SAT0187 Golimumab improves work productivity and activity impairment in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PSA): 1-year results from a non- interventional trial in germany
Authors: I. Klaudius, K. Krueger, S. Remstedt, A. Thiele
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background:</h3> Non-interventional studies (NIS) are essential instruments in pharmaceutical research not only for pharmaceutical companies but also for regulatory authorities or reimbursement bodies in Germany. Aside from direct costs caused by a disease, German sick funds as well as health authorities have a keen interest in indirect costs, such as costs derived from loss of work productivity. <h3>Objectives:</h3> It is the aim of this study to show the benefit of Golimumab (GLM) in work productivity and activity for RA, AS and PsA patients in Germany. The analysis was performed using the validated indication-specific <b>W</b>ork <b>P</b>roductivity <b>A</b>ctivity <b>I</b>mpairment (WPAI) Questionnaire as primary endpoint. The WPAI is rated to be the most psychometrically validated and frequently used instrument for measuring of health-related work-productivity. <h3>Methods:</h3> As primary endpoint, the change of work productivity impairment and ability for daily activities in month 3 (V1) versus baseline visit (V0) was evaluated. All 4 subscores of the WPAI were analysed: disease related absence from work (absenteeism), working while sick (presenteeism), total work productivity impairment (TWPI) and activity impairment with TWPI as primary score. In addition, an evaluation of the activity impairment in the mITT population (<b>m</b>odified-<b>I</b>ntention-<b>T</b>o-<b>T</b>reat) was performed. As exploratory endpoint, the change in work productivity/activity impairment after 6 months and 12 months versus baseline as measured by WPAI for PsA, RA and AS patients treated with Golimumab in German clinical practice was evaluated. <h3>Results:</h3> Of 748 patients (100%) who started treatment with Golimumab at V0 (baseline), 666 (89.0%), 634 (84.8%) and 552 patients (73.8%) continued treatment until V1 (Month 3), V2 (Month 6), and V3 (Month 12/end of observation period), respectively. Efficacy analyses were performed on the mITT population which included 700 patients (RA=237, PsA=235, AS=228) who had at least 2 documented visits. The statistically significant improvements (all p-values &lt;0.05) in the mean WPAI domain scores were maintained over the 12-month observation period in all 3 indications with a higher treatment effect regarding "activity impairment" and "presenteeism" than with "absenteeism". The magnitude of improvements in the 4 WPAI domains and the time course of improvements varied between the underlying disease (RA, PsA, AS). In general, the improvements in the 4 WPAI domains were greater in patients with AS and PsA compared to RA patients. A continuous improvement over time was seen in AS patients regarding the domain "activity impairment. A positive effect of pre-treatment with biologics (i.e. better improvement in WPAI) was seen in RA patients for 3 domains (TWPI", absenteeism, presenteeism), and in PsA patients for 2 domains (absenteeism, activity impairment). <h3>Conclusions:</h3> Golimumab s. c. 1 x monthly is an effective treatment in patients with RA, AS and PsA. All scores of the WPAI showed a significant (p&lt;0.05) reduction in mean score values in each indication. Golimumab leads to an improvement of work productivity and daily activities in all patients already within the first 3 months of treatment and provided sustained improvement in WPAI in patients with RA, PsA and AS. <h3>Disclosure of Interest:</h3> I. Klaudius Employee of: MSD Sharp &amp; Dohme GmbH, K. Krueger: None declared, S. Remstedt: None declared, A. Thiele: None declared