Background Recent studies have demonstrated that biologic agents can improve work productivity in patients with rheumatoid arthritis (RA). However, the long term consequences on work productivity, particularly in step down treatment strategies has yet to be explored.
Objectives To assess changes in work productivity in patients who have achieved response (DAS<2.6) using etanercept (ETN) 50mg+MTX who are then randomized to ETN 25mg+MTX vs. MTX vs. placebo.
Methods Patients included in the analysis were in employment entering into Phase II of the PRIZE trial and who had at least one follow-up. Phase I of this trial recruited patients with early, moderate-to-severe RA to an open-label ETN 50mg+MTX for 52 weeks. Phase II was a 39-week, randomized, and double-blind comparison of dose reduction to ETN25+MTX, MTX or Placebo in subjects who had achieved response during Phase I. During Phase II, patients with DAS28>3.2 at visit week 56 or 64 were given a boost of corticosteroids. The Valuation of Lost Productivity (VOLP), a validated instrument developed to estimate productivity impacts from a societal perspective, was completed approximately every 13 weeks. One of the main VOLP outcomes, the 3-month paid work productivity loss, was calculated as the sum of lost work hours attributable to absenteeism, presenteeism (reduced productivity while at work) and employment status changes.
Results A total of 120 subjects were included in our analyses. Patient demographic and disease characteristics at week 52 were not significantly different among the three treatment groups except patient global assessment of disease activity (0-100): 5.6 for ETN25+MTX, 4.8 for MTX and 10.4 for placebo. At week 52, the 3-month paid work productivity loss was 21.8 hours, 12.8 hours and 14.0 hours, respectively. The productivity loss increased at week 64 from week 52 and dropped at week 76 for all treatment groups. This could be attributed to patients who lost their clinical response status and received a booster at week 56, however did not respond (DAS>3.2) at week 64 and thus were withdrawn from the study. Nonetheless, the productivity loss continued rising after week 76 for the placebo group (71.9 hours at week 91) but not for the other two groups (21.9 hours for ETX25+MTX and 27.6 hours for MTX). In contrast, for patients who were also employed at baseline, the 3-month paid work productivity loss dropped sharply from 93.1 hours at baseline to 14.0 hours at week 39 and then flattened at week 52 (15.8 hours) during Phase I.
Conclusions The work productivity gain in Phase I as a result of ETN50+MTX was marginally lost in the dose reduction treatment arms, ETN25+MTX and MTX, with substantial losses observed in the placebo arm during Phase II of the trial.
Disclosure of Interest : W. Zhang: None declared, N. Bansback: None declared, H. Sun: None declared, R. Pedersen Employee of: Pfizer Inc., S. Kotak Employee of: Pfizer Inc., A. Anis Grant/research support: Pfizer Inc.