a phase IV, 121-week, prospective, 3-phase (open-label followed by randomized double-blind, and tapering/observational phases), parallel-group, multicenter, outpatient study.

Objective: To assess productivity changes (gains), as measured by the VOLP, in phase 1 of the PRIZE trial.

Methods: In Phase 1, MTX- and biologic-naïve patients with early, active RA (symptom onset ≤12 months from enrollment; DAS28 >3.2) received open-label ETN50/MTX for 52 weeks. The VOLP was completed approximately every 13 weeks. The changes in three main VOLP outcomes from baseline to week 52 were measured: 1) 3-month paid work productivity gains, the sum of increased worked hours after adjusting for absenteeism, presenteeism and employment status changes; 2) 7-day unpaid work productivity impact; 3) Total 3-month monetary productivity gains as the sum of paid and unpaid work productivity gains. Productivity impacts included direct impact of a worker’s own productivity as well as the spillover effect when team productivity is impacted and/or substitute worker productivity is considered. Bootstrapping methods were used to test the changes in VOLP outcomes.

Results: A total of 196 patients were employed at baseline and had at least one scheduled follow-up visit. The average age was 46 years and 68% were female. The patients had a high disease activity (DAS28=5.91) and moderate functional disability (HAQ=1.22). The paid work loss was about 111.7 hours in the past 3 months at baseline and decreased to 60.1 hours at week 52, with a gain of 33.43 hours per 3 months. Similarly, the gain in unpaid work was about 4 hours per week. Total costs of lost productivity in the past 3 months were €3,483 at baseline and were reduced to €843 at week 52, with total monetary gains of €1322 per 3 months. All the three main VOLP outcomes were improved significantly over the 52 weeks.

Conclusion:  Combination therapy with ETN50/MTX was associated with a significant productivity gain for patients with early RA who were still observed at week 52.