Background/Purpose: To evaluate physical and mental health functioning, health state, and health-related quality of life (HRQoL) in patients with active psoriatic arthritis (PsA) treated with intravenously administered (IV) golimumab (GLM), an anti-TNFα monoclonal antibody.

Methods: In this Phase 3, multicenter, randomized, double-blind, placebo-controlled trial, adult patients (N=480) with active PsA naïve to anti-TNFa therapy (mean age=46 yr) received IV GLM 2 mg/kg (N=241) at Weeks 0 and 4 and every 8 weeks thereafter or placebo (N=239) at Weeks 0, 4, 12, and 20 with crossover to IV GLM at Week 24. Three self-report instruments were included: 1) Short Form Health Survey (SF-36), a generic instrument of physical and mental health functioning: scores for its Physical (PCS) and Mental Component Summary (MCS) and 8 subscales (physical functioning, role-physical, body pain, general health, vitality, social functioning, role-emotional, and mental health) each range from 0 to 100 with higher scores indicating better function; 2) EuroQol visual analog scale (EQ-VAS), a generic measure of current health state (0=worst health you can imagine to 100=best health you can imagine); 3) Dermatology Life Quality Index (DLQI), a disease-specific HRQoL instrument measuring impact of skin disorders on daily living (scores range from 0-30 with lower scores indicating lesser impact). SF-36 PCS and MCS at Week 14 were controlled secondary endpoints. Least square mean differences between the treatment groups were estimated using analysis of covariance controlling for methotrexate use and baseline score.

Results: Mean improvements from baseline with IV GLM vs placebo occurred as early as Week 8 in SF-36 PCS (8.0 vs 1.7) and MCS (5.0 vs 1.2) scores (Table 1). Greater mean improvements from baseline in PCS (p<0.001) and MCS (p<0.001) scores were seen with IV GLM vs placebo at Weeks 14 and 24. Greater mean improvements in all 8 SF-36 subscales at Weeks 14 and 24 were also observed with IV GLM vs placebo (p<0.001 for all). The percentages of patients achieving clinically meaningful change (5 points or greater) in PCS and MCS scores were higher in IV GLM vs placebo at Weeks 14 and 24 (PCS: 67.6% vs 29.7%, 69.7% vs 29.3%; MCS: 51.5% vs 26.4%, 46.9% vs 29.3%; p<0.001 for all). Mean EQ-VAS improvements were observed as early as Week 8 with IV GLM vs placebo (17.2 vs 3.7) and remained greater with IV GLM vs placebo at Weeks 14 and 24 (both p<0.001; Table 1). Mean changes in DLQI were observed with IV GLM as early as Week 8 (-7.2 vs -1.7; Table 1). Higher percentages of patients in the IV GLM cohort achieved DLQI scores of 0 or 1 at Weeks 14 (35.3% vs 9.8%; p<0.001) and 24 (40.7% vs 9.8%; p<0.001) vs placebo.

Conclusion: Adult patients with active PsA treated with IV GLM showed marked improvements from baseline vs. placebo in physical and mental health function, health state, and HRQoL as early as Week 8; improvements were maintained through Weeks 14 and 24.

*presented p values are nominal