AB0888 Guselkumab Provides Sustained Improvements in Work Productivity and Daily Activity in Patients With Active Psoriatic Arthritis Through 2 Years of DISCOVER-2

Abstract

BackgroundPsoriatic arthritis (PsA) impacts patients’ (pts) work productivity (WP) and daily activity.1 DISCOVER-2 (D2), a Phase 3 trial of the selective interleukin-23 p19-subunit inhibitor guselkumab (GUS) in biologic-naïve pts with PsA,2 demonstrated significant improvements in pt-reported WP and daily activity following 1 year (Y) of GUS treatment.3ObjectivesAssess WP and daily activity impairment in D2 pts through 2Y. Estimate indirect savings associated with GUS treatment and assess changes in employment status.MethodsPts with active PsA received GUS 100 mg every 4 weeks (Q4W); GUS 100 mg at W0, W4, then Q8W; or placebo (PBO). At W24, PBO pts crossed over to GUS 100 mg Q4W. WPAI-PsA assesses PsA-related work time missed (absenteeism), impairment while working (presenteeism), and impaired overall WP (absenteeism + presenteeism) for pts employed at baseline (EBL) and daily activity for all pts, including those unemployed at baseline (UBL) during the previous week. Mean changes in WPAI-PsA domains were calculated for each multiple imputation (MI) dataset using an analysis of covariance (ANCOVA); the reported LS mean is the average of all MI datasets. Significance was defined as p<0.05. Among pts EBL, potential indirect savings from improved overall WP were estimated using 2020 European Union mean yearly wage estimate (all occupations) combined with LS mean change from BL in WPAI-PsA overall work impairment.4 A shift analysis evaluated proportions of pts employed vs unemployed by treatment group using observed data over time.ResultsPts EBL comprised 64% of the analysis cohort. Significant improvements in WP in pts EBL and in daily activity among all pts were observed with GUS Q4W/Q8W vs PBO at W24;3 mean improvements in WP and daily activity increased with continued GUS through 2Y (Table 1). Potential annual indirect savings from improved overall WP in pts EBL were €10,826 GUS Q4W, €12,712 GUS Q8W, and €10,948 PBO→ GUS Q4W at 2Y. Shift analysis showed relatively stable employment in pts EBL with GUS up to 2Y (>83% continued to work). Among pts UBL (36% of cohort), the proportion of pts employed increased by >20% through 2Y of GUS (Figure 1).Table 1.Model-Based Estimates of Change From BL in WPAI-PsA Domains1GUS 100mg Q4WGUS 100mg Q8WPBO (W0-24) → GUS 100 mg Q4W (W24-100)VisitW24W100W24W100W24W100Absenteeism, N145147147149162166 LS Mean (95% CI)-3.4 (-6.5, -0.3)-1.8 (-4.5, 0.9)-3.0 (-6.0, 0.1)-4.2 (-6.8,-1.5)-3.0 (-6.0, 0.04)-4.2 (-6.8,-1.6) Diff vs. PBO-0.4 (-4.6, 3.8)--0.01 (-4.2, 4.2)---Presenteeism, N145147147149162166 LS Mean (95% CI)-20.1 (-23.7, -16.6)-26.3 (-30.1,-22.5)-19.6 (-23.2, -16.1)-28.0 (-31.8, -24.2)-10.5 (-13.9, -7.0)-24.2 (-27.9, -20.5) Diff vs PBO-9.7* (-14.4, -5.0)--9.2* (-13.9, -4.5)---Work productivity, N145147147149162166 LS Mean (95% CI)-20.1 (-24.1, -16.1)-23.8 (-28.0, -19.6)-19.2 (-23.1, -15.2)-28.0 (-32.1, -23.8)-10.6 (-14.4, -6.8)-24.1 (-28.1, -20.1) Diff vs PBO-9.5* (-14.8, -4.2)--8.6* (-13.9, -3.3)---Daily Activity, N242242246246245245 LS Mean (95% CI)-20.5 (-23.3, -17.7)-29.2 (-32.2, -26.1)-21.2 (-23.9, -18.4)-28.0 (-31.0, -24.9)-9.9 (-12.6, -7.1)-26.6 (-29.6, -23.6) Diff vs PBO-10.6* (-14.4, -6.8)--11.3* (-15.1, -7.5)-1Mean changes in WPAI-PsA domains were calculated for each MI dataset using an ANCOVA; reported LS mean (95% confidence interval [CI]) = average of all MI datasets.*p<0.002ConclusionIn GUS-treated bio-naïve PsA pts, robust improvements in WP and daily activity seen at W24 were maintained and increased through 2Y of GUS. Long-term improvements in WP achieved may result in substantial indirect cost savings for GUS-treated pts. Rates of employment remained stable in pts employed and increased in those unemployed at BL.